Cell line characterization is a key step in ensuring the safety of biopharmaceutical products with the aim of confirming the identity, purity, genetic stability and tumorigenicity of cell lines. This characterization can ensure that the source of the cell line is authentic and free from contamination, undesirable cells and foreign factors such as bacteria, fungi, mycoplasmas, mycobacteria and viruses. International regulatory guidelines such as ICH (Q5A, Q5B, Q5D), EP and USP for cell lines characterization mainly focus on three areas:
1. Source history and generation of cell lines
2. Establish characteristics and tests of cell line identity, purity and genetic stability
3. The banking procedures of the cell line
Creative Biolabs has extensive experience in the cell bank characterization for biopharmaceutical and vaccine production. We offer a wide range of services to characterize cell banks, develop and design scientifically-validated and proven cell line characterization testing methods.
According to document ICH Q5D ‘Quality of Biological Products: Derivatives and Characterization of Cellular Substrates for the Production of Biotechnology/Biological Products’, Creative Biolabs performs cell bank characterization on the following cell lines:
Eukaryotic and prokaryotic cell banks represent a huge potential value throughout the life of the product. With years of experience and a GMP-qualified laboratory, Creative Biolabs’ cell bank characterization ensures that your biological production process complies with international guidelines.
For more details, please feel free to contact us for project quotations and more detailed information.
For lab research only, cannot be used for any clinical use.