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ASTM E3042 PDF
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Standard Practice for Process Step to Inactivate Rodent Retrovirus with Triton X-100 Treatment
| Published by | Publication Date | Number of Pages |
| ASTM | 09/01/2016 | 4 |
ASTM E3042 – Standard Practice for Process Step to Inactivate Rodent Retrovirus with Triton X-100Treatment
1.1 This practice assures effective inactivation of ≥4 log10 of infectious rodent retrovirus (that is, reduction from 10 000 to 1 infectious rodent retrovirus or removal of 99.99 % of infectious rodent retroviruses) in the manufacturing processes of monoclonal antibodies or immunoglobulin G (IgG) Fc fusion proteins manufactured in rodent-derived cell lines that do not target retroviral antigens. Rodent retrovirus is used as a model for rodent cell substrate endogenous retrovirus-like particles potentially present in the production stream of these proteins.
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