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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

Unprocessed Bulk and Lot Release Testing

Following the requirement in medicine registration regulatory, a series biosafety testing activities constitutes recombinant antibody product lot release testing which ensures the purify and safety of antibody medicine in clinical application.

To ensure the biosafety and quality of antibody products for the patients who use the medicine, BRC Biotech provides the full-validated lot release testing services for your products, including microbial contamination detection, adventitious virus detection, purity analysis, product impurity detection, etc.

GMP-compliant testing system

Full-validated methodology

Completed project management

Meet the quality requirements of biopharmaceuticals

Comply with the international regulations and guidance

Professional regulatory technical support

BRC Solutions for UPB and Lot Release

BRC Biotechnology provides antibody drug batch release testing that strictly follows GMP procedures and quality management systems, in line with domestic and international regulations for antibody drug biosafety control. To ensure the timely market launch of drugs, we also offer molecular detection techniques for rapid product release, as well as comparative validation with traditional methods.

Category	Testing Item	BRC Method	Regulatory Compliance
Purity	Sterility	Direct Inoculation Method Membrane Filtration Method	USP, EP, ChP
	Bioburden	Membrane Filtration Method	USP, EP, ChP
	Mycoplasma	Agar & Non-agar Cultivation qPCR Rapid Testing	USP, EP, ChP
Safety	Adventitious Viruses	in vitro Indicate Cell-based Assay NGS-based Assay*	USP, EP, ChP
	Retrovirus	Cell-based Infectivity Assay Transmission Electron Microscopy (TEM)	USP, EP, ChP
	Rodent-specific Viruses	qPCR Targeted NGS*	USP, EP, ChP
* NGS-based Assay and Targeted NGS are conducted on BRC NGenius® Platform

BRC Solutions for Product Specific Qualification

In both ICH 02 and the Chinese Pharmacopoeia 2020, Product-related specificity of testing methods are required to be fully Qualified. At least three batches of antibody products should be used for the product specific qualifica- tion before go to market, to evaluated the validated methods is appliable for the dedicated products under com- mercial process. BRC Biotech Providing the PSO as :

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