The BioPhorum viral clearance team have produced two papers:
- Paper 1: “Retrospective evaluation of low pH viral inactivation and viral filtration data from multiple company collaboration”
- Paper 2: “Retrospective evaluation of cycled resin viral clearance studies – A multiple company collaboration”
For the last three years, the team have completed a short survey on each paper to understand how they have been used and the response of regulators if used to support filings. General feedback is positive that companies are utilizing the recommendations, although, direct correlation of the number of positive replies cannot be concluded as we do not know which companies had responded in previous years. It would be interesting to understand moving forward, what is prohibiting those companies that have not implemented the recommendations yet.
The full results and member feedback is available only to BioPhorum members.