PHARMACEUTICAL & BIOTECHNOLOGY
INDUSTRY UPDATE
July 2018
TABLE OF CONTENTS
UNITED STATES
Evonik Expands Manufacturing Capacity in US and Canada
Novacap to Expand Pharmaceutical Offering
Alta View Specialty Clinic, Sandy, Utah
Vertex Opens Expanded Research Site in San Diego
Aldevron GMP Plasmid Manufacturing Facility,
Fargo, North Dakota
Fresenius Kabi’s Pharmaceutical Manufacturing
Facility Expansion, Melrose Park, Illinois
Thermo Fisher Opens U.S. Precision Medicine Science
Center
Wuxi Biologics to Launch in US
Eisai to Launch Center for Genetics Guided Dementia
Discovery
Q Laboratories Opens New Lab Facility
LSNE Announces Acquisition of PSC Biotech’s
Parenteral Manufacturing Facility
Thermo Fisher Invests in
Biologics Footprint
Mayne Pharma Opens Oral Solid Dose Facility
REST OF WORLD
Telstar Wins Baccinex Design and Build Contract
Cherwell Laboratories Completes
Transition to ISO9001:2015
Tudertechnica Builds
Cleanroom for Silicone Hose
Sanofi Expands R&D
in China with Chengdu Hub
Tot Biopharm
Launches Mab Manufacturing Plant in China
Boehringer
Ingelheim Consolidates with Biologics Centre
Umicore API Facility Passes
cGMP Audit
Wuxi Biologics Expands
with ADC Build in China
Investment in Scotland to
Strengthen the UK’s Place in the Global Pharma Industry
Carleton University Health Sciences Building, Ottawa, Ontario, Canada
Juniper Pharma
Services Expands Lab Facilities
Jansen Group Completes Interior Of Ultramodern Belgium Hospital
Zoetis’ Animal Vaccine Research and
Manufacturing Complex, Suzhou
Samsung
BioLogics’ Third Manufacturing Facility, Songdo
Cambrex Expands in Italy and
Sweden
Cambrex Expands
Generic API R&D Capabilities
Parker Details Investment Timeline,
Launches New Single-Use System
Wasdell Group Invests in
New Microbiological and Analytical Lab
More on Cambrex New Lab Expansion
_________________________________________________________________________________________________________________________________________
UNITED STATES
Evonik Expands Manufacturing Capacity in US and
Canada
Evonik has announced a €35 million expansion
of its contract development and manufacturing capabilities in North America to
meet growing demand for controlled release injectable formulations. The
expansion of the US and Canadian facilities, which includes the installation of
a new filling line, production facilities and analytical labs, will create more
than 50 jobs.
The investment plan includes the installation
of automated vial filling line for advanced injectables, and the construction of
a new RESOMER production building at Evonik Birmingham Laboratories in Alabama,
US.
In addition, Evonik Vancouver Laboratories in
Canada will double in size to meet growing demand for its liposomal formulation
development and manufacturing services.
“Evonik is a global strategic partner to
pharmaceutical companies seeking enabling solutions for polymer and
liposome-based dosage forms,” said Don Enns, Global Head of Drug Delivery for
the Evonik Health Care Business Line.”
“By increasing the production capacity of our
RESOMER functional excipients and expanding our contract development and
production services, we can further help customers transform their APIs into
high-performance parenteral medicines.”
Birmingham Laboratories
Evonik Birmingham Laboratories (BHM) is a
global center of excellence for biomaterials and polymer-based injectable dosage
forms.
To further expand its range of parenteral
drug development and manufacturing services, Evonik has installed an automated,
custom-designed filling line for complex injectable products.
Supplied by Bausch + Stroebel and scheduled
to be fully operational later this year, the modular VarioSys line will support
the liquid, lyophilized or powder-filling of drugs in vial sizes of up to 50mL
to be used in clinical or commercial applications.
Evonik is also constructing a new 31,204 sq.
ft. (2,900 square meter) building at its BHM site that will significantly expand
the global production capacity of its RESOMER portfolio of bioresorbable
polymers. The new building, which is scheduled to be commissioned later this
year, will strengthen Evonik’s technological and supply leadership for
bioresorbable polymers and provide customers with additional dual-source supply
options.
Evonik Vancouver Laboratories:
In 2016, Evonik acquired Transferra
Nanosciences Inc., a CDMO specializing in the development of lipid
nanoparticle-based parenteral drugs. It is now named Evonik Vancouver
Laboratories.
To help meet growing demand for its advanced
CDMO services, Evonik is upgrading the existing facility and adding a second
adjacent building that will more than double the total size of its Vancouver
site to 46,268 sq. rt. (4,300 sq. m.)
The investments, which include the upgrade of
GMP manufacturing facilities and the expansion of laboratories and scale-up
services, will support new and existing customer programs.
Headquartered in Germany, Evonik is deemed
one of the world leaders in specialty chemicals. The company is active in over
100 countries around the world with more than 36,000 employees. In fiscal 2017,
the enterprise generated sales of €14.4 billion and an operating profit
(adjusted EBITDA) of €2.36 billion.
Mesquite, Texas To Receive 60-Acre ‘Wellness
Village’
Construction is anticipated to begin on the
initial phase in mid-2019.
The Verde at Peachtree is a new 60-acre
master-planned wellness campus in Mesquite, Texas that will serve the health and
well-being of the 700,000 people who live within 30 minutes of the development’s
planned location.
At full build-out the development will
comprise a $250+ million patient centered medical campus. The project is
designed to function as a walkable village with a 25+ acre amenity center that
follows the banks of a creek. The amenity center will include a series of
healing gardens, walking trails, a hotel and conference center, a fitness
center, and a senior living community.
The first phase of the project will include
the creation of over 15 acres and up to 600,000 sf of medical inpatient,
outpatient, and physician office facilities. Currently, final planning is
underway to begin site work, mass grading, and infrastructure improvements
necessary to tie Peachtree Road with an internal traffic circulation grid.
Verde Center at Peachtree is being developed
through a partnership between Ryan Companies US, Inc., Medical Campus Group,
Lang and Company, and the Peachtree Foundation, with development financing being
supplemented by financial incentives provided by the State of Texas and the City
of Mesquite.
Novacap to Expand Pharmaceutical Offering
Novacap, a worldwide player in pharmaceutical
synthesis and advanced specialties, announced that it has signed an agreement to
acquire Boston-based PCI Synthesis, a leading U.S. pharmaceutical contract
development and manufacturing organization (CDMO), further reinforcing Novacap’s
capabilities and offering for the pharmaceutical industry.
Located in Boston’s booming biotech and
pharmaceutical hub, PCI Synthesis offers its customers a wide range of services,
including process research and early stage development as well as commercial
production of new chemical entities (NCEs), generic APIs and other specialty
chemical products.
The company operates a R&D facility in
Devens, MA, and a manufacturing facility in Newburyport, MA, and generates a
turnover of $32 million. Leveraging its wide business offering and technologies,
proximity to customers, reactivity and undisputed project management skills, PCI
Synthesis has achieved tremendous growth over the last years, most recently
closing its fifth consecutive year-to-year of double-digit growth. This has been
driven by more than forty new customers and an expansion into new offerings such
as GMP manufacturing for nutraceuticals and pharma foods, large-scale cryogenic
manufacturing, large-scale chromatography, controlled substance development, and
medical-grade polymers. The company is North America’s most awarded drug
substance manufacturer and has become a strategic partner for the U.S.
pharmaceutical and biotechnology industries.
The combination of the two companies will
provide PCI Synthesis with additional resources to continue its development
while reinforcing Novacap’s global leadership in pharmaceutical synthesis with
12 cGMP sites, 2 main R&D centers and its comprehensive range of services and
technologies dedicated to clinical development and commercial manufacturing.
"This acquisition validates our strategy,
resources, offerings as well as our great employees and wonderful customers.
Since we started the company more than 20 years ago, we’ve continued to evolve
and innovate, and by teaming with Novacap, we will continue to do so, now with
access to Novacap’s deep technical expertise to better serve our customers,"
said Ed Price, Founder and President of PCI Synthesis.
“The acquisition of PCI Synthesis perfectly
fits with our strategic roadmap as it will strengthen our offering to the
pharmaceutical industry and provide Novacap with a strong and innovative
platform to accelerate our development in the U.S. We have been impressed by the
outstanding achievement of PCI Synthesis over the last years and its promising
pipeline of projects. The two companies operate complementary CDMO activities
and share common values such as entrepreneurship, operational excellence and
dedication to customer satisfaction. We look forward to working with the PCI
Synthesis team,” said Pierre Luzeau, CEO of Novacap.
The closing of this acquisition remains
subject to customary merger control approval.
BlackArch Partners served as the exclusive
financial advisor to PCI Synthesis.
Alta View Specialty Clinic, Sandy, Utah
Size: 108,000 sq. ft.
Project team: Perkins+Will’s LA studio (Head
Architect)
Description: The Alta View Specialty Clinic
is a 108,000 square foot, four story clinic. There are 840 patients per day,
anticipated in 2017 and 1,016 projected in 2022. The new clinic will provide
clinical space for a variety of primary and specialty care clinics, including
family medicine, internal medicine, pediatrics, senior clinic, allergy clinic,
cardiology, endocrinology, optometry and ophthalmology, InstaCare and KidsCare,
physical therapy/occupational therapy and speech, podiatry, pulmonary, infusion,
urology and orthopedics. In addition to these clinical areas, the new addition
will provide an optical shop, cafe, educational center and clinic administration
areas.
Completion date: December 2017
Vertex Opens Expanded Research Site in San Diego
Vertex Pharmaceuticals Incorporated announced
the opening of its new 170,000 square foot research facility in Torrey Pines,
San Diego. The new site represents a significant expansion of the company’s
research presence in the area, and its continued investment in the local
economy. The San Diego site is one of Vertex’s three global research hubs, and
is where the company’s three breakthrough cystic fibrosis (CF) medicines were
discovered.
“Our
researchers in San Diego have spent the last 20 years doing what was once
thought impossible – developing the first medicines that treat the underlying
cause of cystic fibrosis,” said Dr. David Altshuler, Executive Vice President,
Global Research and Chief Scientific Officer. “This team is a critical part of
our global research effort, and the new site will allow us to continue investing
in science to bring more transformative medicines to people with serious
diseases.”
