Validation Process Begins for New SAFC Pharma Protein API Units in Saint Louis

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Reported by Annette Kreuger, Industrial Info Resources (Sugar Land, Texas). SAFC Pharma (Saint Louis, Missouri), a member of the Sigma-Aldrich Group (NASDAQ:SIAL) (Saint Louis, Missouri), has wrapped up construction on a major expansion of its protein purification active pharmaceutical ingredient (API) capacity in Saint Louis, Missouri. The $16 million project added nearly 30,000 square feet of cGMP manufacturing space to Sigma-Aldrich’s 400,000 square foot campus. Completion of validation allowing commercial operations at the new facility is expected to be complete later this year.

The project included the addition of 25,000 square feet of cGMP biologics purification and manufacturing for transgenic plant and other non-animal derived protein APIs. APIs are not a final product per se. They are the essential chemicals/ingredients used in the manufacturing of drug products. In essence, they are what make a drug “work.”

A 6,000 square foot facility for purification of animal-derived protein APIs was also added. The expansion will serve the increased demand for large-scale production capacity, as well as providing late-stage clinical trial and commercial manufacturing for both transgenic and naturally-sourced APIs.

The units feature both Class 10,000 (ISO 7) and Class 100,000 (ISO 8) clean rooms housing multiple one-meter chromatography columns and ultra-filtration operations, with APR production of five-kilograms. A Class 10,000 (ISO 7) lyophilization suite was also added. The extraction and purification suites, some of the largest of their type in the industry, are completely separated to prevent cross-contamination.

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