St. Louis - SAFC, a member of the Sigma-Aldrich Group, has announced the construction completion of two major new protein API facilities at its St. Louis, Missouri manufacturing campus.
A new Biologics manufacturing facility consists of a 25,000 sq. ft. cGMP purification and manufacturing suite for transgenic plant and other non-animal derived protein APIs and a 6,000 sq. ft. facility for purification of animal-derived protein APIs. Validation for commercial operation of this $16 million expansion at the 400,000 sq. ft. St Louis manufacturing campus is expected by mid-year 2007.
"This expansion for SAFC Pharma further reflects our recognized market leadership in cGMP purification of therapeutic proteins from natural sourced material," said SAFC President Frank Wicks. "The expanded capacity responds to the increased demand for large-scale supply and will meet late-stage clinical trial and commercial manufacturing needs for both transgenic and naturally-sourced APIs."
The Biologics facility features some of the largest extraction and purification suites of their kind in the industry. The Class 100,000 (ISO 8) and Class 10,000 (ISO 7) clean rooms will accommodate multiple one-meter chromatography columns and ultrafiltration operations, with API target quantities in the five-kilogram range. Also featured is a Class 10,000 (ISO 7) lyophilization suite.
Completely separated to prevent potential cross-contamination, the facility for animal-derived API purification also features Class 100,000 (ISO 8) and Class 10,000 (ISO 7) clean rooms. These will also include multiple one-meter chromatography columns and ultrafiltration operations to give API quantities in the five-kilogram range.
Both facilities are supported by SAFC Pharma's extensive process development, quality control and quality assurance capabilities and teams in St. Louis.