Expanding high-potency capacity
SAFC (St. Louis, MO) has invested more than $75 million in developing its high-potency manufacturing capabilities in recent
years. These investments include a $4.5-million project to add a CGMP pilot-plant and kilo-laboratory capacity at Madison,
Wisconsin, completed in early 2008; a $29-million investment to expand bacterial and fungal fermentation-derived high-potency
capacity at its facility in Jerusalem, scheduled for completion in 2009; a $30-million investment to build a commercial-scale
high-potency API facility at Madison; and a high-potency bioconjugation suite in St. Louis that was validated in early 2008.
In January 2009, SAFC began operations at a 7000-ft2 laboratory complex in Carlsbad, California, next to its viral production substance facility, which the company gained by
acquiring Molecular Medicine Bioservices. Commissioning of the new laboratories follows SAFC's 2008 announcement of a $12-million
expansion at the site to construct two fully segregated manufacturing suites, which are scheduled to be operational by the
end of 2009.
In September 2008, SAFC began operations at a new reactor at its site in Arklow, Ireland, which increased its large-scale
API capacity by 15% and the site's total capacity to 96,000 L. The investment complements two additional expansions: the building
of a $2.25-million, 15-kg pilot-scale filter dryer designed to double the facility's capacity for small-scale API manufacturing,
which is scheduled to be commissioned in the third-quarter of 2009; and a $1.8-million expansion of the site's CGMP warehouse
capacity.
SAFC is proceeding with its first greenfield manufacturing project in China, a $25-million investment in Wuxi for a large-scale,
non-CGMP multipurpose plant to produce raw materials, intermediates, and final products to support SAFC Pharma, SAFC Supply
Solutions, and SAFC Hitech. The Wuxi site will include a manufacturing plant and analytical, packaging, and warehousing facilities.
The first construction phase is expected to be completed by 2010. Future development phases at the site will support SAFC's
parent company, Sigma Aldrich's research chemicals business by further expanding analytical, packaging, and warehousing facilities.
Rounding up other expansions
Saltigo (Langenfield, Germany) completed a EUR 10 million investment ($14 million) in early 2008 for a CGMP plant in Leverkusen,
Germany, for producing advanced intermediates and APIs. The unit has annual capacity of more than 200 metric tons. In 2008,
Saltigo expanded its early-phase facility in Redmond, Washington. The expansion includes two CGMP-compliant kilo laboratory
systems and a pilot plant for investigational new drugs and intermediates from benchtop to a scale of 400–800 L.
Cambrex (East Rutherford, NJ) opened a new $20-million CGMP large-scale API manufacturing facility in Karlskoga, Sweden, in
March 2009. In 2008, Cambrex added a new 11,500-ft2 facility in Charles, City, Iowa, with five process development/kilo laboratory production suites for high-potency APIs
as well as enhanced facilities for analytical development and quality-control activities. It also expanded its high-potency
micronization facility in Charles City.
Cambrex made other investments in its API business in 2008. It increased the capacity of its API finishing facility in Milan,
Italy, by 20–30% and added to its small-scale development capabilities by acquiring Prosyntest (Tallinn, Estonia).
Hovione (Loures, Portugal) reported sales growth of 21% in the fiscal year ended March 31, 2009, and is expanding as well.
In 2008 Hovione invested in particle-design technologies and in new production lines, at it facilities in Hisyn, China, and
in Portugal. Also in 2008, Hovione acquired from Pfizer (New York) manufacturing facility in Cork, Ireland. The facility
has a 427-m3 of production capacity and spray-drying capabilities.
In July 2009, Novasep (Pompey, France) acquired Henogen (Charleroi, Belgium), a contract manufacturer of bioprocess development
and manufacturing services. In 2008, Novasep added a pilot-scale continuous chromatography unit in its facility in Chasse
sur Rhône France, for supplying enantiomers for clinical supplies. It operates six facilities that manufacture APIs and advanced
intermediates, and four integrate chiral separation services.
Finally, Helsinn (Biasca, Switzerland) is planning to expand the development and manufacturing services at its advanced synthesis
site in Switzerland.
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, pvanarnum@advanstar.com
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