Challenging Standards for Genetic Characterization of Manufacturing Cell Lines

Genetic characterization of mammalian cell lines prior to registrational filing is a regulatory requirement documented for example in ICH Q5D. It is required to demonstrate that a cell line is genetically stable throughout the manufacturing process to ensure manufacture of a consistent product.

Several different approaches for genetic characterization of cell lines are common in the industry.  Firms perform assays internally, or outsource testing to Contract Testing Laboratories. External testing is mostly performed using GMP test methods; for internal testing, there is about an equal split between use of GMP and non-GMP methods.

In this presentation, I’d like to challenge the need of GMP test methods for genetic characterization  of cell lines.

Presented by Jurgen Mullberg, Expert for Development of Mammalian Cell Lines and Therapeutic Proteins, formerly Associate Director – Cell Substrate & Viral Safety at Bristol Myers Squibb

Jurgen has extensive experience in biomedical research and biologics development.  He is a subject matter expert for generation and characterization of mammalian cell lines for therapeutic antibodies and viral glycoproteins, and has deep knowledge of quality and regulatory requirements for manufacturing cell lines and cell culture processes.  He is also an expert for viral safety of manufacturing processes and prevention of viral facility contamination.

Jurgen authored and coauthored 40+ publications and is an inventor on 10+ US patents related to protein therapeutics and antibody engineering. He most recently worked for Novartis and Bristol Myers Squibb.

Jurgen holds a PhD in Biology from RWTH Aachen, Germany.

Followed by a live Question and Answer session