Work Item
ASTM WK65429

New Practice for Process to Remove Retrovirus by Small Virus Retentive Filters

1. Scope

The scope of the Committee shall be the development of standardized nomenclature and definitions of terms, test methods, specifications, and performance standards for the manufacture of pharmaceutical and biopharmaceutical products. The Committee will encourage research in this field and sponsor symposia, workshops, and publications to facilitate the development of such standards. The Committee will promote liaison with other ASTM Committees and other organizations with mutual interests.

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.

Details

Developed by Subcommittee: E55.04

Committee: E55

Staff Manager: Travis Murdock

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: Negative Votes Need Resolution