august 07 update

McCarthy Building is finishing work on the $5 million renovation and expansion of UNLV's Shadow Lane Biomedical Facility on Charleston Boulevard in the heart of the city's medical district.

The University of Nevada, Las Vegas acquired an existing rehabilitation center from the state and turned it into a campus for the university's research and training in medical sciences and biotechnology.

The campus, designed by SmithGroup architect of Phoenix, provides classroom, laboratory and administrative office space for UNLV's expanding nursing and dental schools.

As part of the interior remodel, McCarthy transformed the 25,000-square-foot rehabilitation center into a 40,000-square-foot biomedical facility by pouring a 15,000-square-foot slab of concrete between the existing 23-foot ceiling and the floor.

The concrete work and use of a unique micropile column system allowed McCarthy to add a "midfloor" to the building, assistant superintendent Robert Bedsworth said.

The micropile system required four 30-millimeter diameter steel rods to be drilled 40 feet into the ground to support each column system. Once the micropiles were in place, a 4-foot hole was excavated around the rods to allow for the reinforcing of the pile cap.

The pile caps were then poured to support and distribute the load of the column. After they were reinforced and poured, the columns were ready to be formed and poured with concrete. One hundred twenty-four micropiles were drilled for 31 columns to support the floor.

AFI Partners Acquires, Renames OSG Norwich Pharmaceuticals

OSG Norwich Pharmaceuticals, a pharmaceutical outsourcing manufacturing and packaging provider, was recently purchased by AFI Partners, a private equity group based in New York, NY. The new company is known as Norwich Pharmaceuticals, Inc.

The terms of the deal were not disclosed. According to Christopher R. Calhoun, president of Norwich Pharmaceuticals, operations at OSG's Norwich, NY, facility will continue uninterrupted. The current leadership team will remain in place and will continue to manage the business. All current employees will also remain with the new company.

Since its inception in 2001, employment at the Norwich operation has increased 70%, from approximately 250 people in 2001, to the roughly 425 people presently. The company services the pharmaceutical industry exclusively, providing comprehensive support -- from clinical trials, through scale-up, to commercial launch -- to marketers of solid dose, semi-solid, and liquid pharmaceutical products. Company services include outsourced manufacturing, packaging, quality control and distribution.

The types of investments will initially revolve around the company's existing infrastructure, said Bob Calabro, Norwich's vice president of sales and marketing. "We will continue to invest in core technology and facilities to insure our competitiveness," he said. "For example, this year we will add Tote over press capability on our new Fette 2200 tablet press, new chiller capacity is being added, humidity control is being improved, and we are expanding/upgrading our laboratories. There will be additional investments in 2008."

Charles River to Build Preclinical Services Facility

Charles River Laboratories International has plans to build a new facility in Sherbrooke, Quebec, to support its preclinical services business. The new facility, which will be located in the company's newly constructed Sherbrooke Biomedical Park, will provide drug discovery and development services to the pharma/biopharma industries.

The new facility will be approximately 300,000 sq. ft., 25% of which will be constructed in a first phase that is scheduled to open in 1Q2009. Construction of the remaining phases will be based on market demand. The Sherbrooke facility will employ 1,000 people who will work with the staff of 1,600 currently located in the company's Montreal facility.

Catalent to Expand Production

Catalent Pharma Solutions, Inc. and ALK-Abello A/S have signed an agreement that will expand Zydis production capacity dedicated to ALK-Abello's immunotherapy products. Under the agreement, ALK-Abello will fund a new production line for current and future tablet-based allergy products, which will be based at Catalent's Swindon, UK facility. Commercial production on the new line is expected to begin in 2010.

ALK-Abello has launched Grazax, a tablet-based vaccine against grass pollen allergy, using Catalent's Zydis oral dissolving tablet technology, and Catalent is currently producing the Zydis formulation of Grazax in the Swindon facility.

Modular Unit for Hospital Pharmacy

A new aseptic pharmacy unit, built at St Georges Hospital NHS Trust in London, has been installed using modern modular construction techniques that help to maximize limited space.

The 408m2 (4,390 sq. ft.) unit has benefited from the expertise of construction specialist Clean Modules – a leader in the project management of cleanroom installations, controlled environments, clean-air and conditioning systems.

The site’s close proximity to hospital buildings made it difficult to employ traditional cleanroom building methods. As a result both the hospital trust and Clean Modules opted for the installation of a four-4 steel module set on a critical load bearing steel frame. This modular construction is said to provide a lightweight but rigid structure which can be prefabricated off-site and moved into position with little disruption to patients, staff, emergency services and public transport.

In the main command and preparation room and the GMP Grade D Aseptic Unit, which are 12.2m x 6.5m and 10.5m x 6.5m respectively, the rooms' widths are nearly double that which could have been achieved with a straightforward mobile building solution. This gave the pharmacy department space to install the latest grade A isolator technology in the form of nine Amercare and La Calhene isolator cabinets with Clarus hydrogen peroxide generators and rapid gassing ports.

The facility also features a grade D cytotoxic cleanroom suite, which contains three isolators for the preparation of cancer drugs specific to each patient and dedicated areas have been created to store, prepare, check and clean products.

Cook Pharmica Targets Growing Outsourcing in Biopharmaceutical Industry

When Cook Pharmica completed Project Phoenix, its $70 million contract biopharmaceutical services facility in Bloomington, Indiana in late 2006, its impressive construction schedule - 10 months versus the industry norm of 18-36 months - represented just one in an array of outstanding accomplishments.

From the outset, the project’s designers opted to use as much new technology as practicable. Flexible processing systems along with less stationary equipment (only the 2,500 L bioreactors of the harvest tanks are permanent) facilitated greater deployment of disposable technologies at the facility. The planners also established goals for a paperless system and integrated information technology (IT) platforms early in the process.

Customization between systems facilitated full integration with inventory management, document management, maintenance management, change management, equipment tracking, training and development tracking and customer complaints management among others - all in a paperless and visible manner.

Another achievement, aimed at increasing transparency in the manufacturing process, was the installation of real-time webcams in processing rooms and the control center, to enable customers to monitor the handling of their products live, 24 hours a day from wherever they are located via password protected access.

Existing Facility Provides a Strong Foundation

Equally impressive was the minimal environmental stress Project Phoenix imposed on the environment. One major reason for this was that Cook, after a global search for a location, decided to refurbish the long-abandoned, formerly RCA/Thomson television assembly plant, which consisted of two buildings with 450,000 square feet each, to house the facility. Cook’s decision to reinvigorate an unused existing structure had the added advantage of eliminating the thorny concerns associated with new construction.

Phase one of Project Phoenix led to the creation of 124,000 square feet of productive space for offices, one manufacturing train - which offers scale-up capabilities to 2,500 L - and a shell for a second manufacturing train, development and quality control laboratories, and warehouse and process utilities to support the two manufacturing trains, using one of the buildings.

Locating a cutting edge biotech facility in the area provided an obvious upside for community and the region. Thomson Consumer Electronics had relocated its assembly operations to Mexico in 1998, and the site it had occupied for 50 years in Bloomington was earning the reputation of a discarded blight - until Cook acquired it in 2004.

But the compelling business potential was clearly valued by the Cook team. The existing bi-level design of the buildings was well suited for the installation of Cook’s bioreactors, which were suspended through the floor. The availability of the second building would dramatically simplify future expansion initiatives to meet the anticipated growing needs of customers.

Another key accomplishment is the facility’s information technology (IT) command center or the “fishbowl” that serves as the control point for all the software systems and automation in the facility. Biometric scanners are used to ensure that only authorized staff has access to this area in an effort to ensure the security of all data.

None of this, of course, was lost on the distinguished panel of judges at the 2007 (the third annual) Facility of the Year Awards competition sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine. This year, the judges selected Cook Pharmica as the winner of the Facility of the Year Award in the Facility Integration category.

Smith & Nephew's Distribution Center to Break Ground

Smith & Nephew Inc. broke ground on its new 210,000-square-foot Memphis distribution center. The new warehouse facility, which is being built at Belz Enterprises' MELTECH Park, will be Smith & Nephew's largest worldwide distribution facility.

Belz Architecture and Construction is building the distribution center, which will be the first area building of its kind to meet 2006 International Building Code seismic requirements, Belz said in a statement.

The climate controlled building will feature a 1,200-square-foot clean room for sterile surgical product storage.

MELTECH, also known as Memphis Logistics and Technology Center, is a Belz Enterprises industrial park located at Holmes and Tchulahoma in Southeast Shelby County.

Based in London, Smith & Nephew (NYSE: SNN) manufactures medical devices. Its Orthopaedic Reconstruction and Orthopaedic Trauma and Clinical Therapies units are based in Memphis.

Johns Hopkins Hospital's New Clinical Building

Clark/Banks, A Joint Venture (CBJV), which is composed of Clark Construction Group, LLC, of Bethesda, Maryland, and Banks Contracting Company, Inc., of Baltimore, is in Phase 1 of a $573-million project to construct Johns Hopkins Hospital's (JHH) new clinical building in Baltimore. The design team is led by Perkins+Will of Los Angeles. Bard, Rao + Athanas Consulting Engineers, LLC, of Boston is the mechanical and electrical consultant, and Thornton Tomasetti of Washington, D.C., is the structural consultant.

The Medical Campus Master Plan calls for the construction of a New Clinical Building and a new entry court for the Hospital along the north frontage of Orleans Street, between Broadway and Wolfe streets. The New Clinical Building will interconnect with the recently constructed Weinberg Building to form a new state of the art health-care facility, replacing greatly outdated facilities aggregated at the northern end of the campus. The New Clinical Building will house two distinct building programs in a single structure:

The 530,000 GSF CMH will include 205 inpatient beds (80 med/surg, 20 Oncology, 20 Psychiatry, 45 NICU, and 40 PICU). Also included in the CMH program are: a pediatric emergency room, which is the State of Maryland’s only Phase III pediatric trauma center; a full complement of radiology equipment; 10 operating rooms for children; outpatient services for oncology, psychiatry, and the Pediatric Clinical Research Unit; outpatient services for medical and surgical specialty clinics; 3 OB operating rooms; 8 LDR’s; 35 ante/post-partum beds; and associated support space.

The 860,000 GSF CCT will include 320 beds (seven 32-bed acute care units and four 24-bed critical care units), 20 operating rooms, 24 interventional labs, 16 endoscopy/bronchoscopy rooms, a full complement of radiology equipment including MRIs and PET/CTs, an adult emergency department, and associated support space.

The 1.5-million-square-foot medical building will feature two connected towers.

Construction Begins on New Orleans' Cancer Center

After years of talking, planning and dreaming, the first steps have been taken toward building a cancer center that is designed to be nothing less than a scientific and economic mainstay of New Orleans' post-Katrina economy.

The health sciences centers of Louisiana State and Tulane universities, as well as Xavier University, are partners in the project, which is envisioned as a center for treatment, teaching and research as well as an economic engine for the city's renaissance.

The 10-story building will have about 175,000 square feet of work space, Moye said, and about 300 people are expected to be employed there when the center opens in 2010.

The first test piles were driven two weeks ago, he said, and groundbreaking is expected to occur Oct. 1.

The Legislature this year approved enough money to cover the construction cost, which is expected to be about $94 million.

Preliminary planning was under way three years ago, but Hurricane Katrina put everything on hold, said Steve McDaniel, the principal in charge of the project for RMJM Hillier of Philadelphia, the building's architect.

That firm's local partner is Lyons & Hudson.

The center will rise on a tract bounded by Tulane and South Claiborne avenues and Gravier and South Derbigny streets. The LSU Board of Supervisors will be asked to approve leasing the land, but that is expected to be a formality, Hollier said.

That part of New Orleans flooded after the levees broke. Given that experience, the plans were retooled to raise all of the building's electrical equipment off the ground to protect it from high water, McDaniel said.

Although their medical centers are side by side, Tulane and LSU had separately explored the idea of developing a comprehensive cancer center for nearly a decade.

In 2002, the universities decided to work together. The result was the Louisiana Cancer Research Consortium, which is building the center.

