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Biotechnol Bioeng. 2010 Jun 1;106(2):238-46. doi: 10.1002/bit.22662.

Analysis of viral clearance unit operations for monoclonal antibodies.

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  • 1Office of Biotechnology Products, CDER/FDA, 10903 New Hampshire Ave., Silver Spring, Maryland 20903, USA. george.miesegaes@fda.hhs.gov

Abstract

Demonstration of viral clearance is a critical step in assuring the safety of biotechnology products. We generated a viral clearance database that contains product information, unit operation process parameters, and viral clearance data from monoclonal antibody and antibody-related regulatory submissions to FDA. Here we present a broad overview of the database and resulting analyses. We report that the diversity of model viruses tested expands as products transition to late-phase. We also present averages and ranges of viral clearance results by Protein A and ion exchange chromatography steps, low pH chemical inactivation, and virus filtration, focusing on retro- and parvoviruses. For most unit operations, an average log reduction value (LRV, a measure of clearance power) for retrovirus of >4 log(10) were measured. Cases where clearance data fell outside of the anticipated range (i.e., outliers) were rationally explained. Lastly, a historical analysis did not find evidence of any improvement trend in viral clearance over time. The data collectively suggest that many unit operations in general can reliably clear viruses.

PMID:
20073086
[PubMed - indexed for MEDLINE]

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