This worksteam is working to produce a consensus on modular claims for viral clearance.
There is no standard approach to viral clearance
Considerable resources and multiple problems are associated with viral clearance in the biopharmaceutical industry. Failure to standardize the definition of ‘worst-case’ conditions can result in:
- Agreed steps for modular/generic claims have limited value
- Process changes during the product development lifecycle often trigger viral clearance studies by default to avoid regulatory risks
Developing an industry reference point for worse case conditions
In this workstream members are developing an industry reference point for companies and regulatory agencies considering how to address viral clearance for different process changes. Members have the opportunity to harmonize worst-case conditions are defined and build better understanding and alignment with ICH Q5a changes.
Viral Clearance deliverables
More related workstreams
Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.
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