Xavier, is celebrated for its College of Pharmacy and its success in preparing scientists for medical careers, became a partner in the project in May.

The center's immediate goals are to stimulate the economy and provide a top-flight research, training and treatment center that will compete with renowned facilities in Birmingham, Ala., and Houston for patients and cancer specialists.

Its eventual goal is designation by the National Cancer Institute as a comprehensive cancer center. This accolade, which has been bestowed on 61 centers, signifies that the institution is among the best in the country for cancer research, treatment and education

Ochsner Beginning Major Renovation of Medical Campus

Ten months after it bought the heavily damaged hospital from a competitor, Ochsner Health System has begun a major renovation to transform the former Memorial Medical Center on Napoleon Avenue into a combination of medical offices, a traditional hospital, an imaging center and a housing complex for the elderly.

The campus, anchored by a bustling 317-bed hospital before Hurricane Katrina, closed after the storm and became embroiled in controversy last year, when the state attorney general accused a doctor and two nurses of murdering fragile patients there during the disaster.

After Ochsner bought the hospital from Tenet Healthcare Corp. last October, it changed the name to Ochsner Baptist Medical Center and began planning how it would fit into an empire that includes three hospitals in Jefferson Parish, one in Raceland and one in Baton Rouge.

Ochsner has operated a small surgical hospital and two medical office buildings on the Baptist campus since last fall, and its executives said this week that they plan to have three operating rooms and 25 inpatient beds open by the end of October. They will also launch an imaging center in November and begin offering radiation therapy for cancer patients by January.

From there, Ochsner will begin a more dramatic transformation of the Uptown campus. The main hospital building is now closed, but by the first quarter of next year, Ochsner expects to reopen the third and fourth floors of the Clara Street wing. Those floors can accommodate up to 86 beds, bringing the total to 100 by early next year.

Although Tenet operated more than 300 beds at the hospital, Ochsner plans to cap bed capacity at about 100 -- about a third of the size of its nearest competitor, Touro Infirmary. The company will convert the remainder of the main hospital building into a 200- to 250-unit development for seniors that will include independent apartments, assisted living and nursing home care.

The senior housing will occupy floors three through eight of the main hospital building, and the second floor may hold a laboratory, a pharmacy and a blood bank.

Ochsner will consider restoring the emergency room on the first floor as additional hospital beds open in the Clara Street wing.

FDA Approves ImClone’s Manufacturing Facility

ImClone Systems, Inc. received approval from the FDA for a second facility to manufacture Erbitux. This new 250,000-sq.-ft. multi-suite manufacturing facility, referred to as "BB50", more than doubles the company's total production capacity for Erbitux.

"The FDA approval of BB50 represents the culmination of ImClone's efforts over the last several years to establish this state-of-the-art facility. This now provides us with a great deal of strategic and operational flexibility in pursuing additional commercial opportunities going forward," said Richard P. Crowley, senior vice president, biopharmaceutical operations of ImClone Systems. "Together, our two manufacturing facilities provide us with the capacity to produce Erbitux and future products for worldwide development and commercialization, and serve to support our initiatives for the long-term growth and success of ImClone."

Construction of BB50 was completed in 4Q2005. This facility is designed to contain three distinct suites with a total future production capacity of as much as 110,000 liters. The initial validation of one of the suites was completed during 2Q2006 at which point the company began producing Erbitux. The other two suites at this facility will enable the company to produce Erbitux, ImClone products, or third-party products under contract manufacturing agreements, down the road. Both BB50 and BB36 are located on ImClone's Branchburg, N.J. campus.

Pfizer Breaks Ground at Chesterfield

Pfizer broke ground on a $50 million expansion at its Chesterfield campus that reflects the company's increased investment in biopharmaceuticals. The expansion doubles the size of a pilot plant that produces protein-based, injectable biologic drugs for clinical trials.

The expansion includes the addition of fermenters, bioreactors and other equipment used to grow, purify and isolate proteins. The site will enable the company to increase quantities of a single biologic needed for later-stage clinical trials, and to work on more projects simultaneously. The facility is expected to be operational by mid-2010.

