cGMP Biologics Manufacturing Services

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•Fact Sheet: cGMP Biologics Manufacturing Services

Therapure has 30,000 ft2 (2,800 m2) of cGMP manufacturing space including clinical and commercial scale production. Our modern facility provides us with the flexibility to meet our clients' contract development and manufacturing requirements and the capacity to scale up production from mg to kg.

Strategic placement and use of clean room panels, roll-up doors and removable exterior walls enables Therapure to create manufacturing suites customized to our clients' product-specific needs. Therapure operates a range of classified suites from Grade A (Class 100:ISO 5) through Grade C (Class 10,000:ISO 7).

As an integrated CDMO, Therapure brings the skills of a diverse group of seasoned professionals responsible for all aspects of biopharmaceutical manufacturing to client projects. Our team is also highly experienced in the development and manufacture of protein therapeutics satisfying Canadian, U.S. and European cGMP and regulatory requirements.

Therapure has experience utilizing a variety of different sources of API including:

• Mammalian Cell Culture
• Whole Blood and Plasma
• Primary Cell Culture

Manufacturing capabilities and capacities include:

• Tissue Processing
• Upstream Processing
  • Mammalian cell culture (CHO, HEK-293, Hybridoma, Stem)
  • Master Cell Bank (MCB) creation
  • Microbial processes (through strategic partnerships)
  • Media preparation
• Downstream Processing
  • Purification
    • Chromatography
    • Membrane separation
    • Fraction precipitation
    • Pasteurization
  • Protein modification
    • Conjugation
    • Refolding
    • Enzymatic Conversion
  • Buffer preparation

Click Here To Download:
•Fact Sheet: cGMP Biologics Manufacturing Services