Viral contamination in biologic manufacture and implications for emerging therapies
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 r...
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| Format: | Article |
| Language: | English |
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Springer Science and Business Media LLC
2021
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| Online Access: | https://hdl.handle.net/1721.1/131201 |
| _version_ | 1826217362485936128 |
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| author | Barone, Paul Wiebe, Michael E Leung, James Hussein, Islam Keumurian, Flora J. Bouressa, James Brussel, Audrey Chen, Dayue Chong, Ming Dehghani, Houman Gerentes, Lionel Gilbert, James Gold, Dan Kiss, Robert Kreil, Thomas R. Labatut, René Li, Yuling Müllberg, Jürgen Mallet, Laurent Menzel, Christian Moody, Mark Monpoeho, Serge Murphy, Marie Plavsic, Mark Roth, Nathan J. Roush, David Ruffing, Michael Schicho, Richard Snyder, Richard Stark, Daniel Zhang, Chun Wolfrum, Jacqueline M Sinskey, Anthony J Springs, Stacy |
| author2 | Massachusetts Institute of Technology. Center for Biomedical Innovation |
| author_facet | Massachusetts Institute of Technology. Center for Biomedical Innovation Barone, Paul Wiebe, Michael E Leung, James Hussein, Islam Keumurian, Flora J. Bouressa, James Brussel, Audrey Chen, Dayue Chong, Ming Dehghani, Houman Gerentes, Lionel Gilbert, James Gold, Dan Kiss, Robert Kreil, Thomas R. Labatut, René Li, Yuling Müllberg, Jürgen Mallet, Laurent Menzel, Christian Moody, Mark Monpoeho, Serge Murphy, Marie Plavsic, Mark Roth, Nathan J. Roush, David Ruffing, Michael Schicho, Richard Snyder, Richard Stark, Daniel Zhang, Chun Wolfrum, Jacqueline M Sinskey, Anthony J Springs, Stacy |
| author_sort | Barone, Paul |
| collection | MIT |
| description | 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. |
| first_indexed | 2024-09-23T17:02:27Z |
| format | Article |
| id | mit-1721.1/131201 |
| institution | Massachusetts Institute of Technology |
| language | English |
| last_indexed | 2024-09-23T17:02:27Z |
| publishDate | 2021 |
| publisher | Springer Science and Business Media LLC |
| record_format | dspace |
| spelling | mit-1721.1/1312012022-10-03T10:00:45Z Viral contamination in biologic manufacture and implications for emerging therapies Barone, Paul Wiebe, Michael E Leung, James Hussein, Islam Keumurian, Flora J. Bouressa, James Brussel, Audrey Chen, Dayue Chong, Ming Dehghani, Houman Gerentes, Lionel Gilbert, James Gold, Dan Kiss, Robert Kreil, Thomas R. Labatut, René Li, Yuling Müllberg, Jürgen Mallet, Laurent Menzel, Christian Moody, Mark Monpoeho, Serge Murphy, Marie Plavsic, Mark Roth, Nathan J. Roush, David Ruffing, Michael Schicho, Richard Snyder, Richard Stark, Daniel Zhang, Chun Wolfrum, Jacqueline M Sinskey, Anthony J Springs, Stacy Massachusetts Institute of Technology. Center for Biomedical Innovation 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. 2021-08-25T15:47:48Z 2021-08-25T15:47:48Z 2020-04 2018-04 2021-08-11T15:12:56Z Article http://purl.org/eprint/type/JournalArticle 1087-0156 1546-1696 https://hdl.handle.net/1721.1/131201 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) en http://dx.doi.org/10.1038/s41587-020-0507-2 Nature Biotechnology Creative Commons Attribution-Noncommercial-Share Alike http://creativecommons.org/licenses/by-nc-sa/4.0/ application/pdf Springer Science and Business Media LLC Prof. Sinskey |
| spellingShingle | Barone, Paul Wiebe, Michael E Leung, James Hussein, Islam Keumurian, Flora J. Bouressa, James Brussel, Audrey Chen, Dayue Chong, Ming Dehghani, Houman Gerentes, Lionel Gilbert, James Gold, Dan Kiss, Robert Kreil, Thomas R. Labatut, René Li, Yuling Müllberg, Jürgen Mallet, Laurent Menzel, Christian Moody, Mark Monpoeho, Serge Murphy, Marie Plavsic, Mark Roth, Nathan J. Roush, David Ruffing, Michael Schicho, Richard Snyder, Richard Stark, Daniel Zhang, Chun Wolfrum, Jacqueline M Sinskey, Anthony J Springs, Stacy Viral contamination in biologic manufacture and implications for emerging therapies |
| title | Viral contamination in biologic manufacture and implications for emerging therapies |
| title_full | Viral contamination in biologic manufacture and implications for emerging therapies |
| title_fullStr | Viral contamination in biologic manufacture and implications for emerging therapies |
| title_full_unstemmed | Viral contamination in biologic manufacture and implications for emerging therapies |
| title_short | Viral contamination in biologic manufacture and implications for emerging therapies |
| title_sort | viral contamination in biologic manufacture and implications for emerging therapies |
| url | https://hdl.handle.net/1721.1/131201 |
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