Amgen Cuts Not to Affect Irish Jobs or Factory — County Cork Plant Will Be Built

A spokesperson for the company, which is building an €820m plant in Carrigtwohill in Co Cork, said the job cuts announcement concerned the US and would not have any effect on its Irish operations.

The company says it remains fully committed to its plans to build a plant in Cork, which it hopes to complete by 2012, two years later than previously scheduled.

The biotechnology company plans to invest $1bn (€0.82bn) in a process development, bulk manufacturing and fill and finish facility which will employ more than 1,100 people in Cork by 2012.

In April 2007, Amgen had announced a delay in the schedule for construction of the plant after a review.

The projects were initially meant to be built during 2006 and completed by 2009. More than 70% of the Amgen jobs will be for third-level graduates, such as pharmacists and microbiologists as well as chemical and process engineers.

Amgen is the world leader in using DNA and molecular biology technology to make drugs to tackle cancer, chronic kidney disease and other conditions.

The company employed over 14,000 people worldwide prior to the latest job cuts.

The company said that it had considered other countries for the plant and chose Ireland due to its "thriving biotechnology community, infrastructure to support biologics manufacturing, emphasis on education and attractive business climate"', as well as the support of IDA Ireland and the Government.

Pacific Land Limited Is Waiting to Build a $1 Billion Biotechnology Park in Hanoi

Ireland’s Pacific Land Limited is waiting for a license to build a $1 billion biotechnology park in Hanoi’s outlying Tu Liem district. HaBiotech will see research into new drugs and products for agriculture and environmental protection.

It will be a bio-industrial complex comprising a biology nursery section and hi-tech labs with advanced facilities to facilitate research, development, and training. The park is expected to be up and running in three years.

Vietnam Sitting on FDI Proposals Worth $40-billion

License applications for foreign direct investment projects worth US$40 billion are lying on its desk, the Vietnamese Ministry of Planning and Investment said, adding many of them are eminently viable.

Around 40 percent of it was in the property and tourism sectors, the ministry’s Foreign Investment Department said.

Swiss firm Trustee Suisse wanted to tie up with local state-run construction group Vinaconex to build a $2.7 billion urban-tourism-finance complex in Phu Quoc island, 280 kilometers west of Ho Chi Minh City

The South Korean conglomerate that was building the Kumho Asiana Plaza in the heart of HCMC wanted to invest $2.5 billion in developing the Giang Vo Culture and Trade Center and My Dinh Exhibition Center in Hanoi. The two are expected to be built before 2010.

The technology sector is likely to witness massive investments from Taiwan and the UK.

Taiwan’s Foxconn, the world’s largest electronic outsourcer, is poised to invest $5 billion in seven destinations around the country – HCMC, Hanoi, Da Nang, Lang Son, Vinh Phuc, Bac Ninh, and Bac Giang.

It has recently obtained the nod in principle to invest $1 billion in HCMC.

It has already signed a contract to invest another $1 billion in the northern provinces of Bac Ninh and Bac Giang this year.

Ireland’s Pacific Land Limited is waiting for a license to build a $1 billion biotechnology park in Hanoi’s outlying Tu Liem district.

HaBiotech will see research into new drugs and products for agriculture and environmental protection. It will be a bio-industrial complex comprising a biology nursery section and hi-tech labs with advanced facilities to facilitate research, development, and training.

The park is expected to be up and running in three years.

Xcelience Expanding Operations

Xcelience, a leading source for formulation development and clinical trial manufacturing, has expanded its ability to provide drug development solutions through the acquisition of an additional 24,000 sq ft building.

The recently acquired property, located less than 0.6 miles away from the current location, will accommodate Xcelience’s growth by doubling its capacity. They will continue to operate out of both facilities so as not to interrupt operations.

Rentschler Biotechnologie Commissions New 500 liter GMP Manufacturing Suites

With the commissioning of two new GMP manufacturing suites, Rentschler Biotechnologie looks forward to completing the first phase expansion of its operations. Both systems will be used to produce therapeutic proteins and monoclonal antibodies

The new fermenter lines with 500 L working volume each are sized such that, depending on the respective requirements, different cell culture processes can be run (batch, fed-batch, or perfusion). The ensuing protein purification is performed with state-of-the-art processes in two suites upstream and two suites downstream of the obligatory virus inactivation.