More than 70 percent of the new facility is
dedicated to state-of-the-art lab and research space. It features a 1,500 square
foot learning lab for science, technology, engineering, arts and math (STEAM)
education programs, expanding on the company’s commitment to inspire and equip
the next generation of leaders in science; and a 4,000 square foot incubator
suite for external collaboration.
The new building, located at 3215 Merryfield
Row, is LEED Gold certified and is surrounded by two acres of dedicated outdoor
space. Construction of the new building was completed on schedule, in less than
18 months, and was overseen by Alexandria Real Estate. Vertex has committed to a
16-year lease to fully occupy the site.
Aldevron GMP Plasmid Manufacturing Facility,
Fargo, North Dakota
In March 2018, Aldevron initiated the
construction of a good manufacturing practice (GMP) compliant plasmid
manufacturing facility in Fargo, North Dakota, US.
Scheduled for completion in the second half
of 2018, the new facility is expected to be the world’s biggest plasmid DNA
manufacturing facility.
Aldevron is a biotechnology company based in
the US. It has made a $30m investment in the new facility, which is expected to
double the company’s GMP manufacturing capacity and enable it to meet the
growing demand for current good manufacturing practice (cGMP) products.
Aldevron’s new plasmid manufacturing facility
will have a total floor space of 70,000 ft², including 17,000ft² of modular
cleanrooms, which will be used for cGMP production.
The facility will also include ISO 8 and ISO
7 processing suites for cell banking and fermentation, as well as an
EU-compliant Grade A product dispensing zone. The fermentation scale of the
facility will range from 10l to 300l single-use systems, with provision for
expansion to 2,000l in the future.
The product-dispensing and cell-banking
suites will feature single-pass airflow, and the production area will feature a
unidirectional personnel flow and airlocks. The cleanroom systems at the
facility will be designed to provide customers with high-quality manufacturing.
The facility will also be equipped with an
emergency generator back-up power, automated alarms and environmental
monitoring.
The new facility will provide high-quality
plasmid DNA manufacturing services using single-use fermentation (SUF)
technology, which minimizes the need for costly cleaning validations and reduces
the time between GMP production runs.
The plant will produce a variety of plasmid
DNA catalogue items, which will be used to carry out research in mammalian
cells. It will produce research-grade plasmid DNA, GMP-Source™
plasmid DNA, and GMP plasmid DNA.
The research-grade plasmid DNA is used in
research applications in small, mid-size, large and high-throughput production
scales, while the GMP-Source™ plasmid DNA is used as a subsidiary or critical
raw material for manufacturing protein and viral candidates used in clinical
trials.
Aldevron provides a range of customized GMP
plasmid DNA services ranging from early research to commercial supply.
US-based cleanroom expert AES Clean
Technology was contracted to design and construct the new GMP plasmid
manufacturing facility.
Marketing commentary on Aldevron:
Headquartered in Fargo, North Dakota,
Aldevron was initially established as a small laboratory in the North Dakota
State University in 1998. It later expanded into a biotechnology firm
specializing in the production of nucleic acids, proteins, plasmids, RNA, gene
editing enzymes and antibodies.
Aldevron provides clients with critical raw
materials and key components, which are used for a wide range of research,
pre-clinical, clinical, diagnostic and commercial applications, including gene
therapy, gene editing and immunotherapy programs.
The company’s client base spans from some of
the largest pharmaceutical companies to small start-ups.
Its Fargo site spans seven acres and includes
a 50,000ft² GMP facility.
Fresenius Kabi’s Pharmaceutical Manufacturing
Facility Expansion, Melrose Park, Illinois
In August 2016, German pharmaceutical company
Fresenius Kabi announced a proposal to expand its pharmaceutical manufacturing
capabilities at the Melrose Park village site in Illinois, US.
The expanded facility will be used to produce
generic sterile injectable pharmaceuticals for hospitals and clinics across the
US.
Construction commenced in September 2017 and
the facility is expected to be fully operational by 2026. The expansion will
create new jobs for construction and highly skilled workers in Melrose Park.
The expansion will see the construction of
new buildings at Fresenius Kabi’s existing 124,267ft² plant In Melrose Park,
which was built in 2008 at 2020 N Ruby St.
The site is located in a general industrial
area in the outskirts of Chicago, five miles away from the O`Hare International
Airport. It employs approximately 700 people.
The plant currently produces a wide range of
generic injectable medicines for the treatment of critically and chronically ill
patients.
Fresenius Kabi will add four new buildings to
the site, with a total floor space of 130,000ft². The facility will include
space for highly automated manufacturing, offices, warehousing of materials, and
utilities.
The expansion is expected to support the
production of injectable drugs used for anesthesia, pain management, cancer
treatment and eliminating infections. The project will be completed to meet the
latest regulatory and quality requirements.
The new facility will be equipped with a
state-of-the-art urban manufacturing campus, including fully-automated aseptic
filling lines and sophisticated isolator technology, as well as expanded freeze
capabilities and formulation areas. It will also include a dedicated warehouse
for raw materials and components, alongside an administration building with a
conference center, laboratories, office spaces and a cafeteria.
The multi-stage, multi-year project is
expected to be completed in ten years, with an estimated investment of $250m.
Fresenius Kabi is expected to receive $15m in
tax-increment financing subsidies from Melrose Park village if it spends at
least $80m on the expansion. The company is also expected to obtain subsidies
for water usage, while Cook County will offer a 12-year property tax reduction.
Fresenius Kabi will also receive state tax
credits for the expansion from the Illinois Department of Commerce and Economic
Opportunity.
The new facility at the Melrose Park site was
designed by CRB.
Gilbane Building Company was awarded the
general construction contract for the new facility.
Marketing commentary on Fresenius Kabi:
Headquartered in Germany, Fresenius Kabi is a
global healthcare company engaged in the development of medicines and
technologies for infusion, transfusion and clinical nutrition.
Fresenius Kabi’s US headquarters is located
at Lake Zurich, Illinois. The company’s pharmaceutical manufacturing centers are
located at Bensenville, Skokie, Lake Zurich, and Melrose Park in Illinois. It
also has manufacturing sites in New York, North Carolina and Pennsylvania.
The company’s US manufacturing sites mainly
focus on the development of pharmaceuticals, but also manufacture medical
devices and clinical nutrition products. Fresenius Kabi has a total workforce of
approximately 2,500 people across the country.
Thermo Fisher Opens U.S. Precision Medicine Science
Center
Thermo Fisher Scientific has opened its U.S.
Precision Medicine Science Center (PMSC) in Cambridge, MA. The center offers
access to advanced "omics" technologies and expertise to help collaborators
develop analytical workflows that generate precise molecular profiles of
patients. This information will ultimately be used in clinical settings to more
effectively treat disease.
In addition, the company said the PMSC's team
of in-house scientists helps partners develop standard protocols that enable
them to compress R&D timelines and quickly progress from biomarker discovery to
assay development. The team includes Thermo Fisher experts in biochemistry, mass
spectrometry, molecular biology and data science.
"For health and science innovators, a
bottleneck exists today between the discovery of biomarkers and their widespread
use at the point of care," said Emily Chen, senior director, Thermo Fisher
Precision Medicine Science Center. "Our goal at the PMSC is to remove that
bottleneck and help scientists and physicians reduce the time it takes to
demonstrate clinic validity and utility."
"Precision medicine needs to be based on
high-quality data, and proteomics is central to that," said PMSC collaborator
Jennifer Van Eyk, Cedars-Sinai Medical Center in Los Angeles. "Our work with the
team at the PMSC is helping us accelerate the important journey from discovery
to patient care."
The PMSC offers access to advanced
technologies spanning genomic, proteomic and metabolomic analysis. From
analyzing genomic data with next-generation sequencers to identifying proteins
and metabolites using advanced mass spectrometry, collaborators can rapidly move
from research to clinical workflow development. With support from the PMSC,
scientists can:
Put complex analytical technologies at the
center of simplified workflows;
Generate reproducible research with an
emphasis on scalability and, ultimately, clinical utility;
Enable processes that produce the highest
quality data, consistently;
Change the culture of method sharing so a
larger community can benefit; and
Overcome lack of technical expertise as a
barrier to discovery by quickly accessing the best tools and skillsets
needed.
In 2017, Thermo Fisher opened its Precision
Medicine Science Center in Guangzhou, China. Like the PMSC, the Guangzhou Center
serves as a hub for partners seeking to establish standardized precision
medicine platforms as well as for joint research and development.
Wuxi Biologics to Launch in US
WuXi Biologics has announced plans to build a
$60m manufacturing facility – offering continuous manufacturing options – for
clinical and commercial production in the US.
The Chinese contract development and
manufacturing organization (CDMO) will invest $60m (€51m) in the Worcester,
Massachusetts-based site and hire approximately 150 employees.
The so-called “factory of the future” will
house approximately 4,500L bioreactor capacity, with two 2,000L traditional
fed-batch and one perfusion-based for continuous processing.
“Based on what we understand on the
competition, this is likely the first GMP [good manufacturing practice] facility
offering continuous manufacturing option,” CEO Chris Chen said.
The facility – which Chen said is located
within two hours of a number of WuXi Biologics partners – responds to the global
demand for increased manufacturing capacity.
“We have a growing portfolio of 161 molecules
to be developed from global clients as of Jan 1 2018. Based on progress of the
pipeline we know when we need capacity and how much we need. We then plan it in
our global manufacturing network,” he explained.
According to Chen, the passing of the Tax
Cuts and Jobs Act of 2017 – which reduced the US corporate tax rate from 35% to
a flat 21% - also makes the US an attractive option for investment.
“[The] lower tax rate definitely makes the
investment thesis much stronger than last year,” he said.
The investment marks WuXi Biologics’ eleventh
drug substance manufacturing facility globally and its third outside of China.
In late April this year, the firm said it
planned to build a biologics manufacturing facility in Ireland. The following
month, WuXi Biologics announced plans to expand manufacturing to Singapore with
the construction of a $60m facility.
