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Viral safety and clearance evaluation--implications for process change and comparability
1Pacific BioDevelopment, Burlingame, CA 94010, USA. marshall@pacbiodev.com
Developments in Biologicals
|November 19, 2002
Summary
Ensuring virological safety in cell-based biologicals requires rigorous testing of raw materials, effective virus clearance steps, and final product testing. Process changes and column reuse must be evaluated to maintain safety throughout development and post-licensure.
Area of Science:
- Biotechnology
- Virology
- Process Development
Background:
- Cell-based biologicals require stringent virological safety measures.
- A multi-faceted approach is essential for ensuring safety.
Purpose of the Study:
- To evaluate the impact of process changes on virus safety.
- To assess the effect of column reuse on virus clearance efficacy.
Main Methods:
- Implementing a three-pronged approach: raw material testing, virus clearance steps, and lot-by-lot testing.
- Evaluating process modifications and column reuse in the context of viral safety.
Main Results:
- Process changes can impact established virus clearance steps.
- Column reuse requires careful assessment to ensure continued viral clearance.
Conclusions:
- Continuous evaluation of process changes and column reuse is critical for maintaining virological safety.
- Adherence to robust safety protocols is paramount from development through post-licensure stages.