Risk Assessment and Mitigation Strategies for Production Cell Substrates

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 its exposure during generation and culture 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.

Presented by Jürgen Hubert Blusch, Consultant – Ex-Novartis Senior Expert Cell Line Analytics and Adventitious Agents

Jürgen studied biology at the University of Regensburg, Germany. For his master and PhD thesis, he worked on promoter analysis and signal transduction with experimental work carried out at the Max-Planck-Institute for Biochemistry, Martinsried, Germany. His PhD studies were supported by a Fellowship of the Boehringer Ingelheim Funds.

Focusses of research during his Post-Doc period were mammalian endogenous retroviruses (GSF-Institute for Mammalian Genetics, Neuherberg, Germany), D-type adenoviruses (Gene Center, Ludwig Maximilians-University, Munich, Germany) and finally cross-species virus transfer during xenotransplantation of pig organs (Max-von-Pettenkofer-Institute, Dep. of Virology). His scientific work is documented in various scientific publications in peer-reviewed journals. For many years, Jürgen was Principal Fellow / Senior Expert Cell Line Analytics and Adventitious Agents within Novartis Pharma TRD Biotechnology Development and associated Quality Control and Quality Assurance units. In this role, he was contributing as Subject Matter Expert for viral and TSE safety of biotech products (recombinant proteins produced in mammalian and microbial cells, cell and gene therapy applications). Prior to this, he was serving as Biosafety Officer and was heading the Cell Substrate Analytics group responsible for genetic and adventitious agents testing of production cell banks and bulk harvests for more than 10 years. In the context of adventitious agents testing, he had qualified as supportive and lead auditor. He had been invited to join the WHO Study Group on Cell Substrates for updating WHO TRS878 and to the PDA core team for the consultation of the European Guideline for Viral Safety of Investigational Products

Followed by a live Question and Answer session