Recombinant proteins such as hormones, growth factors, cytokines, and monoclonal antibodies play an important role in modern medicine, being used to treat a variety of disease. Mammalian cell expression systems are the ideal choice to produce eukaryotic proteins as they enable post-translational modifications which are crucial for the correct folding of many eukaryotic proteins. Human embryonic kidney 293 (HEK293) cells are the predominant hosts for expression of recombinant proteins and are used for stable expression of proteins.
Creative Bioaray ChromoGenetics has extensive experience in characterization of cGMP HEK293 cell banks used in production of biologic drugs. Our HEK293 cell line characterization allows you to efficiently streamline your cGMP-compliant manufacturing processes and accelerate toward successful commercialization. Furthermore, our reporting fulfils FDA and EMA regulatory requirements for pharmaceuticals for human use (ICH guidelines Q5B and Q5D, CTD Quality module, section 3.2.S.2.3).
According to document ICH Q5D ‘Quality of Biological Products: Derivatives and Characterization of Cellular Substrates for the Production of Biotechnology/Biological Products’, Creative Bioarray performs HEK293 cell bank characterization on the following cell lines:
Cell Bank characterization is an essential step in ensuring the safety of biopharmaceutical products with the aim of confirming the identity, purity and genetic stability of cell lines. This characterization can ensure that the cell banks are free of contaminants and are able to provide a solid, stable foundation to continue production process years down the road. International regulatory guidelines such as ICH (Q5A, Q5B, Q5D), EP and USP for cell lines characterization mainly focus on four areas:
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