ASTM WK36552

    New Practice for Process for Inactivation of Retrovirus by pH

    (What is a Work Item?)

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



    WK36552

    1. Scope

    This Standard will be developed to specify the process for a manufacturing viral kill step that uses a reduction of the process pH and a subsequent hold at that pH before additional pH adjustment and carrying the product forward to a subsequent purification step. This viral kill step is incorporated into the purification train to reduce the viable retrovirus that potentially could be in the process as the result of using mammalian cells as the production cell line for a biologic pharmaceutical drug substance. For this Standard, the primary variables specified are the type of buffer, the buffer composition, the pH, and the extent of time that the process solution is exp! ! ! osed to the lower pH before be re-adjusted to a new pH Viral clearance studies are performed regularly in the biopharmaceutical industry. This standard would facilitate both standardization of the practice, as well as reduce the burden for the industry. The standard will generate a practice in place of the retrovirus clearance studies. Users: pharmaceutical industry, regulatory agencies


    Keywords

    retrovirus, inactivation, viral, clearance
    Citing ASTM Standards
    Back to Top
    Work Item Status

    Date Initiated:
    02-21-2012

    Technical Contact:
    Ali Afnan

    Status:
    Approved