Tag: <span>cell culture</span>

Viral safety and viral clearance evaluation are high-profile areas for product safety. Regulators are keenly focused on viral safety and expect high-quality data to support it, particularly for IND and BLA approvals. Familiarity with process and regulatory requirements, as well as expertise in the key areas of viral clearance, are essential for strategic planning and can yield savings in time, effort, and money…

Biologics Production Manufacturing Regulatory

The characterization of a batch cell culture process to produce a monoclonal antibody from a GS-NS0 mouse myeloma cell line is described. Productivity and cellular metabolism were monitored during scale-up to both characterize the process and aid in assessing cell culture stability. During fermentation scale-up studies, it was found that as culture generation number increased, productivity declined. In both flask and bioreactor cultures, declining production started abruptly at approximately generation 60. In this study, we assessed whether the decline in productivity was due to genetic instability of the cell line, which resulted in the generation of a non-producer sub-population, or a shift to a less productive state of cellular metabolism…

Biologics Production

Apoptosis is an essential biological process that has been conserved among eukaryotic organisms throughout evolution. Apoptosis, or programmed cell death, is necessary for embryological development, tissue homeostasis, immune system maintenance and development, and as a defense mechanism against the progression of cancer and viral infection. With the advent of biotechnology and the development of associated molecular biology techniques such as recombinant DNA technology and mammalian cell culture, tissues can be extracted from organisms and have their cells cultured as single cell suspensions or adherent monolayers. Therefore, these cultures can function as living production facilities for antibodies, recombinant glycoproteins, vaccines, hormones, growth factors, and more. However, the cell’s ability to control its own death is not lost upon its manipulation from the organism to culture. Consequently, apoptosis, which is so fundamentally important in-vivo, becomes a detriment to biochemical manufacturers in-vitro…

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