Eisai to Launch Center for Genetics Guided
Dementia Discovery
Eisai will launch the Eisai Center for
Genetics Guided Dementia Discovery, which will harness the power of human
genetics to develop next-generation medicines for Alzheimer's disease (AD) and
other dementias. Guided by emerging insights from human genetics, coupled with
Eisai's recognized strengths in neuroscience and novel chemistry, the Center
will specialize in immunodementia drug discovery.
It will be located in a new, dedicated
state-of-the-art facility in Cambridge, Mass. Eisai plans to commit over $100
million as an initial investment to establish the new discovery center over the
first three years, and anticipates substantially increasing funding as its
pipeline develops.
"By focusing on human genetics, our discovery
labs have recently made rapid progress towards the next horizon of targeted
immunodementia medicines. Recognizing this advancement, Eisai plans significant
investment over the next 10 years in dedicated research funding to further
accelerate human genetics-guided drug discovery at the new Eisai Center for
Genetics Guided Dementia Discovery in Cambridge," said Ivan Cheung, chairman and
CEO of Eisai Inc. "With this commitment to R&D, our robust pipeline and Eisai's
successful legacy in AD treatments, we believe we will be able to accelerate our
efforts towards identifying the next-generation of dementia therapeutics to help
millions of patients and their caregivers."
The new 50,000-square-foot facility is being
constructed in the Alewife Research Center in Cambridge, and is expected to be
fully operational in early 2019. At that time, Eisai will close its current site
in Andover, Mass., and transition operations to the new Center in Cambridge.
Nadeem Sarwar, president of the Andover Innovative Medicines (AiM) Institute,
will lead the new site.
The Center will be organized around four key
functions: data sciences, immunodementia, discovery technologies, and precision
chemistry.
"Innovations in human genetics and related
sciences enable the discovery and development of novel therapeutics with
increased odds of success. Over the last two years, at the AiM Institute as well
as through our network of external collaborators, we have focused not only on
how human genetics can help identify and validate therapeutic targets and their
biomarkers, but also guide novel chemistry approaches to drug such targets,"
said Sarwar.
"This integrated approach has yielded
exciting drug discovery progress in a short time-frame, especially for immune
targets in pathways highlighted by human genetics. Creation of the new Center in
Cambridge provides Eisai with the opportunity to build upon these successes and
take a leadership position in human genetics-guided drug discovery. We will
apply our unique novel precision chemistry approach in the context of human
genetics to deliver tailor-designed small molecule and anti-sense
oligonucleotide solutions. Our goal is to discover next-generation targeted
immunodementia therapies to complement and go beyond targeting A-beta and tau."
The Cambridge biotech hub location has been
strategically selected to enable Eisai to focus on and identify new scientific
and business relationships for drug discovery, while providing the company with
greater access and flexibility to foster its current collaborations with
research institutes and strategic partners. Eisai already has a presence in
Cambridge through its subsidiary H3 Biomedicine, a clinical stage
biopharmaceutical company specializing in precision cancer therapeutics.
According to statistics from the Alzheimer's
Association, AD currently affects more than 5.7 million people in America, and
results in an estimated $277 billion cost to the nation. Over 14 million
Americans are predicted to be living with Alzheimer's by 2050, which would have
an estimated $1.1 trillion cost to the U.S.
Q Laboratories Opens New Lab Facility
Q Laboratories has opened its new
30,000-sq.-ft. lab in Cincinnati, OH. Completion of this new facility combined
with the purchase of two existing buildings on adjacent property will comprise
the Q Laboratories Campus allowing for continued growth and a more efficient
workspace for its 130+ employees. With this expansion the company’s total square
footage grows from 25,000 to 55,000, with plans to expand again in three to five
years.
David Goins, chief operating officer, has
been with the company for more than 29 years and has seen the company grow from
a small regional firm to a large organization serving companies around the
world. “We have been fortunate to have a fantastic team that has enabled us to
continue to grow,” Mr. Goins said. “Opening this beautiful new building is a
testament to the dedication of all of our employees and the excellence they
bring to the lab each and every day. This is a proud day for all Q Laboratories
employees, past and present. With any successful business, it takes talented
personnel to make it work. Q Laboratories history is filled with exceptional
people doing extraordinary work.”
Founded in 1966, Q Laboratories provides
microbiology, analytical chemistry, and research and development laboratory
services to the pharmaceutical, cosmetic, health and beauty care, and dietary
supplement industries. The lab offers quality control and testing services for
manufacturers and distributors, including method development and validation,
pathogen detection, elemental impurities analysis, raw material qualification,
microbial identification, and stability studies.
LSNE Announces Acquisition of PSC
Biotech’s Parenteral Manufacturing Facility
April 23, 2018, Bedford, NH – Lyophilization
Services of New England (LSNE), a leading contract development and manufacturing
organization (CDMO), announced that it has acquired PSC Biotech’s cGMP aseptic
fill finish manufacturing facility located in Madison, Wisconsin.
This acquisition allows LSNE to expand its manufacturing capabilities,
add new service offerings and accommodate its customers’ project timing
requirements. The new facility
will be called LSNE-Madison.
Financial terms of the transaction were not disclosed.
LSNE-Madison is a 37,000 square foot
multi-product facility that will be used for the manufacturing of final drug
products for pre-clinical to Phase III/commercial use.
The facility currently includes a high speed, automated aseptic fill line
and a 144-square foot lyophilizer with existing space for additional equipment
and the ability to expand to over 100,000 square feet of production space over
time.
The facility will complement LSNE’s existing
full-service parenteral manufacturing capabilities, which include vial filling,
lyophilization, process development, QC analytical, secondary packaging,
stability studies and regulatory support for clinical and commercial products at
its three other FDA-inspected manufacturing sites.
This new facility will also increase LSNE’s capabilities to include the
terminal sterilization of final product and additional quality control services.
“This acquisition is a key part of our
strategic growth plan to increase our operations and capacity and better serve
our customers,” said Matthew Halvorsen, Chief Executive Officer at LSNE.
“We have experienced strong growth and increased demand over the last few
years, and as the market continues to expand, we know it is imperative to be
able to offer increased scheduling flexibility to existing and new clients. With
the support of the Permira Funds, we are increasing our capacity to provide our
clients with additional manufacturing redundancy backed by the outstanding level
of service that LSNE is known for.”
“With this acquisition, we are gaining strong
talent that complements LSNE’s experienced and successful teams,” says Shawn
Cain, Chief Operation Officer at LSNE.
“We look forward to working with the staff to build LSNE-Madison into a
world class aseptic fill/finish facility focused on the manufacturing of
lyophilized and liquid drug products. “
LSNE anticipates full manufacturing
activities to commence later this year, following a short period of renovation
and validation of the facility.
Additional information regarding the acquisition and capabilities will be
available on LSNE’s website.
About PSC Biotech
PSC Biotech is global life sciences
technology company serving customers in North America, Europe, Asia, South
America and the Middle East. PSC
Biotech provides professional technical services such as commissioning,
qualification, validation project management, regulatory affairs, quality,
compliance, conceptual engineering, Information Technology, metrology services,
computerized system validation, etc., to life science, pharmaceutical and
software companies. It also provides
world class enterprise quality management software solutions – Adaptive
Compliance Engine™ (ACE) and AuditUtopia™.
About LSNE
LSNE is a privately held company with four
GMP facilities – three located in New England and one in Madison, WI.
LSNE has been providing contract lyophilization services to the
pharmaceutical, biotechnology and medical device industries since 1997,
specializing in a wide range of services including cycle development, cGMP fill
finish, and lyophilization. Through
the thoughtful integration of four processing facilities, qualified staffing,
and an extensive manufacturing history, LSNE is strategically positioned to
provide products and services for clinical through commercial supply for
pharmaceuticals and medical devices to a multi-national market.
Thermo Fisher Invests in
Biologics Footprint
Thermo Fisher Scientific is investing $50
million in its St. Louis, MO site, one of the company's Centers of Excellence
for biologic commercial manufacturing. The investment is part of the company’s
expansion strategy for its global network of biologic drug substance
capabilities for clinical and commercial supply.
The project includes expansion of the
existing manufacturing building with an additional 64,000 sq. ft., which will
double manufacturing capacity and will be operational in 2019. The expansion
will use the Thermo Fisher bioproduction "eco-system" for bioreactors,
consumables and factory automation and will be among the largest single-use
bioproduction capacities at a CDMO. The investment will also allow for further
expansion in the future. Approximately 80 new technical jobs are expected to be
added.
"Biologics have the potential to benefit
millions of patients around the world," said Michel Lagarde, president of pharma
services for Thermo Fisher. "Patheon Biologics, with this expansion, will be
better equipped to meet the needs of our customers and ultimately the patients
who rely on these life-saving therapies."
The Patheon Biologics Network of four global
sites is growing rapidly and has standardized on the 2000L, single-use platform
as the preferred option in new drug development through to commercialization.
The St. Louis site currently provides process development, clinical cGMP
manufacturing and commercial manufacturing using both fed batch and perfusion
processes and has in-house analytical capabilities for Quality Assurance and
Quality Control.
"Thermo Fisher's investment in the Patheon
Biologics Network is a recognition of the extremely strong growth in demand for
outsourced biologic development and commercial manufacturing," said Stephen Lam,
head of Biologics. "This expansion is a tangible demonstration of the company's
commitment to excellence in our biologics capabilities and to maintaining a
leadership position. Over the past two years, we have doubled our manufacturing
capacity at all of our locations including the St. Louis site – to meet our
customers' growing demand.
Mayne Pharma Opens Oral Solid Dose Facility
The 126,000 sq. ft. facility quadruples Mayne
Pharma's capacity to manufacture oral solid-dose pharmaceuticals in the US.
Mayne Pharma has officially opened its new
$80 million, oral solid-dose commercial manufacturing facility in Greenville,
NC.
Custom-designed from the ground up and under
construction for two years, Mayne Pharma's new 126,000 sq. ft. facility
leverages best-in-class containment design to meet or exceed the quality and
safety standards of major drug regulatory authorities.
