PHARMACEUTICAL
UPDATE
McIlvaine Company
April 2006
Clariant Expands at Springfield, MO
For its part, Clariant continues to make modest investments across its production network to support existing and future projects. Having recently completed a $5 million upgrade to its Springfield, Mo., unit, the company announced that it will put another $8 million into the site to prepare for the production of an antiviral intermediate. The expansion is scheduled for March 06 updatecompletion in June 2006, and production of the intermediate should begin by the second half of the year.
FIS Adds cGMP Production Unit and Labs in Italy
Italian custom synthesis company FISunveiled both small- and large-scale manufacturing expansions, which add to the $120 million the company has invested over the past 10 years in its Montecchio, Italy, facility.
In 2005, FIS opened three current Good Manufacturing Practices (cGMP) kilo labs at the site to widen the range of services available to its customers. Kilo labs installed last April for active pharmaceutical ingredients (APIs) and steroids are currently in use, while a cytotoxics kilo lab is scheduled to be operational by the end of the third quarter 2006.
The cytotoxics lab complements an existing commercial-scale production suite at Montecchio, installed in 2003 for a specific customer project. The addition of smaller scale production capabilities will help feed more cytotoxics into the company's pipeline, said Stephen N. DiSalvo, U.S. area manager for FIS's custom manufacturing division.
In a similar linkup, a commercial-scale steroid production unit is also being added at Montecchio to support a project coming out of the new kilo lab.
The company is also installing a cGMP production unit at its Termoli, Italy, facility, which previously had been dedicated to non-cGMP manufacture of intermediates. The new unit is expected to be completed by the end of the year.
Ferro Pfanstiehl Laboratories Has New Class IV Lab in Waukegan, IL
Ferro Pfanstiehl Laboratories has commissioned a new Class IV containment kilo lab in Waukegan, Ill., for low-volume production of high-potency APIs. John A. Minatelli, senior director for commercial development, said Pfanstiehl's existing facility primarily serves pharmaceutical companies with drugs in Phase II or III of clinical development. The $4.3 million addition, he said, offers production quantities up to 5 kg for customers with preclinical or Phase I compounds.
Alphora Research to Expand Peptide Manufacturing
Alphora Research plans later this year to invest roughly $10 million to expand a large-scale cGMP peptides manufacturing plant in Vista, Calif. New equipment will enable peptide production up to the 50-kg scale.
Although best known for its catalog peptides business, American Peptide is gaining recognition for custom peptides manufacturing. Currently, American Peptide is producing two commercialized peptide drugs. The drug master file has been completed for a third product, with a New Drug Application expected to be filed later this year. As such, "we expect to reach maximum capacity in 2007 and will need to build new capacity in late 2006/early 2007 to meet business demand," said Chris Bai, the firm's president and chief executive officer.
Helsinn to Add Capacity in Ireland and Switzerland
Helsinn recently increased capacity at two European facilities, adding 8,000 L of reactor capacity in Biasca, Switzerland, and a 6,000-L reactor with receiving vessels and drying capacity in Dublin, Ireland, according to Gabriel Haering, commercial director. Helsinn is expanding its production to meet current customer needs and accommodate projects advancing from lab-scale production.
Degussa Wants Asian Manufacturing Site but Contracts with Hikal in India
Degussa's exclusive synthesis unit unveiled the next step in its India strategy, a long-term nonexclusive production agreement with Mumbai-based contract manufacturer Hikal. The pact allows a customer to tap into the cost competitiveness of an Asian supplier while also capturing the technology expertise Degussa can offer, said Rudolf Hanko, vice president of the exclusive synthesis business.
One product is already being manufactured in India under the agreement, with "more to follow," Hanko said.
Degussa's first step into India came in late 2004, when the company opened R&D facilities in Mumbai. The latest move is part of a greater push into the region. "As a next step, we want to be the majority owner of a manufacturing site in Asia," Hanko said.
International Specialty Products Will Soon Outgrow Facility in India
International Specialty Products is expanding in India. The company put down roots in the country in late 2005 with the opening of the ISP India Technical Center in Hyderabad, intended to provide R&D support for ISP Pharma Technologies and customer support for its excipients business.
On the basis of strong initial customer interest, ISP expects to quickly outgrow the Hyderabad facility, which currently employs 10 researchers. "We're now exploring larger sites with room to expand," said Albert W. Brzeczko, vice president of global pharma R&D at ISP. His goal in the next three to five years is to increase headcount at the site to 50. The company may even consider expanding its activities in India into commercial manufacturing, which could include formulation or finished-product operations.
