Work Item
ASTM WK65429
New Practice for Process to Remove Retrovirus by Small Virus Retentive Filters
1. Scope
1.1 This practice assures 5.0 log10 removal of retrovirus (for example, MuLV). 1.2 This practice is applicable to monoclonal antibody (mAb), immunoglobulin G (IgG) fusion proteins, recombinant proteins, or other proteins produced using mammalian cell lines [for example, Chinese hamster ovary (CHO), murine hybridomas, murine myelomas, or Human Embryonic Kidney (HEK) 293]. 1.3 The step is performed on cell-free intermediates. 1.4 The log removal claim for retrovirus can be used 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 (clinical phase 1 or phase 2b trials) regulatory filings. 1.5 UnitsThe values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. 1.6 Retrovirus removal claim by filtration is limited to small virus retentive filters, as defined in the PDA Technical Report Virus Filtration (1) in the context of this practice.
Keywords
parvovirus; retrovirus; virus removal; MuLV; small virus retentive filter; viral clearance; virus filtration; modular claim; modular retrovirus claim; virus filter
Rationale
The log removal claim for retrovirus will be used 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 (phase 1 or phase 2a) filings.
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
Date Initiated: 10-17-2018
Technical Contact: john schreffler
Item: 001
Ballot: E55.04 (19-04)
Status: Will Reballot Item
Item: 004
Ballot: E55 (20-03)
Status: Will Reballot Item
Item: 002
Ballot: E55 (20-07)
Status: Will Reballot Item
Item: 002
Ballot: E55 (22-06)
Status: At Society Review