Contract Manufacturing Brochure

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Contract R&D and Manufacturing

Bulk Product Manufacturing

Cangene offers its customers considerable expertise in the manufacture of bulk, active pharmaceutical ingredient ("API") for a variety of biopharmaceutical product types, including: plasma-derived and recombinant proteins, plasmid DNA and liposomes. These services are provided at a 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 for 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 1000L scale. The 25,000 square foot biopharmaceutical facility has fermentation and downstream processing capacity up to the 2100L working volume scale.

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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