Viventia’s Winnipeg building infrastructure contains a fully integrated, GMP-compliant production facility comprised of dedicated areas for cGMP production activities, designated as the Fermentation and Purification suites, and a Quality Control laboratory engaged in environmental monitoring, product release and stability testing. A separate Pharmaceutical Development (PD) unit develops manufacturing processes for cGMP production and analytical test methods for Quality Control product release testing.
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Pharmaceutical Development
- Formulation development
- Assay development
- Fermentation and purification process development
- Technology transfer and process scale-up
Fermentation Suite
- Multi-Product facility
- Fed-batch high cell density microbial cultivation
- 1500 L fermenter with a working volume/capacity range of 1000-1200 L
Purification Suite
- Capacity for purification with titers up to 2.0 g/L
Sterile Fill/Finish Suite
Quality Control Laboratory
- Stability Testing on drug product and drug substance
- Analytics/Product Testing
- Environmental Monitoring as per USP
- Raw Material testing Program as per USP
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