Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks, Annex 3, TRS No 978

Overview

Full version of  WHO Technical Report Series No. 978

Cell substrates are cells used to manufacture biological products. It is well established that both cell substrates themselves and events linked to cell growth  can affect the characteristics and safety of the resultant biological products. Therefore, a thorough understanding of the characteristics of the cell substrate is essential in order to identify points of concern and to develop a quality control  system that addresses these points.