Rapid Testing
Our Rapid Testing solutions are designed to streamline biopharmaceutical development and manufacturing by providing fast, accurate, and regulatory-compliant results. Combining advanced NGS-based adventitious testing with ready-to-use residual detection kits, we empower researchers and manufacturers to accelerate product release, ensure biosafety, and maintain the highest standards of quality.
NGenius®: Our platform of NGS technology to deliver compliant, efficient, sensitive adventitious virus detection, accelerated biosafety release of biologics.
CelerQ® Detection Kit: Ready-to-use residuals detection kit for safe and reliable biopharmaceuticals production.
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 | |||
BRC Biotechnology has built comprehensive development and validation capabilities across molecular, microbial, viral, cell, and animal technology platforms, in strict compliance with global pharmacopoeias, regulations, and industry quality standards. Adhering to these rigorous industry quality standards, BRC Biotechnology has achieved a series of prestigious certifications, including the EU GMP Qualified Person (QP) compliance statement, the United States FDA Facility Establishment Identifier (FEI), ISO 9001: 2015 certification, Biosafety Level 2 (BSL-2) accreditation, China Metrology Accreditation (CMA), China National Accreditation Service for Conformity Assessment (CNAS), and more.
