Genetic characterization of cell banks: a regulatory requirement
Recorded Thursday 30 June 2022
Recombinant proteins such as monoclonal antibodies make up most of the biologics available on the market today. Although several expression platforms exist, Chinese hamster ovary (CHO) cells remain by far the most popular cell factory in the pharmaceutical industry. However, CHO cells are also notorious for undergoing a constant and high-rate rearrangement, due to the plasticity of their genome. This, in turn, renders it a source for instability during the bioproduction process.
Furthermore, with an increasing number of complex antibody formats entering the industrial pipelines, their associated production and quality assurance processes also become more challenging. As a case in point, bispecific antibody manufacturing will require the integration of multiple genes and typically involves highly homologous vector sequences. Therefore, genetically discriminating integration sites of each chain variant can prove to be complex.
All in all, as demand for these biological therapeutics surges, manufacturing processes must rapidly adapt and constantly optimize to safeguard stable product quality. To this end, our proprietary genetic screening assays can help you and your team streamline cell line development (CLD) processes to mitigate risks and accelerate early phase testing.
Expect to learn more about:
- Overview of gene editing techniques used in (CHO) cell line development
- Comparison of conventional vs. new technologies to output all essential genetic characteristics
- How to eliminate contaminated (CHO) clones (i.e. those that harbor transgene mutations) early in the CLD process
- Complying with the stringent regulatory requirements mandated by the FDA/EMA