The first of two new 2,500 L multi-process fermentation suites is slated for commissioning in mid-2008. Both can optionally be used to run perfusion processes. The expansion project as a whole comprises a new laboratory building, a central energy station, a logistics space as well as additional facilities for sterile filling of syringes and injection vials.

The global market for therapeutic proteins and monoclonal antibodies is growing continually. Demand for corresponding manufacturing capacity is rising in parallel. Besides allowing Rentschler to offer its customers development and manufacture of biopharmaceutical drugs for the phases of clinical trials, the company's expansion project launched in 2006 will also pave the way to future market supply of large output volumes of active pharmaceutical ingredients.

As a full-service contract manufacturing organization (CMO), Rentschler Biotechnologie now offers a total of eight stand-alone GMP suites (10 suites from mid-2008 on) to the market for process development on the smallest scale up to cGMP production in the 2,500 L range. Besides process development and production including formulation and fill & finish, add-on services such as assistance in drug registration and formulation development are being offered.

Abraxis Acquires Watson Injectables Facility

Abraxis BioScience, Inc. has acquired a sterile injectable manufacturing facility in Phoenix, AZ, from Watson Pharmaceuticals, Inc. This facility currently manufactures products for both Watson and third parties and is capable of manufacturing lyophilized powders, suspension products, and aqueous and oil solutions. Under the terms of the agreement, Abraxis will serve as a contract manufacturer for certain injectable products currently manufactured in this facility for a specified period of time. Financial terms were not disclosed.

This fully equipped facility is approximately 200,000 sq. ft. and includes manufacturing and chemistry and microbiology labs. Abraxis expects that this facility, along with its manufacturing facility located in Melrose Park, IL, will manufacture the company's current and future products such as Abraxane for Injectable Suspension after completion of the planned separation of its proprietary product business -- Abraxis Oncology and Abraxis Research (the new Abraxis BioScience) from its hospital-based product business —Abraxis Pharmaceutical Products (APP).

Lubrizol Opens Facility

U.S.-based Lubrizol Corporation, the world's leading specialty chemical company opened its new world-class facility in Senawang to serve its growing global market.

The injection moulding compounds plant under Lubrizol Advanced Materials Malaysia Sdn Bhd, formerly known as Noveon Malaysia Sdn Bhd, will make products for the estane engineered polymers line.

Lubrizol's vice president and general manager of estane engineered polymers, Mike Vaughn, said the new plant represented a further RM20 million injection to company's investment of over RM50 million since its inception here in 1999.

The new plant would serve the electronics industry by manufacturing injection moulding resins to support Lubrizol's market-leading electro-static discharge (ESD) solutions and services.

Lubrizol produces and supplies technologies to improve the quality and performance of its customers' products in the global transportation, industrial and consumer markets.

The technologies include lubricant additives for engine oils, other transportation-related fluids and industrial lubricants, as well as fuel additives for gasoline and diesel fuel.

In addition, Lubrizol makes ingredients and additives for personal care products and pharmaceuticals, and specialty materials, including plastics technology and performance coatings in the form of specialty resins and additives.
Lubrizol owns and operates manufacturing facilities in 20 countries, as well as sales and technical offices around the world.

Founded in 1928, Lubrizol has about 6,800 employees worldwide and its turnover for 2006 was over US$4 billion with Asia Pacific and the Middle East contributing over 13 percent of the total revenue.

Its major clients in Malaysia include Samsung, Seagate, Dell, Sony and other leading companiees in the hard disk drive industry and display technology sector.

Egenix Expands Labs for Biotechnology

Egenix Inc., a small biotechnology company based in Dutchess County, contracts with labs from Boston to Beijing to work on new cancer diagnoses and treatments.

And now it has lab space locally as part of the University of Rochester's new Rochester BioEnterprise Center — an incubator for small or emerging biotech companies.

The BioEnterprise Center, is the latest piece of infrastructure meant to help the area's growing biotechnology and biomedical industry by providing a place where young firms have access to lab and office space, as well as big-ticket equipment such as autoclaves — a pressurized oven usually used in labs for sterilization.

The Rochester area has no shortage of places for new tech firms to get their start. Aside from the BioEnterprise Center, off Jefferson Road in Henrietta, there is the Lennox Tech Enterprise Center and Rochester Institute of Technology's High Technology Incubator, both also in Henrietta, and the Infotonics Technology Center in Canandaigua.

The economic development organization Greater Rochester Enterprise has named biotechnology as one of the area's four business strengths that could see potential growth.

The Infotonics Center houses six small microsystems firms and plans to start work this fall on subdividing 20,000 square feet of space to accommodate more.

The area's startup tech firms can likely also find the employees they need locally, due to the engineering, technology and life sciences programs at area colleges, particularly at UR and RIT.

High Tech Rochester — which is operating the BioEnterprise Center and the Lennox Tech Enterprise Center — offers tenants business training and resources.

Egenix established a Rochester presence about five years ago when it hired away two Ortho Clinical Diagnostics staffers and bought some of that company's equipment.

Indian Players like the Taste of Euros and Dollars / Interview with Clestra Chief

Jean-Luc Bukard, Chairman, Clestra Cleanroom shares his views on the market for cleanroom technology in India and company strategies, with Arshiya Khan.

Q. What is the main focus of your business?

A. Our main business remains manufacturing and installation of the movable partitions and ceiling systems for office and industrial applications. We started the movable works company in the beginning of this century in the United States and expanded in Europe in 1961 and then to Asia.

Q. What are the most important things that have to be considered while designing cleanroom solutions for pharma companies?

A. Flexibility is the most important thing to be considered while designing products for pharmaceutical companies. There are other companies who are into the same business but their approach is just of being a vendor. We like to call ourselves partners in the project rather than just vendors who respond to the client's drawings.

Q. What are the challenges faced by Clestra while designing cleanroom solutions?

A. Our major challenge is to explain to people that we are not just a construction company and that we should not be categorised with those who design a brick wall. We are a solution provider who develops modular walls and ceilings. No matter how much you explain this to them it takes time for them to understand. So convincing clients is a major challenge.

Q. What is the importance of after sales service for a business segment like yours?

A. Being customer centric, we design products that are flexible and match our customers needs. Our products are designed keeping in mind the customers needs and trends followed in the market. They are movable works that can also be relocated. We offer our experience to the Indian market. So, one third of our revenue is service based.

Q. What business strategies has the company deployed to attract clients?

A. We position ourselves as a construction company, which is very close to its customers. Right from designing, construction, management and installation we develop products for our customers, considering their needs. Moreover, we also cater to their queries from start to finish. Our basic positioning is being at the front end of the customer and mustering the full production cycle from the design of the product onwards.

Q. How has this industry advanced over the last few years?

A. There are 20,000 domestic pharmaceutical facilities serving a population of one billion, who now plan to go global. So these companies have to match their GMPs and processes with the Europeans, Australians, Americans and so on. So we have grown with our thought process in understanding, applying and making our processes here.

Q. What is your take on the Indian market for cleanrooms? Who are your clients?

A. The Indian market is the most happening and fastest growing market. Indian players are eyeing foreign markets, as they too want to taste Euros and Dollars. Clestra's help and experience would be crucial for the Indian players to meet international GMPs. As we have done all kinds of projects in most of these countries, we are able to avoid previous mistakes because of our experience. So to be more specific, we are not confined to just a modular wall or a modular ceiling. We know industrial operations and the needs of the pharmaceutical industry. So we can suggest and bring in those solutions and it's our strength. Our clients would include Intas Pharmaceuticals, Ranbaxy Laboratories, Claris Lifesciences, Serum Institute of India, Dr Reddy's Laboratories, Biocon, Sun Pharma, Wockhardt, Astral, etc.

Q. How has the company grown over the years and what growth do you expect in the future?

A. Our company has shown consistent growth over the last two years. Our revenues have grown from 155 million Euro in the last three years to 195 million Euro. We should be over 200 million Euro this year. We sell good products to experienced customers and we need to have flawless execution. We are able to discover the specificity of the customer and the market and the customer's need in the market, in contrast to initial difficulties of bringing things together and adjusting to the contract difference.

