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Guaranteed product quality, expert customer support.
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. At Creative Biogene, we perform cell bank characterization services for 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.
Cell bank characterization is a critical quality-control event for cell-derived products. Once a cell line is chosen as the biological source of a product, a well-established cell bank is crucial to assure an adequate supply of equivalent cells exist for use over the entire life span of the product. 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.
|Microbial Cell Bank||Mammalian Cell Bank|
Table 1. Test items of cell bank
As a pioneer of biosafety testing service, Creative Biogene offers international testing methodologies for cell bank characterization. We employ multiple assays to assess cell bank from different aspects, including but not limited PCR, qPCR, next generation sequencing and transmission electron microscopy. All assays are performed to conform to international standards. Custom service is also welcome.