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.
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