The Viral Clearance Team have generated and reviewed a benchmarking survey on the experiences in applying prior knowledge and modular viral clearance claims to health authority regulatory submission for clinical programs and licensure applications. The results and key...
The Worst-Case Conditions sub-team of the BioPhorum Development Group Viral Clearance team produced a poster presentation based on their analysis of the worst-case conditions benchmarking survey, which was presented at BPI East and will support their publication...
The BioPhorum Development Group Viral Clearance Worst-Case Conditions sub-team has reviewed and analyzed the worst-case conditions benchmarking survey. Produced in 2019, the results of this survey, along with the team’s analysis, are providing input to a paper that...
This white paper provides an overview of current practices for the qualification and refinement of small-scale models (SSM) used in the development of biopharmaceutical drug substance manufacturing processes. SSMs are utilized to meet regulatory expectations of:...
