A roundup of manufacturing and service expansions.
New York (Aug. 20)—
received approval from the
US Food and Drug Administration
for its second facility to manufacture "Erbitux" (cetuximab). The approval to manufacture Erbitux in the new 250,000-ft.2 multisuite manufacturing facility, referred to as BB50, more than doubles ImClone's total available production-volume capacity.
San Diego, CA (Aug. 16)—
Pharmatek Laboratories added cytotoxic and high-potent drug development capabilities to its pharmaceutical chemistry development services. Cytotoxic
and high-potent services include analytical method development, preformulation testing, formulation development, manufacturing
for early-phase clinical trials, release testing, and stability testing and storage.
Cramlington, UK (Aug. 23)–
opened its new pilot plant at Cramlington to manufacture and supply small-scale quantities of clinical compounds (10–100 kg).
Toronto, ON, Canada (Aug. 13)—
established a team of experts to help manufacturers boost their production of influenza vaccine. The "Special Workgroup for
Applied Technology Transfer" or "SWATT" group, working with the company's "VirusMax" technology, spends several weeks at each
facility to help implement the technology and train personnel.
The VirusMax technology is designed to increase the virus yield from eggs by effectively recovering the virus. "Our technology
can be installed very quickly, and with limited capital costs into existing manufacturing processes," said William J. Gastle,
CEO of Microbix, in a prepared statement. According to the company, the technology has been shown to double vaccine production.
Mississauga, Ontario, Canada (Aug. 1)—
recently expanded to include a 14,000-ft2 facility to support a new pilot-plant facility. The pilot-plant is currently under construction and is targeted for completion
by the end of 2007. This facility includes 200-L and 400-L glass-lined reactors, which includes equipment for cryogenic reactions.
Support functions are also being installed, including warehousing and quality control capabilities.
Kankakee, IL (Aug. 1)—
will invest $15 million to expand its manufacturing facility by adding a high-speed, single-dose syringe-filling line. Plans
call for the line to be operational in 2010, when the company intends to contract with its sister company, CSL Biotherapies,
to provide filling and packaging services for seasonal influenza vaccine.