Investing in High-Potency Manufacturing - Pharmaceutical Technology

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Investing in High-Potency Manufacturing
Market demand for cytotoxic drugs is leading CMOs to expand their API manufacturing and formulation services.


Pharmaceutical Technology


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.

NextPharma Technologies (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.

Pharmatek Laboratories (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,


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