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.
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