This Standard will be developed to specify the process parameters required for enveloped virus inactivation through addition of a detergent during the manufacture of biological pharmaceutical drug substances. This Standard would apply to recombinant proteins produced from rodent cell lines. This viral inactivation step is performed on a cell-free intermediate to reduce the level of viable enveloped virus that could potentially be found within biological pharmaceutical drug substance production processes. This Standard would be utilized in conjunction with other clearance unit operations to assure sufficient total process clearance of enveloped virus. For this Standard, the primary parameters specified are detergent type, detergent concentration, contact time (the amount of time the biological drug and the biological drug matrix are exposed to detergent), biological drug matrix (i.e. buffering system), inactivation temperature, and biological drug concentration.
This standard practice will benefit the producers of biological pharmaceutical drug substances and their patients by providing parameters that assure consistent enveloped virus inactivation using detergent in biological pharmaceutical drug substances manufactured from rodent derived cells (i.e. CHO or murine hybridoma). This standard practice will replace viral clearance testing of detergent removal in early stage clinical drug products that do not yet require the level of validation needed in late stage and/or commercial drug products. This standard practice will be used by companies manufacturing recombinant biological therapeutics (i.e. monoclonal antibodies, IgG fusion proteins, or other recombinant proteins) produced in rodent cell lines.
Keywordsenveloped virus, detergent inactivation, biological pharmaceutical drug substance, recombinant protein, monoclonal antibody, IgG fusion protein, viral clearance, retrovirus, biopharmaceutical manufacturing
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
Ballot Item Approved as E3042-2016 and Pending Publication