Population
Monoclonal antibody and antibody-related regulatory submissions to FDA
Design
Other
Authors
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Supports viral clearance strategies in mAb manufacturing; extends FDA analyses but leaves open need for process-specific validation.
Analysis of FDA submissions shows that many unit operations for monoclonal antibodies can reliably clear viruses, with average retrovirus log reduction values >4 log(10).
Miesegaes et al. (2010) studied this question.
Synapse has enriched 3 closely related papers on similar clinical questions. Consider them for comparative context: