Contract Manufacturing Brochure

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Contract R&D and Manufacturing

Finished-Product Manufacturing

Cangene offers its customers considerable expertise in the manufacture of finished product for a variety of biopharmaceutical product types, including: plasma-derived and recombinant proteins, plasmid DNA, liposomes and antisense oligonucleotides. These services are provided at a clinical or commercial scale under full cGMP and can be combined with Cangene's bulk API manufacturing capabilities to provide one-stop shopping for its customers.

Cangene has a commercial finished product facility in Winnipeg, Manitoba that is licensed by the U.S. FDA, Heath Canada and the UK MHRA. This facility has over 6,000 square feet of clean-room space and is designed for high-speed vial filling of parenteral products under aseptic conditions.

This multi-product filling facility has the following capabilities:

• vial filling
  • vial size range 2–100 mL
  • batch size 1000–50,000 units
• labeling/packaging/inspection
• lyophilization
  • batch size up to 7,500 units
• full support services
  • batch-release testing
  • stability testing
  • validation services
  • QA and regulatory support

Key equipment in the facility includes:

• Bosch TL filling machine
  • 100–300 units per minute
  • robotic weight checks
  • automatic tray loading
• West capping machine
  • Up to 600 units/minute
• Charles Lapierre labeler
  • vision system for label, lot # and date verification
• Serail Freeze Dryer
  • Fully automated
  • CIP/SIP

Cangene bioPharma, Inc.This link will send you outside of the Cangene website

These services are complemented by the capabilities of Cangene's subsidiary, Cangene bioPharma, Inc.
Visit www.cangenebiopharma.comThis link will send you outside of the Cangene website for more information.

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