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Call for Articles

Gamma Irradiation of Frozen Animal Serum: Dose Mapping for Irradiation Process Validation

by Bart Croonenborghs, Andy Pratt, Lorraine Bone, and Mara Senescu
Volume 15, Issue 3 (Fall 2016)

The treatment of animal serum by gamma irradiation is performed to mitigate the risk of introducing undesired microorganisms (viruses, mollicutes, or other microbes) into a cell culture. Serum manufacturers and end-users utilize irradiation contractors to perform this process. The irradiation process must be validated, which involves establishing the: (A) minimum dose that achieves the required inactivation of the microorganisms of interest; (B) maximum acceptable dose at which the serum still maintains all of its required functional specifications; and (C) process used by the contract irradiator that allows treatment of the serum product within these defined limits. In the present article, we describe the best practices for qualifying the distribution and magnitude of absorbed dose (performance qualification [PQ] dose-mapping) when serum is gamma irradiated. PQ dose-mapping includes the following: (1) documentation of dose distribution characteristics in defined product load configurations for a specified pathway through the irradiator; (2) assessment of the process capability of the defined product load configurations and irradiation pathway for respecting the dose specification for the serum; and (3) development of a method for routine dose monitoring of the irradiation process with the defined product load configurations and the specified irradiation pathway...

Croonenborghs B, Pratt A, Bone L, Senescu M. Gamma irradiation of frozen animal serum: dose mapping for irradiation process validation. BioProcess J, 2016; 15(3): 7–13.

Posted online November 15, 2016.

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.

Gamma Irradiation of Animal Serum: Validation of Efficacy for Pathogen Reduction and Assessment of Impacts on Serum Performance

by Mark Plavsic, PhD, DVM, Raymond Nims, PhD, Marc Wintgens, and Rosemary J. Versteegen, PhD
Volume 15, Issue 2 (Summer 2016)

The treatment of animal serum by gamma irradiation, for the purpose of mitigating the risk of introducing a pathogen (virus, mollicute, or other microbe) into a cell culture, is a process that has been executed (and perhaps understood) primarily by irradiation contractors utilized by serum manufacturers. The selection of appropriate exposure conditions and irradiation doses is driven by a number of critical factors including: (1) the validation and control of the irradiation process itself; (2) the efficacy of the applied irradiation dose range for inactivating pathogens of interest; (3) determination and control of critical process attributes; (4) the potential impacts of these irradiation dose levels on the serum being irradiated; and finally, (5) the potential impact of irradiated serum on the medicinal product and the associated manufacturing process where serum is ultimately used. In order to increase awareness of these topics throughout the cell culture community, we have addressed these critical factors in the current review...

Plavsic M, Nims R, Wintgens M, Versteegen R. Gamma irradiation of animal serum: validation of efficacy for pathogen reduction and assessment of impacts on serum performance. BioProcess J, 2016; 15(2): 12–21.

Posted online July 30, 2016.


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