Cell bank characterization is a critical quality-control event for cell-derived products. A well-characterized cell bank provides a consistent source of contaminant-free production cells throughout a product's life. And the object of cell bank characterization is to confirm the identity, purity and suitability of the cell substrate for manufacturing use. The testing program varies according to the biological properties of the cells, its cultivation history and available testing procedure. In addition, the test items of master cell bank and working cell bank are different due to requirements.
E. coli bacterial cells are most commonly used production cells. Validated methods for microbial cell line characterization are available in our laboratories. We perform cell bank characterization services according to your different needs, including master cell bank, working cell bank and end of production cell bank. Reliable, rapid and accurate results will be delivered to assist customers to assess the quality of cell banks.
Creative Biogene provides a comprehensive cell bank characterization service for customers to ensure the biosafety and control of biological and biotechnological products. Based on leading-edge facilities and excellent platform, our experienced staff offer a wide range of assays to character cell bank according to ICH guideline Q5D. Services are offered at research grade, or under GLP or GMP regulations.
