ASTM WK43739

    New Practice for Process to Remove Virus by Filtration using 20-nm Retentive Viral filter

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    Developed by Subcommittee: E55.04 | Committee E55 | Contact Staff Manager



    WK43739

    1. Scope

    1.1.This practice assures 4 log 10 removal of all viruses greater in size than the PP7 bacteriophage and 5 log 10 removal of large viruses greater than 80 nm, such murine leukemia retrovirus (MuLV). 1.2.The process parameters specified in this practice consistently assure 4 log 10 removal of PP7 bacteriophage by filtration 1.3.This practice is applicable to mAb, IgG fusion, or other recombinant proteins produced from rodent cell lines (for example CHO or murine hybridoma), which do not target retrovirus proteins. The step is performed on cell-free intermediates. 1.4.The 4 log 10 removal claim for small viruses represented by PP7 and the 5 log 10 removal claim for large viruses represented by murine retrovirus, will be utilized in conjunction with other clearance unit operations (for example low pH inactivation or inactivation of virus by surfactant) to assure sufficient total process clearance of potential virus contaminants, which would be supportive of early phase regulatory filings.


    Keywords

    Viral removal, retrovirus, rodent, bacteriophage

    The title and scope are in draft form and are under development within this ASTM Committee.

    Citing ASTM Standards
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    Work Item Status

    Date Initiated:
    10-21-2013

    Technical Contact:
    Robert Steininger II

    Status:
    Draft Under Development