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ASTM E3042-16

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ASTM E3042-16

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Standard Practice for Process Step to Inactivate Rodent Retrovirus with Triton X-100 Treatment<rangeref></rangeref >
standard by ASTM International, 09/01/2016

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Description

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.

Product Details

Published:
09/01/2016
Number of Pages:
4
File Size:
1 file , 73 KB