Tag: <span>calicivirus</span>

A Proposed Modeling Approach for Comparing the Heat Inactivation Susceptibility of Viruses

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)…

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Biologics Production

calicivirus feline calicivirus heat inactivation kinetics studies log10 reduction modeling analyses murine norovirus virus inactivation virus sensitivity

Caliciviridae and Vesivirus 2117

In the last few decades, laboratory and therapeutic applications of cell culture-derived biologicals have expanded from their use in diagnostic and research fields to the prevention and treatment of infectious diseases, certain forms of cancer, immunological and congenital conditions, and cell and gene therapy. While significant therapeutic benefits obtained from the use of cell culture-derived biologics (e.g., recombinant proteins, monoclonal antibodies [mAb], and vaccines) are unequivocal, the complexities associated with the manufacture of such products is acknowledged. Primary and continuous cell lines used in the manufacture can be associated with risk of contamination with endogenous retroviruses, latent viruses, or new and emerging agents. Some cell lines, such as Chinese hamster ovary (CHO) cells, have an excellent safety record with no documented safety risks…

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Biologics Production

caliciviridae calicivirus calicivirus 2117 cell culture-derived biologics chinese hamster ovary cho cells emerging agents laten viruses mab monoclonal antibodies perfusion bioprocessing recombinant proteins vesivirus 2117

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

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…

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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

abattoir albumin animal serum animal-derived materials antibody biomedical research blood-derived products calf serum calicivirus cell culture cell medium challenge virus design of efficacy dose mapping fbs fetal bovine serum gamma irradiation heat inactivation isia kgy kilogray microbes mollicute nbcs pathogen reduction product management risk mitigation serum product serum risks spiked serum therapeutic proteins traceability viral reduction whole blood