The new facility more than quadruples the
company's capacity to manufacture oral solid-dose pharmaceutical products in the
U.S. to well over 1 billion doses, and introduces significant capacity to
manufacture potent compounds and new capability to manufacture modified-release
bead/pellet products.
Mayne Pharma's CEO Scott Richards said, "This
new Greenville facility will greatly enhance our internal capacity and
capability to support the mid- to long-term growth potential we see for our
business and allows us to manufacture in the U.S. advanced drug-delivery
technologies that until today were only available in our Australian facility"
He added, “The new plant will enable us to better control our supply
chain, serve our customers better and reduce product costs. In the next few
years, Mayne Pharma expects to introduce more than 20 products and double its
manufacturing volumes in the Greenville site, driven by the pipeline of products
under development, the transfer in-house of several products currently
manufactured by third parties, and by providing our Metrics Contract Services
clients with commercial contract manufacturing services.
"Mayne Pharma has a proven track record of
success with technology transfers and product launches. This year, Mayne Pharma
completed the technology transfer of disopyramide capsules from a Teva site to
Greenville, and launched two new products manufactured at Greenville-amiodarone
tablets and doxycycline hyclate immediate-release capsules."
With this new facility, Mayne Pharma
introduces commercial-scale, solvent-capable, fluid-bed processing and film
coating-a first for its operations in the U.S. Fluid-bed processing, also called
multi-particulate or bead coating, applies polymers to an active pharmaceutical
ingredient (API). Using this advanced drug-delivery technology, scientists can
modify how a drug is released after ingestion, such as delaying or sustaining
its release to reduce side effects or make the drug more effective.
Specifically designed for containment, the
new facility can readily manage the commercial-scale manufacturing of potent
compounds-a key growth area for pharma companies today as they develop
increasingly complex drugs for the treatment of cancer and chronic diseases.
Each of the 13 production suites in the new facility was engineered to meet
today's stringent manufacturing demands for mitigating cross contamination-while
also offering flexible space and delivering a broad range of capabilities and
services. Key features include:
Single-pass air and multiple distinct and
strategically placed airlocks for gowning, material and equipment;
Segregated product corridors;
100-percent HEPA-in and HEPA-out filtered
air;
Dedicated quality control laboratories; and
Commercial scale up to 450kg per batch.
The facility enables Metrics Contract
Services-Mayne Pharma's contract development division-to offer clients a
comprehensive "concept to commercialization" solution under one FDA site
registration. Metrics Contract Services provides formulation development and
analytical chemistry testing services to more than 100 third-party clients. With
the ability to offer those clients downstream commercial manufacturing services,
Metrics Contract Services can deliver larger scale and increased capabilities
for seamless scale-up, and reduce or eliminate the need for site transfers.
While commercial manufacturing is a new
offering for clients of Metrics Contract Services, it is not a new capability
for the Mayne Pharma team at the Greenville site. The Greenville site has
successfully tested, manufactured and packaged commercial products for more than
10 years. Space constraints in the former manufacturing facility precluded
Metrics Contract Services from broadly offering commercial manufacturing
services to its clients.
Now that commercial manufacturing has been
consolidated within the new facility, Mayne Pharma's former manufacturing
facility in Greenville will be repurposed during the next two years to expand
pre-commercial product development capacity to serve both internal research and
development and Metrics Contract Services clients. The repurposing includes the
creation of 10+ new processing rooms and expanded laboratories.
REST OF WORLD
Telstar Wins Baccinex Design and Build
Contract
Pharma CMO has
awarded Telstar the design and build contract for an aseptic filling process
plant in Switzerland.
Baccinex, a
full-service pharmaceutical contract manufacturing organization (CMO) that
specializes in the fill and finish of sterile lyophilized or liquid dosage
forms, has entrusted Telstar with the design and construction of a cleanroom
installation to accommodate an aseptic and lyophilized filling process line. The
project expands Baccinex’s existing manufacturing plant in the Switzerland
region of Jura near France.
The new
building, which will be completed in 2019, includes approximately 10,760 sq. ft.
(1000 m2)
devoted to the production of sterile pharmaceutical batches for clinical trials.
The turnkey project, equipped with a fully automatic aseptic filling line,
comprises a vial washing machine connected to a depyrogenation and sterilization
tunnel, and a vial filling machine — operating under laminar flow — that’s
equipped with a restricted access barrier system (oRABS).
Vials are
transferred to two freeze-dryers with automatic loading systems via a conveyor
belt; a subsequent capping machine completes the packaging process. There is
also an option for both non-lyophilized products and products requiring terminal
sterilization to be manufactured, providing improved versatility.
The aseptic area
integrates a number of auxiliary manufacturing processes, including raw material
dispensing, compounding, washing and preparation for the sterilization process.
The state-of-the-art plant design derives from specific requirements to
implement oRABS isolation technology and minimize the risk of product
contamination.
The scope of the
project involves conceptual, basic and detailed engineering, the construction of
a new manufacturing area and the provision of pharmaceutical production
equipment — almost entirely designed and manufactured by Telstar. It also covers
cleanroom architecture, an HVAC system fitted with integrated decontamination
technology, critical utilities (highly purified water, water-for-injection
[WFI], pure steam and nitrogen gas), non-critical utilities (compressed air,
softened water, chilled and hot water, industrial steam), electricity and the
entire automation system, which controls the HVAC process, decontamination and
particle monitoring system, among others. The new plant will also be fitted with
two liquid nitrogen freeze-dryers with automatic vial loading and unloading
systems — operating under laminar flow oRABS — and two autoclaves used for
material sterilization and, when required, terminal product sterilization.
Ten items of
containment equipment have been purchased, including weighing booths,
pass-through boxes with an integrated biological disinfection system, and
laminar air flow cabinets.
Telstar will
also perform and manage the validation process, including risk analysis, design
qualification (DQ), commissioning, installation qualification (IQ), operation
qualification (OP) and performance qualification (PQ), as well as providing
support services for quality assurance.
The company, a
specialist in the development of aseptic manufacturing facilities, undertook
both the design and complete execution of the project, from concept to final
validation, as well as supplying equipment that has been designed and
manufactured using in-house technology.
Having completed
the engineering, design and equipment definition phases in May 2017, the project
was awarded in July 2017 and is expected to be completed during the first
quarter of 2019.
Taking GMP
compliance and the latest industry trends into account, the design of the new
plant benefits from integrated energy efficiency systems that both generate
power and save money. And, prompted by the newly revised European Pharmacopoeia
monograph 169 on WFI, which, since 1 April 2017, allows water to be obtained by
non-distillation methods, Telstar has implemented a WFI generation system that
uses reverse osmosis and ultrafiltration in the new plant. The facility can also
product WFI by distillation when and if required.
Cherwell Laboratories Completes
Transition to ISO9001:2015
Cherwell
Laboratories, UK-based manufacturer of Redipor prepared media and supplier of
environmental monitoring solutions, has successfully completed the migration of
its quality management system to the new ISO9001:2015 version. This enhancement
affirms that Cherwell is operating to stringent quality assurance and
manufacturing standards, enabling its pharmaceutical customers to have complete
confidence in the company’s range of cleanroom microbiology products.
The British
Standards Institute (BSI) assessed the quality management system at Cherwell
during two surveillance visits in November 2017 and May 2018, raising only two
very minor issues that required attention and which were addressed rapidly.
Managing
Director at Cherwell, Andy Whittard commented, “Our business has always been
focused on delivering high quality products for our customers. We were keen to
ensure that the new version of ISO9001 helped us improve our systems and
therefore our offering to our customers. Our experienced in-house quality team
have spent the past 18 months working on this project ensuring we attain value
from the process.”
Cherwell’s
clients are mainly within the pharmaceutical sector, operating to the rigorous
standards laid out in Good Manufacturing Practice (GMP). These customers demand
high quality and as such any supplier must have robust procedures and processes
in place. The 2015 version of ISO9001 quality management places greater emphasis
on the leadership of the business and risk assessment to understand issues that
could affect the business.
Steven Brimble,
Quality Manager at Cherwell added, “The quality team at Cherwell were keen to
ensure not only a smooth transition to the new standard, but also to seek
improvements in our current procedures. Along with the deployment of Q-Pulse to
manage complaints; audit findings; non-conformities and document control; our
enhanced quality management system provides a sound basis for Cherwell going
forward.”
Cherwell’s
product offering includes the Redipor range of prepared media which it has been
manufacturing at its Bicester facility for over 30 years. Developed to service
industrial markets, the range offers flexibility, reliability and choice for
users and includes a selection of petri dishes, settle plates, bottled media,
injection vials and DIN bottles, broth bags and ampoules. Cherwell has a strong
understanding of users’ needs and an ability to offer bespoke products as a
solution to help resolve issues.
Tudertechnica Builds
Cleanroom for Silicone Hose
Italy's hose
manufacturer Tudertechnica has announced a US$8 million investment to add 40,000
sq. ft. to its factory in Padua. The project includes a cleanroom for silicone
hose.
The expansion
centers on adding 20,000 sq. ft. cleanroom that will be used to produce silicone
hose for the pharmaceutical, cosmetics and food industries.
The addition
will bring the total space at the Italian facility to about 100,000 sq. ft.
Andrea
Deregibus, general manager and CEO, has said the cleanroom will be built to ISO
8 classification and that the remaining space will be available for future
expansion plans.
With
construction scheduled for completion by the end of June, Tudertechnica expects
that the cleanroom and machinery to be installed around the beginning of October
to allow full production to start by the end of the year.
Tudertechnica
will have the capability to produce 130-foot long hose in the cleanroom, much
longer than the current industry standard of about 20 ft.
The expansion
plan is part of Tudertechnica's five-year strategy.
According to
Deregibus, the three target markets the company serves have trends calling for
more safety in its products. The company also estimates that the food industry,
in particular, will be in need of more silicone hose in the coming years.
Tudertechnica
will market these hoses through its distribution channels, for which it is
seeking suitable partners to join.
"We need someone
who is professionally prepared, with very good skills in silicone and the
application in order to sell our solution in the correct way, which is a really
high level," Andrea Compostella, marketing and sales manager, said. "We believe
this is the way that will bring us more results. It also gives the opportunity
to the distributor to have a stronger relationship with the end user, who will
decide to start with this new solution."
