SAFC invests in high-potency capacity
Covance expands drug-development services
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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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