Gamma Irradiation of Animal Serum: An Introduction

by Rosemary J. Versteegen, PhD, Mark Plavsic, PhD, DVM, Raymond Nims, PhD, Robert Klostermann, and Karl Hemmerich
Volume 15, Issue 2 (Summer 2016)

This article serves as an introduction to a series of papers that are being authored under the sponsorship of the International Serum Industry Association with the purpose of establishing best practices for processes employed in the gamma irradiation of animal serum. It is comprised of a discussion about the role of serum in cell culture and the management of the associated risks. Additional articles in the series will address a number of topics of interest to the cell culture community, including, but not limited to: (1) performance of absorbed dose mapping for irradiators; (2) validation of the ef ficacy of pathogen reduction during gamma irradiation of animal serum; (3) comparability evaluation of irradiated serum; (4) product management throughout the irradiation process; and (5) ensuring a quality outcome when using gamma irradiation. The intent of the series is to increase awareness of the scientific community regarding the conduct of gamma irradiation and the strengths and limitations of this serum treatment approach for achieving the goals of adventitious agent risk mitigation...

Versteegen R, Plavsic M, Nims R, Klostermann R, Hemmerich K. Gamma irradiation of animal serum: an introduction. BioProcess J, 2016; 15(2): 5–11.

Posted online July 30, 2016.