1.1.This practice assures a specific log removal of large viruses greater than 80 nm, such as murine leukemia retrovirus (MuLV). 1.2.The log removal claim is based on data ib the removal of bacteriophage by a standard filtration tests for a specific filter. If only small bacteriophage data is available, the removal is a conservative estimate of potential removal of retrovirus by a filter 1.3.The process parameters used in the filtration must represent the worst case values of the production process if the log removal of the MuLV is to be assured. 1.4.Greater removal may be achieved and claimed if a specific validation is done with a MuLV and the specific process parameters used in a particular process. 1.5.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. 1.6.The log 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.
KeywordsViral removal, retrovirus, rodent, bacteriophage
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
Robert Steininger II
Draft Under Development