Viral contamination in biologic manufacture and implications for emerging therapies
Name
NatureBiotech.pdf
Description
Accepted version
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312.16 KB
Format
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Author(s)
Barone, Paul
Wiebe, Michael E
Leung, James
Hussein, Islam
Keumurian, Flora J.
Bouressa, James
Brussel, Audrey
Chen, Dayue
Chong, Ming
Dehghani, Houman
Date Issued
April 2020
Journal
Nature Biotechnology
Publisher
Springer Science and Business Media LLC
Citation
Barone, Paul W. et al. "Viral contamination in biologic manufacture and implications for emerging therapies." Nature Biotechnology 38, 5 (April 2020): 563–572. © 2020 The Author(s)
Version
Author's final manuscript
Abstract
Recombinant protein therapeutics, vaccines, and plasma products have a long record of safety. However, the use of cell culture to produce recombinant proteins is still susceptible to contamination with viruses. These contaminations cost millions of dollars to recover from, can lead to patients not receiving therapies, and are very rare, which makes learning from past events difficult. A consortium of biotech companies, together with the Massachusetts Institute of Technology, has convened to collect data on these events. This industry-wide study provides insights into the most common viral contaminants, the source of those contaminants, the cell lines affected, corrective actions, as well as the impact of such events. These results have implications for the safe and effective production of not just current products, but also emerging cell and gene therapies which have shown much therapeutic promise.
MIT Department
Massachusetts Institute of Technology. Center for Biomedical Innovation
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Creative Commons Attribution-Noncommercial-Share Alike
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DOI of Published Version
https://doi.org/10.1038/s41587-020-0507-2