Tudertechnica
has started this process, identifying some prospective candidates in Europe, and
will continue with this in North America, Asia and other parts of the world.
In recent years,
Tudertechnica has seen growth with silicone and rubber-covered PTFE hoses with
volumes more or less doubling every two years.
Deregibus said,
"This is the right moment. The investment must be made when the market is up to
be ready to take opportunities for the future."
Tudertechnica
expects to add some new products to the PTFE lines by the end of the year.
Deregibus said the new portfolio will have "immediate impact on the market".
In line with
Tudertechica's strategy for growth the company is set to focus on the North
American, European and Chinese markets.
Currently, 20%
of sales for Tudertechnica come from Italy. Other parts of Europe account for
40%. Deregibus projected sales for 2018 will be closer to US$23 million.
Sanofi Expands R&D in
China with Chengdu Hub
Sanofi will
support development of polypeptides, gene therapy, monoclonal antibodies and
multi-specific antibodies through the expansion of its R&D plant in Chengdu,
Sichuan province, China.
Sanofi China
said it would invest €66m ($77m) in an R&D site to focus on digitalization and
big data analysis of clinical trial data, in Chengdu, Sichuan province. The
Chengdu Hub site will manage clinical trial data and files for Sanofi’s
pipeline, which targets therapeutic areas including diabetes and cardiovascular
diseases, oncology, vaccines, and rare diseases.
According to the
French drugmaker, “the Hub will accelerate the availability of trial results,
from Phase I to Phase IV…[and] leverage global cutting-edge biological
technology for polypeptides, gene therapy, monoclonal antibodies and
multi-specific antibodies.”
Sanofi plans to
employ approximately 300 local R&D experts at the site over the next 18 months.
The Chengdu Hub
will join Sanofi’s Asia-Pacific R&D Centre in Shanghai – which opened its doors
in 2010 – and 11 regional offices across the firm’s growing Chinese network.
China is the
‘third pillar’ of Sanofi’s global clinical sciences and operations, after France
and the US, the firm said in a statement.
"Our goal is to
link China's innovative achievements with the global ecosystem and develop
innovative drugs in China that could benefit patients around the world," global
head of Sanofi R&D operations Zhang Ji added.
Tot Biopharm
Launches Mab Manufacturing Plant in China
Tot Biopharm has
opened its second monoclonal antibody (mAb) production plant in Suzhou
Industrial Park, China.
The Chinese
biopharmaceutical company has launched a 16,000L capacity mAb production site
with upstream R&D, pilot-scale, clinical, and commercial production facilities.
Tot Biopharm
will also use the 139,880 sq. ft. (13,000m² plant )– which houses lyophilization
capabilities for antibody-drug conjugates (ADCs) – for commercial-scale
production of both biologic and small molecule drugs.
The company
initiated construction in 2016 in response to growing demand for oncology
drugs. The firm planned to install disposable bioreactors and processing systems
to build five production lines with a cell culture capacity of 2,000L.
The firm’s
specialized cancer drug production plant, including a 500L biologic pilot plant,
a BSL-2 certified viral facility, an OEL-5 isolator for ADCs, and a small
molecule site, was completed in 2012.
The new mAb
facility joins a growing number of antibody production plants in China.
Germany-headquartered Boehringer-Ingelheim launched its mammalian cell culture
facility in Pudong, Shanghai last year, and in January announced it had made
its first commercial mAb – BeiGene’s tislelizumab – at the facility.
Boehringer
Ingelheim Consolidates with Biologics Centre
Boehringer
Ingelheim says Germany-based biologics development facility will support both
its research pipeline and contract manufacturing business.
Boehringer
Ingelheim has announced plans to invest €230m ($269m) in a Biologics Development
Centre (BDC) at its R&D site in Biberach, Germany. The facility – set to launch
in 2020 – will house analytical, process development, and manufacturing
capabilities for biologics.
According to the
Germany-headquartered firm, the site will ‘free up’ capacity for its contract
manufacturing business: “In the BDC we will conduct development for biologics
from both our research pipeline as well as biopharmaceutical contract
manufacturing,” said spokesperson Matthias Reinig.
“As overall
development capacity will increase, more resources overall can be dedicated to
contract manufacturing development,” he added.
The BDC will
bring development activities – currently “spread over various places” at
Biberach – together, Reinig explained: “With the BDC, they will locate under one
roof while adding another 100 staff to further extend capacity.”
The investment
is the latest in a series of biopharmaceutical facility expansions for
Boehringer Ingelheim. In 2017, the firm broke ground on a €700m mammalian cell
culture production plant in Vienna, Austria, and opened a contract
biomanufacturing plant in Shanghai, China.
In addition, in
July 2017, the firm announced plans to expand, upgrade, and increase headcount
at its biologics manufacturing facility in Fremont, California.
Umicore API Facility Passes
cGMP Audit
The plant
manufactures four oncology APIs produced for global markets according to the
latest international guideline
Umicore’s Active
Pharmaceutical Ingredients facility in Pilar, Buenos Aires, successfully passed
its second cGMP audit by the US Food and Drug Administration.
The Auditor
acknowledged that both the production area and the associated documentation were
well maintained, rewarding Umicore’s constant focus on the quality of its
production processes and systems.
Umicore
manufactures in Pilar cisplatin, carboplatin, oxaliplatin and arsenic trioxide:
four oncology APIs produced for global markets according to the latest
international guidelines. It additionally exclusively manufactures a few high
potency APIs under customer contracts. The facility in Pilar opened in 2009 and
offers high quality products, professional services – such as exclusive
development and synthesis and regulatory support or IP management and strategy.
CellGenix, a
global manufacturing leader of GMP-grade raw materials for cell therapy, gene
therapy and tissue-engineered products, successfully completed the first phase
of its headquarters’ expansion as more customers approach late-stage clinical
development and commercialization.
In a first step,
the company added additional space to its headquarters in Freiburg, Germany.
Quality control, research and development laboratories as well as logistics and
warehouse space have already been put into operation.
As the next step, a state-of-the-art, automated filling and freeze-drying
line will be implemented in the existing GMP facility increasing finished
product capacity for recombinant proteins by more than tenfold. This second
phase of expansion is expected to be completed in the spring of 2019.
Positive
clinical data, a supportive financing climate and clearer regulatory
requirements have led to a strong growth in the cell and gene therapy space.
This is predicted to persist. The building extension allows CellGenix to
continue meeting the increasing demands for GMP-grade raw materials as more and
more promising cell and gene therapies approach market authorization and
commercialization.
“We are really
excited about our new facility and the additional flexibility it provides. It
supports our goal to become a key provider in the fight against disease, the
preferred supplier of raw materials and tools and trusted partner for large
scale manufacturing in the cell, gene therapy and regenerative medicine space.
The expansion of our facility is a result of the robust, sustainable and
profitable growth we achieved over the last years,” says Prof. Dr. Felicia
Rosenthal, chief executive officer of CellGenix.
WuXi Biologics Expands
with ADC Build in China
WuXi Biologics
has started building its antibody-drug conjugate (ADC) center in Wuxi City,
China, where it will offer biologics conjugate services for clients.
Chinese contract
development and manufacturing organization (CDMO) WuXi Biologics has initiated
construction of a 645,600 sq. ft. (60,000 square meter) ADC solution center near
Shanghai, China.
ADCs are
composed on an antibody linked to an active cytotoxic payload. Traditionally,
ADCs have been used to target and kill cancer cells, but are also being
developed to target antimicrobial and anti-inflammatory targets.
The $20m
(€17.2m) facility – first announced in December 2017 – will offer services from
"concept to commercialization" for biologics conjugates, including ADCs and
other protein conjugates, when it opens next year.
According to the
firm, the site will become a "world-class" ADC research and development and
manufacturing platform, which aims meet US, EU and Chinese current good
manufacturing practice (cGMP) standards.
“In
collaboration with chemistry division of WuXi AppTec Group, WuXi Biologics is
one of the few global companies that can provide the one-stop service to global
partners for antibodies, small molecule payloads, ADC drug substance and drug
products,” CEO Chris Chen said in a statement.
The center will
join WuXi Biologics’ single-use mammalian cell culture site, monoclonal
antibody (mAb) continuous process laboratory, and WuXi AppTec’s antibody
discovery and development laboratory in Wuxi city.
Earlier this
year, WuXi Biologics announced plans to expand manufacturing for clinical and
commercial production in Northern China, Ireland, Singapore, and the US.
Investment in Scotland to
Strengthen the UK’s Place in the Global Pharma Industry
A new £56
million UK innovation center, which will revolutionize how medicines are
manufactured, is to be located in Renfrewshire.
Protecting
future generations by bringing new medicines to market safely and quickly is one
of the biggest health challenges facing the world today.
A world-first,
the new industry-led Medicines Manufacturing Innovation Centre (MMIC) will offer
pharma companies, from start-ups through to multinational organizations, a
unique service to develop and adopt novel manufacturing techniques to adapt into
their own manufacturing processes. By transforming processes and technologies,
the speed of bringing new drugs to market could improve drastically.
With a global
market worth £98 billion, this investment will help put the UK, and Scotland, at
the forefront of technology and innovation in small molecule pharmaceutical and
fine chemical manufacturing which still makes up the bulk of how new medicines
are made. The pharmaceutical sector in Scotland employs 5000 people directly and
supports a further 16,500 jobs.
Supported by
Scottish Enterprise (£15 million), UK Research and Innovation, through Innovate
UK (£13 million) GSK and AstraZeneca (£7 million each), the MMIC is one of the
early projects across the UK to receive funding from the UK’s Industrial
Strategy Challenge Fund.
Benefiting
companies right across the UK, industry has played a key role in shaping and
developing the MMIC to ensure its success.
The new center
will be positioned next to the £65 million National Manufacturing Institute for
Scotland (NMIS) and at the heart of an Advanced Manufacturing Innovation
District. The MMIC aims to attract over £80 million of R&D investment by 2028
and will create 80 high value jobs directly by 2023. Up to 90 jobs will also be
created or retained in companies involved in the design and build phase and
post-construction.
