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Cell and Gene Therapy

Viral Vector, Oncolytic Virus, Stem Cell, CAR-T/TCR-T, CAR-NK, TIL, etc

Cell and gene therapies (CGT) are advanced biological products including viral vectors, oncolytic viruses, stem cells, CAR-T/TCR-T, CAR-NK, and tumor-infiltrating lymphocytes (TILs). Due to their unique mode of action (MOA), the manufacturing processes of these emerging biologics are more complex compared to traditional biologics and small molecule therapeutics. They require stringent GMP controls while experiencing rapid market growth. To ensure final product quality, developing science-driven, process-informed biosafety testing strategies that meet global regulatory standards is essential.

Biosafety Strategy for Cell and Gene Therapy

Cell and Gene Therapy

Cell Line 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 Line Characterization

The cell line 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 Line 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 Viability	Cell Counting
Viability	Cell Morphylogy	Microscopic Examination
Identity	CO1 Barcoding	Multiplex PCR Sanger Sequencing	USP, EP, ChP
Purity	Sterility	Direct Inoculation Method Membrane Filtration Method Rapid Sterility	USP, EP, ChP
	Mycoplasma	Culture method Indicator cell culture method Nucleic acid amplification test (NAT) method qPCR Rapid Testing	USP, EP, ChP
	Mycobacterium	in vitro Indicate Cell-based Assay in vivo Assay NGS-based Assay
Safety	Adventitious Viruses	in vitro Indicate Cell-based Assay in vivo Assay NGS-based Assay	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 P	9CFR
* NGS-based Assay and Targeted NGS are conducted on BRC NGenius^® Platform

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