CiVentiChem invests in a cGMP Pilot Plant in Hyderabad
CiVentiChem, which has since 2002 performed contract research and custom synthesis in India through its subsidiary Indus BioSciences, is expanding its manufacturing capabilities in the region. CiVentiChem is making an initial $2 million investment in a cGMP pilot plant in Hyderabad, India, that should be operating by the end of the year, according to President Bhaskar R. Venepalli. Venepalli said customers, including Eli Lilly & Co., Cephalon, Novartis, and Amgen, are now more willing to work with contract manufacturers with operations in India than they were two years ago because of new laws protecting intellectual property. He says the company will eventually spend about $10 million on the facility.
Nicholas Piramal Wants to be One of the Top Three Custom Manufacturers
Nicholas Piramal has the ambition of becoming a top-three player in the global custom manufacturing market. The company's custom manufacturing business currently brings in about $70 million in sales, a figure that Executive Director Michael J. Fernandes said would need to grow to the $350 million to $400 million range to put it among the top three.
As a first step, the company bought Avecia Pharmaceuticals late last year. Fernandes also sees finished-dose drug formulation becoming an integral part of a full offering to pharma customers. He said Nicholas Piramal, which already has formulation assets in India, is considering adding formulation capacity at the former Avecia API facility in Toronto.
The company believes such organic growth will take it a long way toward its ambition, but it is also looking at adding technology assets, particularly those that can bring down the cost of large-scale manufacturing, as well as alliances and acquisitions. "We need to look at other opportunities to create and complete this global footprint," Fernandes said.
North China Pharmaceutical Group is Largest Pharmaceutical Producer in China
The North China Pharmaceutical Group is the largest pharmaceutical production enterprise in China, producing over 300 products, including antibiotics, semi-synthetic antibiotics, vitamins, genetically engineered pharmaceuticals, agrochemicals and veterinary.
'The North China Pharmaceutical Group is a completely state-owned corporation that has been transformed from the original North China Pharmaceutical Factory that was set-up in 1958. The company has become increasingly commercialized, and has developed total assets of RMB 11 billion, with a compliment of 18,000 staff.
The Group now comprises 27 affiliated companies, either wholly-owned by the Group, or with a controlling share-holding, key amongst these being the North China Pharmaceutical limited liability stock company, that has listed A shares on the Shanghai Stock Exchange. The Group also has 17 subsidiary companies with foreign investment or foreign co-operation.'
ISB to Create Center for Systems Biology in Seattle
On March 28, The Institute for Systems Biology (ISB) received a five-year, $16.3-million grant from the NIH for the operation of the NIGMS National Center for Systems Biology.
“Scientifically, the focus is on using questions in biology to drive the development of technologies and computation,” says John Aitchison, Ph.D., associate director of the center, “which can in turn enable new experimentation, interpretation, and insight into complex biological systems.” In addition, “the center will play substantial roles in providing mechanisms for cross-disciplinary training and collaboration and educational programs; all toward a future of predictive, preventive, and personalized medicine.”
Many programs and core facilitates of the center will be ready for use immediately, states Dr. Aitchison, where as others will take up to a year, continuing to grow over the period of the grant.
“The center is a highly collaborative program in which researchers from different disciplines are brought together to focus on four central biological themes,” he says, “chosen to represent increasing biological complexity of dynamic responses of biological systems.”These themes are halobacterium, yeast, innate immunity, and systems approaches to human disease, which “leverage one another in terms of complexity and specifics of the dynamic response being examined,” explains Dr. Aitchison.
Halobacterium represents responses to environmental perturbations; yeast shows responses to metabolic environmental perturbations leading organelle biogenesis and filamentation; innate immunity exhibits responses to infectious agents, focus on toll-like receptors, and decoding of the nature of infections by macrophage; and human disease research will depict response to disease and its progression, specifically early detection in prostate cancer.
“On the simplest level of complexity, we believe we have a realistic chance of detailed mathematical molecular-based models of key responses,” asserts Dr. Aitchison. “What we learn from these simpler systems, we apply to the systems of higher complexity.”
The new Center will be housed at ISB’s research and office building in Seattle. It will be the sixth of its kind in the U.S. Besides having different experimental and research foci compared to the other systems biology centers, Dr. Aitchison says the center places a lot of effort on developing new technology and computation, as well as an emphasis on bringing it to K-12 education
HollisterStier To Double Capacity, Lab Space in $30 Million Expansion
HollisterStier Laboratories has announced plans for a $30 million facility expansion. The company will add a second high speed filling line that can handle 2-100mL vials and fill approximately 400 vials per minute, doubling its current laboratory space, while adding an office complex. The clean room complex includes aseptic compounding areas, a new component preparation area, and an aseptic storage area. HollisterStier also projects increasing personnel by approximately 40% during the next three years.
