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SAFC Cherokee - St. Louis, Missouri Protein Extraction & Purification SAFC Pharma™ has completed construction and validation of two cGMP facilities dedicated to the manufacture of API's from natural-sourced starting materials. These facilities are designed to meet current industry standards for biologics while maintaining complete segregation of recombinant and natural proteins produced in either plant or animal raw materials. SAFC® has taken a leading position in the transgenics industry by commercializing the first transgenic protein TrypZean™ which is a recombinant Trypsin produced in corn. With the company’s three new facilities, SAFC offers its customers some of the largest-scale contract API manufacturing services for Biologics available to the market. Capabilities Highlights: Completely segregated plant and animal protein processing facilities eliminates potential cross-contamination A large-scale extraction and clarification facility that is capable of processing multi-ton quantities of biomass per day. Large Class 100,000 (ISO 8) and Class 10,000 (ISO 7) Clean Rooms capable of handling up to one meter chromatography operations Bulk API Lyophilization and packaging operations.     "Animal-free" API Manufacturing: - See Virtual Tour UPSTREAM Extraction Room – Controlled, not classified (CNC) Tanks:  3 x 2,500 L Extraction Tanks and 1 x 7,000 L Buffer Tank Clarification Room – Controlled, not classified (CNC) Tanks:  1 x 3,200 L and 2 x 2,000 L Distributive Control Systems (DCS) Buffer Preparation Room – Pre-weigh - ISO08 Tanks: 2x 2,500L Buffer Tanks     DOWNSTREAM DSP 1 - Iso 8 – (Class 100,000) processing suite -- 1054 sq. ft. DSP 1 - Iso 7 – (Class 10,000) processing suite -- 660 sq. ft. Unidirectional flows, separate personnel / equipment entry airlocks, smooth cleanable walls and ceilings, minimize process drains and floor drains.     LYOPHILIZATION 200 L Lyophilization Room - Iso 7 – (Class 10,000 w/ a Class 100 area) - 255 sq. ft. 20 L Lyophilization Room - Iso 7 – (Class 10,000 w/ a Class 100 area)   Animal Origin API Manufacturing: - See Virtual Tour DSP 1 - Iso 8 – (Class 100,000) Processing Suite  -- 940 sq. ft. DSP 2 - Iso 7 – (Class 10,000) Processing Suite -- 600 sq. ft. Clean Room Iso 8 – Room number DSP 1 Support Rooms: - See Virtual Tour Process Development Lab Quality Control Lab     Quality Manager 3300 South Second St. St. Louis, MO 63118 Tel: 314-286-6689 Tel: 800-244-1173   Schedule a Site Audit   Request Quality Information   ISO 9001:2000 Certificate 229k pdf   FDA Registration 1937990 (Drug) (65k PDF)   FDA Registration 1937990 (Device) (86k PDF)