Risk Assessment and Mitigation Strategies for Production Cell Substrates - Seguridad Mania.com - España y América Latina

Specific risks of production cell lines will be discussed, in particular rodent cell lines often used for the production of recombinant proteins and human cell lines for the production of viral vectors for use in gene and cell therapy. The topics covered will include virus and TSE risk of a cell line considering its nature and origin and exposure during generation and culture of cell lines to materials of concern, but also implications due to cell line clonality and homogeneity issues. Depending on the outcome of a cell line risk assessment, possible mitigation strategies and risk-based analytical quality strategies are proposed to ensure the safety of a cell substrate for production of biological drug substances for use in humans.