Pharmaceutical Ingredient Suppliers Report on Expansions at CPhI

Milan (Oct. 4)-CPhI Worldwide, the large trade show of suppliers of active pharmaceutical ingredients (APIs), intermediates, and excipients, took on a decidedly international presence.

The growing presence of suppliers from Asia was evident at this year’s show. Roughly 480 exhibitors were from China and 200 from India, based on estimates from the exhibitor list distributed at the show. That combined total eclipsed the number of suppliers from Western Europe (nearly 540) and far surpassed the number of suppliers from North America (nearly 90) and Japan (35).

Several companies unveiled expansion plans at CPhI. SAFC (St. Louis, MO) plans to begin construction of a new CGMP potent active pharmaceutical ingredients (APIs) conjugation suite at its St. Louis manufacturing campus. The new suite will enable the conjugation of highly potent active pharmaceutical ingredients (HPAPIs) to a variety of targeted delivery molecules, including monoclonal antibodies. The new 600-ft² conjugation suite is expected to be operational in late 2007 and will seek “SafeBridge” certification. The suite will accommodate early-stage clinical supplies of potent conjugated APIs, with capabilities to expand production into commercial-scale, handling multikilogram quantities of conjugated HPAPIs per batch.

This investment is in addition to SAFC’s recently announced plans to add HPAPI assets in the United States and Israel and is the third recent expansion in HPAPI manufacturing. These plans include a $4.5-million expansion to introduce additional CGMP pilot-plant and kilo-laboratory capacity at its Madison, Wisconsin, facility and a $12-million, 38,000-ft² expansion program that was completed in 2006. The company is also investing $29 million to expand fermentation capacity at the Sigma-Aldrich Jerusalem, Israel facility, due for completion in 2009.

NPIL Pharma (Mumbai, India) is investing $4 million in its early-phase pharmaceutical development and scale-up business unit at its facility in Ennore, Chennai, India. The company commissioned a new process laboratory in July, and in August, upgraded an existing pilot plant to a CGMP-compliant facility to operate eight reactors with 2200 L of capacity. By the end of the year, NPIL Pharma plans to add eight new reactors with 12,000 L of capacity. The facilities will include a process area for manufacturing APIs and a Class 100,000 cleanroom for final API powder processing and packing. The company also plans to commission a new analytical laboratory in October. The laboratory will include four new science staff groups, increasing the technical team from 25 to potentially 40 personnel.

In other news from CPhI, Avecia Biologics (Manchester, UK) entered into a process development and manufacturing pact with Renovo (Tees Valley, UK) for “Prevascar,” a therapeutic formulation of human recombinant interleukin.

Codexis (Redwood City, CA), which earlier this year acquired BioCatalytics  (Pasadena, CA), introduced four new enzyme panels for use in the pharmaceutical industry. Codexis launched its first panel “Codex” KRED panel for biocatalysis for chiral alcohols in February. The new panels include: acylases for producing chiral amines or alcohols via resolution of amides or esters; ene reductases for producing alpha- and beta-chiral ketones, esters, and nitriles; transaminases for producing chiral amines; and halohydrin dehalogenesases for producing chiral halohydrins, cyanohydrins, amino alcohols, epoxides, and diols.

Halocarbon Products (River Edge, NJ), a producer of specialty fluorochemicals, has doubled its production of hexafluoroisopropanol (HFIP) and is now manufacturing commercial quantities of difluoro compounds. HFIP is an acidic alcohol and can be used as a solvent for various polymers, in solution-phase peptide chemistry, and in making pharmaceutical intermediates.