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Cell Substrate Characterization

Cell substrate is an important raw material in biologics production. It is categorized as primary cell, diploid cell, stem cell and continuous cell lines in accordance with the origins and characteristics. To ensure the quality of biological products, it requires the full understanding of the cell characteristic and reduction of exogenous agent presence in the cell lines. Comprehensive cell line characterization will bring high quality and safety to biological products.

Strategy for Cell Substrate Characterization

The cell substrate characterization should be fully considering the cell properties, product characterization and the regulatory requirements. Cell line used for biopharmaceuticals should be tested for cell identity, free of culturable bacteria, fungi, mycoplasma and infectious viruses, including potential pathogens. Animal pathogens, which is not normally found in the cell substrate, should be considered as well as endogenous retroviruses.

BRC solution for cell substrate characterization

BRC Biotech provides comprehensive cell line characterization, raw materials, bulk harvest and drug product testing. We cover antibody products, gene cell therapy, vaccines and other applications. We provide:

Category	Testing Item	BRC Method	Regulatory Compliance
Viability	Cell Vialbility	Cell Counting
Viability	Cell Morphylogy	Microscopic Examination
Identity	CO1 Barcoding	Multiplex PCR Sanger Seqencing	USP, EP, ChP
Purity	Sterility	Direct Inoculation Method Membrane Filtration Method Rapid Ster	USP, EP, ChP
	Mycoplasma	Agar & Non-agar Cultivation qPCR Rapid Testing	USP, EP, ChP
	Mycobacterium	in vitro Indicate Cell-based Assay in vivo Assay NGS-based Assa
Safety	Adventitious Viruses	in vitro Indicate Cell-based Assay in vivo Assay NGS-based Assa	USP, EP, ChP
	Retrovirus	Cell-based Infectivity Assay Transmission Electron Microscopy (TEM) PERT Assay	USP, EP, ChP
	Rodent-specific Pathogens	Antibody Production Test (MAP, HAP, RAP) Rodent Pathogen qPCR Panel Targeted NGS*	USP, EP, ChP
	Bovine & Porcine Pathogens	Cell-based Infectivity Assay Bovine & Porcine Pathogens qPCR Panel	9CFR
* NGS-based Assay and Targeted NGS are conducted on BRC NGenius® Platform