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Cangene has considerable expertise in the manufacture of bulk API for a variety of biopharmaceutical product types including plasma-derived and recombinant proteins, plasmid DNA and liposomes. These services are provided at the clinical or commercial scale under full cGMP.
Cangene operates two commercial API facilities in Winnipeg, Manitoba:
- an FDA-licensed fractionation/filling facility for parenteral drugs; and
- a biopharmaceutical facility capable of manufacturing microbial-derived products up to the kilogram scale.
The 45,000 square foot fractionation/filling facility is designed for the manufacture of plasma-derived hyperimmunes and other parenteral products up to the 1000 L scale. The 25,000 square foot biopharmaceutical facility has fermentation and downstream processing capacity up to the 2100 L working volume scale.
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These multi-product manufacturing facilities are designed to maximize the flexibility of processing operations. Processing capabilities include:
- fermentation
- cell breakage
- chromatography
- centrifugation
- ultrafiltration
- prep scale HPLC
- buffer preparation
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