Tag: <span>heat inactivation</span>

Heat inactivation is dependent both on temperature and time at temperature, making inter-assay and intervirus comparisons of heat sensitivity of viruses problematic. Historically, heat inactivation data for pathogens, including viruses, have been evaluated by determining decimal reduction value ([D] the time required to inactivate 1 log10 of the organism at a given temperature) and the incremental temperature required to decrease the D by 1 log10 (z). We recommend the use of a straightforward approach for extrapolating heat inactivation (i.e., inactivation vs. time at fixed temperature) data from measured to non-measured temperatures that is based not on the z value, but on a power function fit of the D vs. temperature plots. There needs to have been at least three temperatures evaluated in the inactivation vs. time kinetics studies in order to conduct these modeling analyses. For inter-assay and inter-virus comparisons of heat inactivation sensitivity, we propose the use of two modeled parameters: (1) temperature required to inactivate 1 log10 of virus in 0.5 minutes; and (2) time required for 1 log10 reduction in infectivity at 80°C. By using both modeled parameters, we have calculated consensus heat inactivation values for two caliciviruses (feline calicivirus and murine norovirus)…

Biologics Production

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…

Biologics Biologics Production Bioreactor Scale-Up Cell & Gene Therapy Cell Lines Fed-Batch Bioreactor Process HEK293 Mammalian Cell Culture Manufacturing Regulatory Viral Reference Materials Viral Vectors

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 efficacy 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.

Biologics Biologics Production Bioreactor Scale-Up Cell & Gene Therapy Cell Lines Fed-Batch Bioreactor Process HEK293 Mammalian Cell Culture Manufacturing Regulatory Viral Reference Materials Viral Vectors