CMOs Make Select Investments in Primary and Secondary Manufacturing - Pharmaceutical Technology

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CMOs Make Select Investments in Primary and Secondary Manufacturing
Contract manufacturers and pharmaceutical ingredient suppliers proceed with select investments in biologics manufacturing, small-molecule synthesis, and formulation as the industry prepares for CPhI Worldwide in Milan.

Pharmaceutical Technology

SAFC also completed the construction of two new protein API facilities at its St. Louis manufacturing facility: a 25,000-ft2 CGMP purification and manufacturing suite for transgenic plant and other nonanimal derived protein APIs and a 6000-ft2 facility for purification of animal-derived protein APIs. The expanded capacity seeks to meet increased demand for large-scale supply and will meet late-stage clinical trial and commercial manufacturing needs for transgenic and naturally-sourced APIs.

SAFC completed the initial phase of a two-stage expansion at its SAFC Pharmorphix research facility in Cambridge, United Kingdom. SAFC Pharmorphix provides solid-form characterization and research. The company also expanded Pharmorphix's capabilities into the United States with a new laboratory at SAFC's high-potency API facility in Madison, Wisconsin.

Mid-size players invest

Mid-to small-sized CMOs are investing in production and service capabilities.

Albemarle. In 2006, Albemarle (Baton Rouge, LA) acquired the former DSM (Heerlen, The Netherlands) API and intermediates manufacturing facility in South Haven, Michigan. The acquisition provides kilo-, pilot-, and commercial-scale capacity and also provides Albemarle with certain projects for generic APIs.

Ricerca Biosciences. Ricerca Biosciences LLC (Concord, Ohio), a contract drug-development company, is embarking on a growth strategy in which it hopes to double its revenues by 2009. Earlier this year, it completed a financial restructuring that includes new equity and term facilities totaling nearly $50 million. That financing will help Ricerca to implement a multiyear business plan, which includes a $15-million investment to add chemistry and biological laboratories to its site in Concord, Ohio.

Almac Sciences. Earlier this year, Almac Sciences (Craigavon, UK) expanded its analytical services offerings in bioanalysis, characterization, stability testing, structure confirmation, and batch release. at its facility in Elvingston, Scotland.

The company also started a collaboration for fill-and-finish services with the Center for Pharmaceutical Science and Technology (CPST) at the University of Kentucky, which became a private laboratory, Coldstream Laboratories. Coldstream will provide IV 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; it also offers contract manufacturing of high-potency APIs at its facility in Craigavon, Northern Ireland.

Earlier this year, Almac Sciences also teamed with with BioCatalytics (Pasadena, CA) under which Almac Sciences will provide process development and manufacture for a select group of chiral intermediates and APIs based on enzymatic technology developed by BioCatalytics. BioCatalytics was subsequently acquired by Codexis (Redwood City, CA), which specializes in biocatalysis for small-molecule synthesis.

Last November, Almac Pharma Services completed a $10.5-million expansion of its formulation activities with the addition of extended formulation development services for solid-oral dosage forms from preclinical to pilot scale.

Cambridge Major Laboratories. Earlier this year, Cambridge Major Laboratories, Inc. (Germantown, WI), a pharmaceutical chemistry outsourcing company, partnered with Arlington Capital Partners with the aim of building a drug-development organization focused in three primary areas: APIs, formulation, and regulatory consulting services.

AMRI. In keeping pace with moves by CMOs to offshore locations, AMRI (Albany, NY) acquired the assets of Ariane Orgachem Pvt. Ltd. in Aurangabad and Ferico Laboratories Ltd. in Navi Mumbai, India, giving the company two API and intermediates facilities in India. AMRI also acquired additional land for expansion and plans to invest approximately $15 million to expand and upgrade manufacturing capabilities during the next three years.


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