Gamma Irradiation of Animal Serum: General Regulatory Environment and Process Controls

by Greg Hanson, Bart Croonenborghs, Mara Senescu, Huw Hughes, Raymond Nims, and Rosemary Versteegen
Volume 18, Open Access (February 2019)

This is the sixth and last in a series of articles describing and demystifying the processes involved in the gamma irradiation of serum. This serum treatment is intended to mitigate the risk of introducing adventitious contaminants into cell cultures. In this article, we discuss the regulatory environment under which gamma irradiation of serum is performed, and provide additional details on best practices for documentation of the irradiation process, selection of the contract irradiator, evaluation of risk versus benefit needed to arrive at the radiation dose range to be used, as well as an understanding of the level of remaining risk following irradiation at that dose range. Gamma irradiation should not be viewed as a means of totally eliminating risk, but rather as a means of reducing the risk of introducing adventitious agents into cell cultures. A balance must be achieved between the desire to eliminate all adventitious contaminants, and the need to retain the desired performance characteristics of the serum, once irradiated...

Hanson G, Croonenborghs B, Senescu M, Hughes H, Nims R, Versteegen R. Gamma irradiation of animal serum: general regulatory environment and process controls. BioProcess J, 2019; 18.

Posted online February 11, 2019.