1. Viral contamination in biologic manufacture and implications for emerging therapies.
- Author
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Barone PW, Wiebe ME, Leung JC, Hussein ITM, Keumurian FJ, Bouressa J, Brussel A, Chen D, Chong M, Dehghani H, Gerentes L, Gilbert J, Gold D, Kiss R, Kreil TR, Labatut R, Li Y, Müllberg J, Mallet L, Menzel C, Moody M, Monpoeho S, Murphy M, Plavsic M, Roth NJ, Roush D, Ruffing M, Schicho R, Snyder R, Stark D, Zhang C, Wolfrum J, Sinskey AJ, and Springs SL
- Subjects
- Cell Culture Techniques, Drug Industry, Humans, Information Dissemination, Massachusetts, Biological Products standards, Data Collection methods, Drug Contamination prevention & control, Viruses isolation & purification
- 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.
- Published
- 2020
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