Expansion Activity of CMOs - Pharmaceutical Technology

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Expansion Activity of CMOs
The outlook is fairly optimistic as contract manufacturing organizations (CMOs) gather at CPhI Worldwide in Frankfurt. CMOs are expanding capacity for small-molecules, biologics, and finished-product manufacturing.

Pharmaceutical Technology

SAFC invests in high-potency capacity

Covance expands drug-development services
SAFC (St. Louis, MO) has invested $45 million in high-potency expansions during the past 18 months. In late 2007, it began operations of a new 600-ft2 HPAPI conjugation suite at its St. Louis, manufacturing facility. The suite is designed for producing early-stage clinical supplies and has capabilities to expand production into commercial scale in multikilogram quantities. The company invested $4.5 million to expand CGMP capacity on a pilot-plant and kilo-laboratory scale at its facility in Madison, Wisconsin. This investment follows a $12-million, 38,000-ft2 HPAPI expansion at its Madison facility, which was completed in 2006. SAFC is investing $29 million for a new facility for large-scale production of bacterial and fungal fermentation-derived HPAPIs in its Jerusalem, Israel, facility. The expansion is scheduled for completion in 2009.

SAFC is proceeding with a $12-million expansion of its viral-product manufacturing facility in Carlsbad, California. The expansion is scheduled to be operational in the second half of 2009. The new suites will add 8000 ft2 of manufacturing space and enable 100-L batch production in stirred-tank bioreactors and 1000-L batch manufacturing in disposable bioreactors. These investments follow a $10-million expansion of commercial-scale API manufacturing and storage capacity, respectively, at its Arklow, Ireland, and Buchs, Switzerland, facilities in 2007.

Dr. Reddy's makes key acquisitions

To build its contract-manufacturing activities, Dr. Reddy's Laboratories (Hyderabad, India) completed two key acquisitions in 2008: Dow Chemical's (Midland, MI) Dowpharma small-molecules business associated with its Mirfield and Cambridge, United Kingdom, sites, as well as BASF's (Ludwigshafen, Germany) manufacturing facility in Shreveport, Louisiana, and related contract-manufacturing business for finished pharmaceuticals. The acquisition of the Dowpharma small-molecules business includes customer contracts, associated products, process technology, intellectual property, and trademarks as well as the transfer of the Mirfield and Cambridge facilities. Dr. Reddy's will also have a nonexclusive license to Dow's "Pfenex Expression Technology" for biocatalysis development.

The BASF acquisition includes relevant business, customer contracts, related abbreviated new drug applications and new drug applications, trademarks, as well as the Shreveport facility and related contract manufacturing activities. It also includes a tolling and supply agreement.

DSM reports gains

DSM (Heerlen, The Netherlands), which provides contract development and manufacturing services for small molecules, biologics, and solid-dosage and sterile products, reported gains in its pharmaceuticals business. Sales increased nearly 4% from EUR 425 million ($627 million) in the first half of 2007 to EUR 444 million ($652 million) in the same period in 2008. DSM recently added aseptic fill–finish manufacturing services for injectable cytotoxic products. The aseptic cytotoxic capabilities include flexible commercial scale fill–finish services for liquid and lyophilized products in vial sizes as large as 65 mL. In early 2007, DSM completed an expansion to its sterile parenteral manufacturing facility in Greenville, North Carolina. It added a clinical-trial-material manufacturing suite capable of manufacturing large- and small-molecule liquid and lyophilized products for Phase I–III clinical trials.

Aptuit adds chemical development services

In December 2007, Aptuit (Greenwich, CT) completed the acquisition of the chemical and pharmaceutical development) business of Evotec (Hamburg, Germany). Aptuit gained an API facility in Oxford, England, and a recently expanded parenteral (injectable vials) fill–finish facility in Glasgow, Scotland.

The Evotec acquisition is the latest move by Aptuit to strengthen its contract drug-development portfolio. Acquisitions in 2007 include SSCI, a solid-form research firm, and EaglePicher Pharmaceutical Services, which provides small-molecule synthesis capabilities, including HPAPIs.


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