Work Item
ASTM WK78574

New Guide for Best Practices for Microbial Control for Cell Therapeutics

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

Cell Therapy; Microbial Control;

Rationale

It is recognized that the starting material of a cellular therapy may not be free from intrinsic microbial contamination. It is the aim of commercial manufacturers to control and avoid extrinsic contamination sources in order to protect product quality.

The title and scope are in draft form and are under development within this ASTM Committee.

Details

Developed by Subcommittee: E55.06

Committee: E55

Staff Manager: Travis Murdock

Work Item Status

Date Initiated: 10-13-2021

Technical Contact: Scott Drummond

Item: 000

Ballot:

Status: