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
Staff Manager: Travis Murdock
Date Initiated: 10-13-2021
Technical Contact: Scott Drummond