Indirect
employment will be generated through start-ups, SMEs and large companies that
will grow their businesses using the transformative manufacturing technologies
developed within the MMIC.
Scottish
Government Minister for Business, Innovation and Energy, Paul Wheelhouse, said:
“I am delighted that the Medicines Manufacturing Innovation Centre (MMIC) will
be located in Scotland, given its potential to become a global center of
excellence and bringing significant benefits to Scotland’s economy. The location
of the MMIC is also a very positive endorsement of Scotland’s Life and Chemical
Science sectors and will build on our internationally recognized strengths in
both Research and Development and manufacturing.
“Scottish
Enterprise, on behalf of Scottish Ministers, is investing £15 million in the
MMIC helping to fulfill the vision of Scotland’s Life Sciences Strategy. This
will help to make Scotland the location of choice for the life sciences
community and help us grow the industry’s contribution to the Scottish Economy
by 90%, to £8 billion by 2025.
“As well as
helping to attract further manufacturing investment to Scotland, the Centre will
also be well placed to support new business start-ups and spin-outs and enable
established life and chemical science companies to profit from innovation.
“Whilst the
Centre will be located within the Advanced Manufacturing and Innovation District
in Renfrewshire, alongside the National Manufacturing Institute for Scotland, we
are taking a range of steps to ensure that the Sector across the whole of
Scotland is able to benefit from the project.”
UK Government
Minister, Lord Duncan, added: “This is great news for the UK’s Life Sciences
sector and especially important for Scotland in re-enforcing its global
reputation as a center for cutting edge scientific endeavor. We need more new
medicines to tackle deadly diseases more quickly and through our modern
Industrial Strategy we want to see more of this world leading research and
manufacture done here in the UK, bringing highly skills jobs and greater
prosperity with it. The UK Government has provided significant backing to this
project, with UK Research and Innovation investing £13 million through the
Industrial Strategy Challenge Fund.”
Linda Hanna,
Managing Director at Scottish Enterprise, said: “We are delighted to welcome the
new MMIC to Scotland. There is no other facility like this in the world and is a
fantastic endorsement of Scotland as an ideal place to invest in global
excellence in high value manufacturing drawing on our skills, innovative
companies and academic expertise.
“Industry
leadership and co-investment has been central to shaping this center and will
remain at the heart of what makes it a success, providing a platform for
companies right across the UK to collaborate, innovate and develop world-leading
medicine manufacturing processes and technologies.”
Ian Campbell,
Innovate UK Interim Executive Chair, said: “This is a fantastic investment for
the UK, and especially for Scotland, as we look to place cutting-edge innovation
at the heart of tackling some of society’s greatest 21st century challenges.
“UK Research and
Innovation is leading the charge to bring the UK government’s modern Industrial
Strategy to life – translating research into commercial success, building on our
industrial strengths and sustaining economic prosperity across our communities.
Our job at Innovate UK, working within the UK Research and Innovation family, is
to help good ideas become great businesses delivering products and services
which change lives for the better.
“The new MMIC
promises to enhance Scotland’s reputation as a trusted center for high value
manufacturing, while transforming the UK’s standing within the global
pharmaceutical industry.”
Dr Dave Tudor,
Chair of the Scottish Life Sciences Industry Leadership Group, and Vice
President, Head of Global Manufacturing and Supply Strategy for GSK, said:
“Industry, government, academia and others are working together to secure an
internationally competitive leadership position for the UK in life sciences for
the long-term. GSK has long advocated the value of collaborations like the
Medicines Manufacturing Innovation Centre to capitalize on our world-class
science base and deliver innovation that drives growth and improves patient
care. As the UK’s largest life sciences company and one of its biggest investors
in research, we are delighted to have an active involvement in this new Centre.”
Andy Evans,
Chair of the Medicines Manufacturing Industry Partnership (MMIP) and Head of
Macclesfield Site for AstraZeneca, said: “The UK must remain a globally
attractive and competitive location for advanced medicines manufacturing as this
is key element in our economy making a very significant contribution to our
exports. Enabling the growth of medicines manufacturing is hence a key part of a
successful Life Sciences Industrial Strategy and the MMIP is pleased to see this
combined investment between Business and Government in manufacturing innovation.
“For
AstraZeneca, our research activities in Cambridge are complemented by our strong
presence in the North West of England which is a location for innovation, where
our development scientists’ partner with experts in high-tech manufacturing to
turn molecules into new medicines. We are very pleased to be a founding partner
in the new MMIC, along with others across industry and the Scottish and UK
governments. Our ambition is for patients worldwide to benefit from the
accelerated adoption of emerging and novel medicine manufacturing technologies
developed in the UK.”
The MMIC will be
led by the Centre for Process Innovation (CPI) in partnership with the
University of Strathclyde’s Centre for Continuous Manufacturing and
Crystallization (CMAC) and the Medicines Manufacturing Industry Partnership
(MMIP).
Nigel Perry MBE
FREng, Chief Executive Officer at CPI, said: "The Medicines Manufacturing
Innovation Centre will enhance the UK’s existing competitive advantage by
deepening the skills base and strengthening the rationale for companies to
invest in new, highly productive medicines manufacturing.
“CPI is
delighted to be working alongside the University of Strathclyde, Innovate UK,
Scottish Government and our industry partners to deliver this globally unique
center that will prepare the pharmaceutical supply chain for vital, next
generation medicines and further extend CPI’s healthcare capabilities.”
Professor Sir
Jim McDonald, Principal of the University of Strathclyde, said: “Strathclyde has
earned an international reputation for research and innovation that accelerates
and enhances the manufacturing of medicines and pharmaceuticals. As strategic
partners in MMIC, we will have an enhanced role in supporting industry to
deliver urgently-needed medicines both swiftly and effectively. The challenges
of health are among the biggest facing today’s world; they are changing rapidly
and continually and medicine must keep pace with them to provide solutions. MMIC
will provide world-class talent, research capability, technology, facilities,
knowledge and experience to industry to ensure these challenges are met.”
Mike Thompson,
CEO of the Association of British Pharmaceutical Industry (ABPI), said: “This is
a strong signal of intent from Government and the pharmaceutical industry that
they are ready to get behind the UK as a global leader in medicines
manufacturing.
“Medicines
manufacturing is no longer the siloed, labor intensive process of yesteryear.
This cutting edge center instead provides a unique space for academics, research
scientists and manufacturing partners to work side by side designing new ways to
transition the medicines of the future out of development and in to the supply
chain.
“Global
pharmaceutical companies are already excited about UK science, our world leading
Universities and unique research centers and this facility means we now have a
manufacturing innovation site to rival anything in the world.”
Steve Bates, CEO
of the Bioindustry Association (BIA), added: “Improving productivity in drug
development is vital to economic innovation for our sector. Enabling that to
happen in the UK gives us competitive advantage and is a good example of joined
up industrial strategy in action.”
Carleton University Health Sciences Building, Ottawa, Ontario, Canada
Cost: $52
million CAD (about $40.3 million USD)
Size: 132,000
gsf; includes 30,000 sf of research laboratories and support; 10,000 sf of
teaching labs and support; a 13,500-sf vivarium
Project team:
NXL Architects (research area and vivarium architect); Montgomery Sisam
Architects Inc. (lead architect)
Carleton
University’s Health Sciences Building broke ground in October 2015 and
co-locates two rapidly growing university programs. With seven floors divided
between the University’s newly formed Health Sciences department and existing
Neuroscience Program, the design and layout of the labs, offices and workspace
help to encourage and facilitate collaborative interaction between faculty and
students.
This new-build
facility includes modular laboratories for teaching and research, vivarium,
electronic and interactive classrooms; four lecture theatres; a student resource
center; informal student study and social spaces; offices and public assembly
space. The interior was also designed to allow for future program growth, while
accommodating changing research needs.
The design of
this facility incorporates a scalable utility distribution strategy, stacked in
a sidehouse concept, which replaces the traditional penthouse, thereby enabling
utilities to feed into the building horizontally. This breakthrough in utility
strategies has also allowed the vivarium to be located on an upper level,
gaining access to ample natural light while remaining isolated from vibration
and noise-producing air handling and related equipment (reciprocating chillers,
air handlers, compressors, etc.) thanks to a segregated structure. The top
floors incorporate a double height sidehouse which stacks the air handlers on
top of each other, with internal service stairs and catwalks to provide access
to all high-level equipment; while ceiling voids provide access above the
vivarium space where required. The sidehouse allows utilities to be right-sized
for the program they are supporting, or changed to accommodate new program
areas. With all of the equipment within the sidehouse the labs, support, offices
and open workspaces can connect in a much more dynamic environment.
The new Carleton
Health Sciences building includes the latest technology in high-quality
undergraduate teaching labs, providing greater access to experiential learning
opportunities for students while encouraging interdisciplinary collaboration and
closer interactions within departments.
Completion date:
several floors are currently operational, with an official opening expected in
mid-2018
Juniper Pharma Services
Expands Lab Facilities
Juniper Pharma
Services, a contract development and manufacturing organization (CDMO)
specializing in the development of challenging small molecules, has announced a
significant expansion to its UK-based drug development and clinical trial
manufacturing facilities.
The extension
provides four additional process development laboratories at its Nottingham
site, improving the output and efficiency of its development and clinical
manufacturing operations.
Set to be fully
operational by summer 2018, the new laboratory space will allow Juniper to work
with a growing client base to transform poorly soluble and difficult to
formulate molecules into successful products. The expansion will ensure that
processing and formulation work is scalable, enabling the efficient manufacture
of stability and clinical batches.
The expansion
demonstrates Juniper Pharma Services' growth in the drug development arena and
its increasing commitment to solving tough formulation challenges. The new
facilities, combined with its long-standing expertise in drug formulation
development, is desirable to many pharmaceutical clients and enhances the
company's reputation as a leading CDMO in the UK and globally.
Nikin Patel,
president at Juniper Pharma Services, said, "We are always exploring
opportunities to extend our service offerings to meet the evolving requirements
of our market and clients. This facility expansion, which has significantly
increased Juniper Pharma Services' capacity, is the latest effort in this
endeavor."
Jansen Group Completes Interior Of Ultramodern Belgium Hospital
Following
several years of construction Jansen Group has officially opened the high-tech
AZ Sint-Maarten hospital, in Mechelen, Belgium.
“We turned the
empty building shell into a functional, ultramodern hospital,” said Nadia
Jansen, CEO of Jansen Group.
The Limburg,
Belgium-based construction company was responsible for the entire interior
finishing of this new hospital.
AZ Sint-Maarten
now has all of its healthcare facilities concentrated in one location. The
building is 1,129,800 sq. ft. (105,000 m2), has 654 beds
and accommodates 1700 staff.
According to
Peter Lowist, COO of Building Group Jansen, with this project and the
corresponding set-up of a number of cleanrooms - Jansen Group has reinforced its
position as an expert in the healthcare sector.
Lowist commented
that: “In a lot of the areas there are strict conditions with regard to hygiene,
airtightness, pressure differences, etc. The finishing of the hospital pharmacy
and the operating theatres deserve a special mention.”
“From ceilings,
floors and furniture to details such as handles, wall protection and floor mats.
In the building we used 150,000 m2 interior walls, 600,000 m2
plasterboard panels, 450,000 running meters of profiles, more than 6000 interior
doors and 525,000 screws. At peak times more than thirty carpenters were working
at the same time. Each piece of furniture – from a simple cabinet to the
complete fittings of the nursing stations - was drawn and fitted on the
construction site down to the last screw,” explained Lowist.
Jansen Group
worked in a joint venture together with construction company MBG, together with
architectural firm VK A&E. For the first time the trio implemented the
much-discussed Building Information Model (BIM) working method within a
large-scale project.
“With BIM a
number of construction partners work together in a clear 3D model. The partners
contribute continuously to the plan so that you as architect, building developer
or (sub)contractor are always working on an up-to-date version. Moreover, the
system indicates possible errors when parties want to set up conflicting
actions. By avoiding misunderstandings in advance digitally, you avoid errors on
site,” said Danny Jacobs, project manager, Jansen Group.
Zoetis’ Animal Vaccine Research
and Manufacturing Complex, Suzhou
In April 2018,
global animal health company Zoetis began constructing a new animal vaccine
manufacturing and research facility in Suzhou, China.
The new facility
will house a global manufacturing and supply facility, as well as a research and
development (R&D) center.
The project is
expected to be completed and awarded a certificate of good manufacturing
practices (GMP) from the Chinese Ministry of Agriculture by 2021. Once in
operation, it is also expected to generate more than 100 new jobs in R&D and
manufacturing.
The animal
vaccine manufacturing facility will be used for the development and production
of high-quality vaccines for livestock, fish and companion animals. The products
will be sold primarily in the Chinese animal health market.
The plant will
allow Zoetis to help livestock farmers in China meet the increasing domestic
demand for safe supply of pork, milk, beef and fish in large quantities. It will
become the company’s second manufacturing complex in the country, joining an
existing site in Jilin.
The vaccines
manufactured at the new facility will help safeguard animals from the strains of
infectious diseases.
The
state-of-the-art Suzhou vaccine research and manufacturing complex will be
developed in multiple phases. With a total of 462,680 sq. ft. (43,000m²), the
first phase will accommodate six main buildings for vaccine manufacturing and an
R&D laboratory.
The campus will
also include a production facility, a warehouse and a central utility building.
In addition, the
campus will be equipped with advanced technologies for the production of viral
and bacterial medicines and include a pilot-scale manufacturing facility for the
development of new vaccines.
Zoetis appointed
engineering design, architecture, project and construction management services
provider PM Group for the conceptual design and master planning of the new
complex, while Australian building construction services contractor Cockram will
assist in overall construction management.
China is one of
the world’s largest animal health markets, with reported $4.3bn of sales in 2017
and witnessing a compound annual growth rate between 7% and 10%. The growth was
primarily due to vaccines sales.
China also has
one of the world’s largest pig market and raises approximately 700 million hogs
a year.
In addition,
spending on pet medications and vaccines in 2017 exceeded $300m, and the pet
healthcare market and ownership in the country continues to grow.
Marketing
commentary on Zoetis:
Founded in 2013,
Zoetis is engaged in producing medicine and vaccinations for livestock farmers
and veterinarians. The company develops and manufactures a wide range of animal
health medicines and vaccines, diagnostic products, genetic tests and
biodevices.
Headquartered in
Parsippany, New Jersey, Zoetis operates in more than 45 countries. Its products
are sold in more than 100 countries worldwide.
Zoetis operates
a network of 25 manufacturing sites across 12 countries, with a workforce of
roughly 9,000. The company reported revenue of approximately $5.3bn in 2017.
Zoetis opened a
medicated feed additive products manufacturing facility in 2015 for the
production of water-soluble and pre-mix products, including Linco-Spectin®,
Lincomix®, Tilmicosin® and COT
(Check-O-Tox®).
Samsung
BioLogics’ Third Manufacturing Facility, Songdo
Samsung expects
to be the world leader in biopharmaceutical contract manufacturing with the
establishment of a new facility in Songdo, Korea.
The new facility
will be operational in the fourth quarter of 2018.
On 21 December
2015, Samsung BioLogics began constructing its third plant in Songdo, South
Korea.
The new plant is
expected to make the Samsung Group one of the world’s largest biologics contract
manufacturing operators (CMO) in the world.
The company
planned to invest KRW850bn ($721m) to build the biopharmaceutical manufacturing
facility. Construction was completed in November 2017 and operations are
scheduled to start in Q4 2018.
In February
2018, Samsung BioLogics received its first manufacturing contract for the plant,
which is worth $148m.
The facility is
being built in the Incheon Free Economic Zone (IFEZ), which comprises the Songdo
and Cheongna regions, as well as Yeongjong Island. The country’s west coast
originates at IFEZ and serves as a gateway to Seoul and a metropolitan area of
central Korea.
The new plant is
designed to have an annual production capacity of approximately 180,000l, which
will increase Samsung BioLogics’ total production capacity to 360,000l a year
when fully operational.
Annual sales and
operating profits are expected to reach KRW2tn and KWR1tn respectively after
full completion of the plant.
The new facility
will supply biopharmaceutical products to meet growing manufacturing demands
from global pharmaceutical companies. It will operate throughout the year and
offer services to clients, including small-scale batches for clinical trials to
supplying large-scale batches for commercial production.
The number of
pharmaceutical products the company will produce is estimated to be 350 by 2020.
Samsung
BioLogics has two large-scale facilities located in Incheon, which offer a wide
range of solutions in biologics development and manufacturing.
Samsung
BioLogics’ biopharmaceutical portfolio:
Samsung
BioLogics is a contract manufacturing operator that produces biopharmaceutical
products for established brands such as Bristol-Myers Squibb and Roche. It was
established by Samsung Electronics, Samsung Everland, Samsung C&T and Quintiles
Transnational.
The company
entered a ten-year contract with Bristol-Myers Squibb for manufacturing a
commercial antibody cancer drug at its new plant.
Samsung
BioLogics already has two plants in the Incheon zone. The first plant received
production approval from the US Food and Drug Administration (FDA) for the
manufacture of biologics drug substances in November 2015 and European Medicines
Agency (EMA) in July 2016 monoclonal antibody drug substances, while the second
plant received FDA and EMA approvals for the first monoclonal antibody drug
substance in October 2017 and December 2017, respectively.
Samsung
BioLogics aims to increase the global pharmaceutical capability through its
fully integrated production facility that offers process development, drug
substance manufacturing and fill and finish services at a single location.
Samsung’s first
plant accommodates six stainless steel bioreactors with an upstream capacity of
5,000l each and a total capacity of 30,000l. It is designed and built to carry
rapid high protein production.
It contains
suites for upstream, downstream, fill and finish units, as well as has an
administration building and a warehouse with long-term cold storage capacity.
The second plant
contains ten bioreactors with an upstream capacity of 15,000l each and a total
capacity of 150,000l.
Services such as
cell line generation, process and analytical method development and analytical
services are offered at Samsung’s facilities.
Other services
include clinical and commercial bulk current good manufacturing practice (cGMP)
manufacturing of drug substances and drug products with quality assurance,
quality control, regulatory compliance standards and support for customers.
Cambrex Expands in Italy and
Sweden
Cambrex’s news
that it will be constructing a research and development laboratory at its
Italy-based site follows on the heels of its recently announced plans to begin a
$5m expansion in Sweden.
According to the
contract development and manufacturing organization (CDMO), the expansion at the
site in Italy also will include the recruitment of additional scientists “to
increase the number of generic active pharmaceutical ingredient (API) in the
company’s development portfolio.”
The new 1,614
sq. ft. (150 square meter) research and development laboratory will include 14
fume hoods and combine both chemistry and analytical development capabilities.
Cambrex expects
building work to be completed by the end of 2018. Equipment installation and
validation will follow in Q1 2019.
$5m expansion at
Karlskoga, Sweden
Cambrex also
recently announced plans to commence a $5m expansion of its Karlskoga,
Sweden-based laboratory facilities. The investment will add capacity for process
development and scale up, handling of potent substances, crystallization
studies, and solid phase characterization.
Work on the new
6,456 sq. ft. (600 square meter) building will begin at the end of Q2 2018. It
is expected to be completed in Q2 2019.
According to the
company, the building will feature a new technical laboratory to support tech
transfer studies – for which the main challenge is the assessment of
scale-dependent process variables, explained Ingrid Hegbom Ekman, director of
research and development, Cambrex.
“Knowledge
transfer between R&D and production can also be a challenge as some observations
are more difficult to describe in words than others, and need to be experienced
together and discussed while the observation is taking place,” she said.
“The expansion
will facilitate experiments at a larger laboratory scale, in close collaboration
with receiving unit engineers, giving them first-hand experience of the
process,” she added.
After
construction has completed, Hegbom Ekman said future investments will focus on
equipment “that will allow in-line reaction monitoring and laboratory equipment
that mimics that in the plant.” To support this, Cambrex aims to invest in
crystallization and solid phase characterization and the equipment required, she
added.
Additionally,
the investment will enable potent substances handling at large laboratory
scales, as well as high-pressure reactions and parallel synthesis for API route
scouting and development. Two analytical development and quality control
laboratories and new office space also will be added to support 12 new hires –
taking Cambrex’s total employee count at the site to 60.
Cambrex Expands
Generic API R&D Capabilities
Cambrex has
unveiled plans to expand research and development capabilities at its site in
Paullo, Milan, Italy. The investment will be in the construction of a new 150
square meter R&D laboratory and the recruitment of additional scientists to
increase the number of generic APIs in the company's development portfolio.
The new
laboratory will include 14 fume hoods and will combine both chemistry and
analytical development capabilities, with the installation of glass lined
reactors, as well as analytical instruments including multiple high and
ultra-performance liquid chromatography, and gas chromatography systems. It is
estimated building work will be completed by the end of 2018, allowing
installation and validation of the analytical instruments to take place in the
first quarter of 2019.
"The generic API
industry is growing due to the continued expiry of product patents, which
results in the constant flow of new generic entrants to the market," said Aldo
Magnini, managing director, Cambrex Milan. "The new laboratory will increase the
number of programs we can be active in at any one time, allowing us to expand
our portfolio of generic products."
Cambrex
currently manufactures over 70 generic APIs which are produced to cGMP standards
and the Milan site comprises seven production departments, supported by a pilot
plant, kilo-scale plant and development and analytical laboratories.
Parker Details Investment Timeline,
Launches New Single-Use System
Parker
Bioscience outlines its planned investment to meet demand as the industry shifts
from traditional processes to biological – for which single-use products are
critical, says exec.
“Biopharmaceuticals now represent the major pipeline of blockbuster drugs for
the coming years,” said Mike Brailsford, general manager at Parker Bioscience.
“The move from traditional chemical-based processes for pharmaceutical
manufacture to biological processes has been growing for the past 15 years.”
Today, this
trend is now “fully established,” said Brailsford – a shift which has led to
global investment in new biopharmaceutical manufacturing facilities as well as
the conversion of existing facilities to biologic facilities.
“This move is
driving consistent double-digit growth in this market which is expected to
continue for the foreseeable future,” said Brailsford, noting that “single use
products are critical to this market as without this cleaning of equipment
between batches is very difficult to manage.”
The SciLog
SciPure FD System combines fully the automated bulk filtration and dispensing of
biopharmaceutical products with a shipping solution to safeguard product
integrity, according to the company.
The company
created a patent-pending bottle design that has been validated down to -89˚C
while undergoing a validated shipping study (ASTM D4169).
To meet
increasing demand for biopharmaceutical services, Parker Biosciences late last
month announced a multi-million dollar expansion at its UK-based site.
2018
The phased
investment program will see the addition of a new Class 7 cleanroom facility for
the manufacture of single-use assemblies used in biopharmaceutical
manufacturing.
“These
assemblies are supplied to biopharma customers fully assembled and sterilized
ready for direct use in their sterile clean room facilities in the manufacture
of drug products,” said Brailsford.
The expansion
also will include a new manufacturing area for single use sensing technologies,
which Brailsford explained allow users to monitor process parameters such as
temperature, pressure, and conductance.
In November of
this year, the company will complete office refurbishment for its expanding
workforce, which includes “a significant intake of younger employees into new
areas of the business and to support our business growth,” Brailsford said.
The quality
control (QC), research and scientific support laboratories also will be expanded
at this time. The facilities will provide capabilities including microbiology
testing, scanning electron microscopy, through to pilot scale facilities.
Additionally, a new facility for the development, manufacturing, and
commissioning of automated manufacturing systems will be added.
2019
To “meet the
demands of the growing business,” Parker will complete construction of a new
warehouse in early 2019, Brailsford explained.
By late 2019,
the existing cleanroom manufacturing area will be redeveloped and upgraded to
Class 8. The floor area available for manufacturing filter products also will be
expanded.
Wasdell Group Invests in
New Microbiological and Analytical Lab
New 1,200 sq.
ft. facility in Newcastle will support Wasdell's planned move into the
manufacture of sterile products later this year
UK's Wasdell
Group, the outsourcing partner to companies within the pharmaceutical, medical
device and clinical trials industries, is investing £500k in a new laboratory at
its site in Newcastle.
The
purpose-built 1,200 sq. ft. facility will allow Wasdell to offer in-house
microbiological and analytical services to its customers and will support the
business’ manufacturing, packaging and quality control (QC) teams.
The investment
follows on from a growing customer base as well as an increase in the number of
pre-clinical development projects that have recently been awarded to Wasdell.
Daniel Tedham,
MD at Wasdell, said: “This latest investment is part of a client-centric
strategy that ensures we continue to offer existing and new clients a fast and
efficient service that meets their end-to-end supply needs.
“We’ve seen a
notable increase in demand for analytical support from our existing clients and
the investment in our microbiological capabilities has been driven by our
planned move into the manufacture of sterile products later this year.”
The investment
is the first phase of the company’s ongoing expansion strategy to bolster its
laboratory capabilities and ensure seamless internal operations. The second
phase will include the opening of a new laboratory facility in Ireland to
futureproof Wasdell’s release testing offering for the European market in the
event of a hard Brexit.
A
microbiological laboratory team will deliver in-house environmental monitoring,
sample analysis, water testing, microbiological identification analysis,
component testing and growth promotion testing.
The lab will
also offer analytical capabilities for chemical, physical and microbiological
analysis including HPLC, FTIR and wet chemistry with QC testing of raw
materials, drug substances (currently Schedule III with capacity to cater for
Schedule II products) and drug products in accordance with pharmacopoeial
monographs and client methods.
The facility is
the latest addition to the company’s manufacturing site in Newcastle. The 26,000
sq. ft. facility is MHRA approved for pharmaceutical manufacturing and has a
Home Office Controlled Drugs license with onsite storage facilities.
It follows the
recent announcement of the company’s new €30m pharmaceutical facility in
Dundalk, Ireland, which will offer QC import testing, a variety of current and
novel packaging technologies as well as storage and distribution.
More on Cambrex New Lab Expansion
Cambrex Corp., a
manufacturer of small molecule innovator and generic APIs, began a $5 million
expansion of its lab facilities in Karlskoga, Sweden, to augment capability and
capacity for process development and scale up, handling of potent substances,
crystallization studies and solid phase characterization. Construction on the
600 m2 building is expected to be complete in 2Q19.
The expansion
will create space for a new technical lab with walk-in hoods for large scale lab
syntheses up to 10 liters, where engineers and chemists will undertake tech
transfer studies. The new investment will also enable handling of potent
substances at a large lab scale, high pressure reactions and parallel synthesis
for API route scouting and development.
In addition to
the technical lab, the expansion will feature two analytical development and
quality control labs and additional office space for 12 additional scientists
and chemists, bringing the total headcount to 60.
“We have a rich
history in chemistry at our Karlskoga site, dating back 120 years to Alfred
Nobel himself in 1896,” said Bjarne Sandberg, managing director, Cambrex
Karlskoga. “The new laboratory expansion will enhance our ability to provide
global customers with scientific and chemical excellence.”
In 2017 Cambrex
upgraded its continuous flow capabilities in Karlskoga with a dedicated
commercial-scale unit, capable of producing multiple metric tons of high purity
API intermediates per year. The company also completed the installation of
multiple continuous flow reactor platforms at its process development facility
in High Point, NC. This investment is focused on development of processes to
supply clinical as well as commercial demand for chemical syntheses.
Avara
Pharmaceutical Services Acquires Major Sterile Manufacturing Facility and
Development Center in Canada
Avara
Pharmaceutical Services, a world-class contract development and manufacturing
organization (CDMO), announced that it has agreed to acquire the largest sterile
manufacturing facility for injectable medicines in Canada from a leading global
pharmaceutical company, as part of a continuing expansion of its global
footprint.
"This
acquisition represents our first entry into the Canadian market and further
expands our sterile processing capability, which is in very high demand," said
Timothy C. Tyson, Avara's Chairman and Chief Executive Officer. "It comes with a
world-class development center and a dedicated team of experts that will support
us in delivering high-quality pharmaceuticals that meet or exceed customer
expectations and regulatory requirements."
The proposed
acquisition of Novartis Technical Operations' sterile manufacturing facility and
the adjacent Sandoz Development Center located on the Sandoz Canada campus in
Boucherville, Quebec, is expected to be finalized in the next few months,
following the completion of a number of closing conditions including receipt of
anti-trust approvals. It follows Avara's acquisition of another sterile facility
in the past year, one from Pfizer Inc. in Liscate, Italy, and one solid dose
manufacturing facility from GlaxoSmithKline in Aiken, South Carolina. It will
bring the number of manufacturing and development sites operated by Avara
worldwide to ten: two in Canada; three in the United States, including corporate
headquarters; one in Puerto Rico; one in the UK; one in Ireland; one in Italy;
and one in France.
The Boucherville
site is the biggest injectables production facility in Canada and provides a
number of strategic and lifesaving medicines to the Canadian healthcare system,
mostly hospitals. As part of the asset purchase agreement, the parties have
committed to sign a long-term supply contract to guarantee continuous supply of
products manufactured in Boucherville. No impact on jobs is anticipated at the
moment and Avara intends to invest in the site and pursue business development
opportunities to optimize the plant's utilization and expand its customer base.
"We look forward
to a seamless transition for employees, patients, customers, partners and other
stakeholders," added Mr. Tyson. "We are impressed by the know-how at the
Boucherville plant and Sandoz Development Center team and intend to leverage
their expertise to develop new opportunities in the contract pharmaceutical
market, in Canada and elsewhere."
About Avara:
Avara
Pharmaceutical Services, Inc., based in Norwalk, Connecticut is an international
pharmaceutical services company that delivers world-class contract manufacturing
and technical services to the pharmaceutical industry. Avara has primary and
secondary manufacturing facilities in North America and Europe and supplies
products to all major markets around the world. Avara's broad experience with
supply chain, commercialization, product launch and product transfer allow us to
sustain exemplary levels of product quality and regulatory compliance. The
company is known to exceed customer service level expectations and consistently
deliver on time, in full at a fair price.
McIlvaine Company
Northfield, IL 60093-2743
Tel:
847-784-0012; Fax:
847-784-0061
E-mail:
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Web
site:
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