Cell Bank Characterization

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
Identify	Gram Staining Test 16S rRNA Sequencing E.coli Strain Identify Testing API 20 Test	Morphological Analysis STR Analysis Karyology Barcode Analysis Isoenzyme Analysis DNA Fingerprinting
Genetic Stability	Copy Number Determination Restriction Endonuclease Analysis Retention of Selectable Marker Retention of Recombinant Construct DNA/RNA Sequencing	Copy Number Determination Restriction Map Analysis Retention of Selectable Marker Retention of Recombinant Construct DNA/RNA Sequencing
Purity	Bacterial and Fungal Impurity Test Bacteriophage Testing Microbiology Testing	Sterility Testing Microbiology Testing Mycoplasma Testing Adventitious Agents Virology Testing Retrovirus Testing
Viability	Cell Viability
Tumorigenicity		Tumorigenicity Test

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.

References:

ICH Topic Q 5 D Quality of Biotechnological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products.
FDA: Points to consider in the characterization of cell lines used to produce biologicals, 1993
FDA: Guidance for industry, Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications, 2010

* For research use only. Not intended for any clinical use.

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