The growth factor is going to be dependent on the market that we are in. In France, we have a leading position but our growth is not going to be at a furious pace. Though a newcomer in India, we expect to double every year for the first few years. And that depends upon the maturity of the market, and what market segment we will pursue.

Q. After France and Korea, what was the rationale behind setting up a facility in India?

A. India is going to be a key factor in our future growth. Europe is a mature market and when we achieve a two percent growth rate we create a record there, but even if we get a ten percent growth in India we are lagging. India is a growing market and we are trying to expand here by growing in the pharmaceutical industry. Hence we have introduced this concept. In order to be consistent with our strategy, we need a local manufacturing unit, so that nothing holds us back. We master everything from the design to the final installation of the product. That is what we want to do with this facility in India. I hope we will be more surprised by the growth potential at the end.

Q. What is the USP of this facility?

A. The USP would be our international experience, which most of our competitors don't have. For us it is just not the facility, but a part of the solution that we want to provide. Anyone can produce, but we want to master our quality and deliver the final solutions to our customers. In fact, it is not unique; what is unique is that these products were designed, implemented and managed by us. So also we are there to see how it is applied and guide our customers. There are around 10-12 competitors and most of them sell against us, which is a compliment to us. Some of them are like vendors rather than solution providers.

Q. What is the market size of the cleanroom technology segment?

A. I do not know the exact market size, but lets work backwards. If ten percent of the 20,000 pharmaceutical companies expand on an annual basis, that would be about 2,000 companies. If you consider that each project is worth approximately Rs 50 crore, out of which ten percent (Rs 5 crore) goes into the manufacture of cleanrooms, this would work out to around Rs 10,000 crore worth of clean oom construction happening at a given time. This is a generic calculation because some of them don't want to talk about it. But even if we consider 50 percent of them constructing cleanrooms, the figure would be Rs 5000 crore.

Q. What are the growth drivers and the potential of this technology?

A. The acceptance of our Indian manufactured pharmaceutical products outside India is the growth driver for us. And the potential is huge, as we are not only into pharmaceuticals but also biotech and other business segments.

This cleanroom technology is being used in various forms in various ways. Sometime back it was more in electronics and now it is more in pharmaceuticals. As it progresses it will be in medical devices, biotech and then it will definitely hit the foods segment. Considering the ever-expanding number of applications and requirements, the market is all set to grow at a high speed.

Q. From the criticality aspect, how critical are cleanroom solutions for the pharmaceutical industry?

A. Manufacturing cleanrooms for pharma companies is an art, especially the finishing and the secondary process. If the cleanroom doesn't work, pharma companies cannot produce and if they cannot produce, then they will be upset with the cleanroom designers. So we have to find a solution as per their liking. And if we don't listen to the customers, we are not going to be in the market. So it is the heart of the facility, along with the process equipment of course.

Q. What similarities or dissimilarities have you observed between Indian, European and Korean pharma markets?

A. There is uniformity in this market, as the requirements are the same. If companies have to meet GMPs, they have to think in a similar way. Cleanroom is a worldwide market too and they need to design a cleanroom that suits FDA and GMP requirements. But the way in which they are implemented is different.

Larger companies tend to stay ahead by adhering to GMPs and quality standards and it becomes a challenge for other pharmaceutical companies in different countries to follow them. So the idea of us putting a facility in India was to catch up with the other countries adhering to GMPs and bring the products at a cheaper price. Our aim is to bring a solution that has been established in Europe and US into India. For that, we are trying to find and use Indian materials so that we can have the same product and solution at Indian prices.

Q. Going forward, what role will India play in your operations?

A. We hope that it becomes the focus of our company since the Indian market is very happening and growing at a fast rate. As we have a worldwide presence, the growth factor is clearly going to depend on the fastest growing country, and India falls into that category.

McIlvaine Company,

Northfield, IL 60093-2743

Tel: 847-784-0012; Fax: 847-784-0061;

E-mail: editor@mcilvainecompany.com;

Web site: www.mcilvainecompany.com