Work Item
ASTM WK78574

New Guide for Best Practices for Microbial Control for Cell Therapeutics

1. Scope

This document is intended to recommend control steps to be considered for microbial quality of cell-based therapies


Cell Therapy; Microbial Control;


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.


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