"The new filling line and expanded lab space enhances our ability to meet the unique needs of our customers. With the expansion, we will also increase our various customer support teams," stated Anthony Bonanzino, Ph.D., president & chief executive officer.
HollisterStier is doubling its laboratory space for the Quality Assurance and Quality Control departments. "QA is one of the most vital components to our organization. The new construction allows for critically needed lab bench space and new instrumentation," he said.
The project increases the Spokane, Washington facility to a total of 185,000 sq. ft. Construction on the laboratories and office building begins in the fall of 2006 with completion expected in May of 2007. The construction for the filling line begins in Q42006, with commercial production commencing in Q42008
New Biotech Facilities Planned in Arizona
SkySong is building a 1.2-million sq. ft., $320-million facility that will house private companies and ASU’s Technopolis, Arizona Technology Enterprises and the Edson Student Enterpreneur Initiative. It is expected to open in 2007.
San Diego developer Lee Chestnut unveiled plans for a three-story, 35,000 sq. ft. , multitenant wet-lab facility at Papago Park Center in Tempe, AZ. Chestnut is negotiating for additional wet-lab space of up to 80,000 sq. ft.
Sanofi-Aventis, the world’s third largest pharmaceutical company, has plans to add 100,000 sq. ft. to its Tucson facilities, tripling their current size.
“The global biotechnology industry’s revenues are growing at strong rates, product approvals are bringing innovative drugs to market, and the long-elusive goal of profitability is quickly approaching,” said Donn Szaro, leader, global biotechnology and pharmaceutical sectors, Ernst & Young.
By virtually every performance indicator, the global biotechnology industry showed robust growth in 2005. Significant global milestones include: Revenues of the world’s publicly traded biotech companies grew 18 percent in 2005; as revenues increased, the industry’s net loss decreased by 30 percent; and the U.S., Canada, and the Asia- Pacific region collectively improved their bottom line by about $3 billion.
“Since our first report 20 years ago, we’ve seen historic scientific advances and dramatic changes in market conditions combine to produce a rapidly maturing industry,” said Szaro. “Companies from around the globe are pioneering new technologies, platforms, industry segments, and business models.”
A leader in the next wave of biotechnology -- the application of genomics and other life science technologies to the creation of healthier foods, new energy sources, innovative materials and environmental and industrial biotechnology -- as well as a highly productive developer of novel drugs and health care products, diagnostics and Bio-IT tools, New Zealand showcased the country's rapidly growing biotechnology industry April 9-12 at BIO 2006 in Chicago, IL.
Over 40 New Zealand companies and research institutions attended the international conference as part of a delegation led by Ambassador Roy Ferguson, New Zealand's Ambassador to the United States. Ranked by the World Bank in December 2005 as the best country in which to do business, New Zealand is reaching out at BIO to partner with leading U.S. and international companies and research institutions.
"New Zealand is renowned for its innovation in the life sciences, built upon a history of more than 150 years of research applied to agriculture and human health, as well as a public-private approach to business," said Chris Boalch, director of Biotechnology, New Zealand Trade and Enterprise. "Moreover, the country's global mindset is illustrated by the diverse range of connections between New Zealand scientists, companies and the international biotechnology industry, including strong, growing ties to the U.S. Midwest."
There is a shift in focus from enhancing commodity productivity to creating new value from the agriculture community. New Zealand has a strong capability in pasture-based plant and animal genomics, as well as access to unique germplasm and growing genomic databases that offer the potential to use plant biotechnologies for a range of new applications, as well as to improve the efficiency of primary food production.
WiCell Research Institute to Establish First National Stem Cell Bank
WiCell Research Institute has been selected by the National Institute of Health (NIH) to establish the federal government's first and only National Stem Cell Bank (NSCB). The job of the bank will be to serve the research community by performing comprehensive characterization of human embryonic stem cell lines and distributing these lines to investigators. The NSCB will also provide technical assistance and training in state-of-the-art methods. One of the first orders of business will be to develop standardized test methods to allow cell lines to be completely characterized and compared. There are over 80 researchers studying human embryonic stem cells at WiCell.
McIlvaine Company,
Northfield, IL 60093-2743
Tel: 847-784-0012; Fax: 847-784-0061;
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