Gains in secondary manufacturing
CMOs involved in dosage-form manufacturing are also expanding capabilities for highly potent substances. Earlier this year,
Almac Sciences (Craivagon, Northern Ireland) formed a pact for fill-and-finish services with the Center for Pharmaceutical Science and Technology
(CPST) at the University of Kentucky. In February of 2007, the university spun off the CPST into a private company, Coldstream
Laboratories. Coldstream will provide intravenous formulation and sterile fill of cytotoxics and potents for clinical-trial
applications. CPST opened a new $17-million sterile manufacturing facility in May 2006. By 2011, the Coldstream facility is
projected to have annual revenues of $15 million and employ up to 50 science-based and other professional staff. The collaboration
positions Almac Sciences in upstream offerings in cytotoxics. Almac also offers contract manufacturing of high-potency APIs
at its facility in Craigavon, Northern Ireland.
Baxter BioPharma Solutions
(Round Lake, IL) recently completed the lyophilization capacity expansion at its cytotoxic contract-manufacturing facility
in Halle, Germany. The expansion added two large-scale lyophilization units to increase the site's total cytotoxic lyophilization
capacity to four dedicated lyophilizers.
Encap Drug Delivery
(Livingston, Scotland) is building a £3-million ($6.1-million) pharmaceutical development and manufacturing facility in Livingston,
Scotland. The facility will include dedicated, high-containment suites for formulation development and the clinical and commercial
manufacture of high-potency and cytotoxic compounds. The facility is scheduled to be operational by June 2008.
(London) is investing EUR 16 million ($23 million) to more than double its sterile cytostatics (oncology) manufacturing capacity
at Braine l'Alleud, Belgium. The investment adds a second production line to increase lyophilization capacity for the US,
European, and Japanese markets. The investment program will be undertaken in stages between mid-2007 and 2010.
(San Diego) is adding cytotoxic and high-potency drug-development capabilities to its pharmaceutical chemistry development
services. Services for cytotoxic and high-potency compounds include analyticalmethod development, preformulation testing,
formulation development, manufacturing for early-phase clinical trials, release testing, and stability testing and storage.
Pharmatek's cytotoxic and high-potency development services will be carried out in a separate dedicated facility. Its manufacturing
capability includes two validated and licensed Class 100,000 high-containment suites designed with barrier technology for
the CGMP manufacture of final-form drug products.
Patricia Van Arnum is a senior editor at Pharmaceutical Technology, 485 Route One South, Bldg F, First Floor, Iselin, NJ, 08830, tel. 732.346.3072,