Risk Analysis of Raw Materials Used in Mammalian Cell Culture Media

by Trish Benton and Thomas C. Thomas
Volume 1, Issue 2 (Summer 2002)

Growth media for mammalian cell culture are complex mixtures of raw materials that include amino acids, vitamins, inorganic salts and a wide variety of other components. The risk of infectious agent transmission, when some of these components are derived directly from animals, is a major concern in the biopharmaceutical industry, and is being actively addressed. However, the risk associated with the use of indirectly, or secondarily, derived animal components is less recognized and addressed. We have developed a classification system to define the contact level that a cell culture medium component has had with animal-derived materials. This classification system has increased the accuracy and reliability of the information we are able to obtain from raw material manufacturers, and is being used as part of a risk assessment analysis for a serum/protein-free media we are moving from development into manufacturing...

Citation:
Benton T, Thomas TC. Risk Analysis of Raw Materials Used in Mammalian Cell Culture Media. BioProcess J, 2002; 1(2): 40-42.