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Antibody Product
mAb, ADC, RDC, etc.
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The production of antibody drugs involves complex processes. From cell line establishment to process scale-up, quality control at each step critically impacts product safety. To ensure antibody drug safety, it is essential to establish rigorous biosafety evaluation systems, employ advanced detection technologies, and continuously optimize quality control strategies.
Biosafety Strategy for Antibody Production
Antibody Product
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
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
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