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 
| 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 | |||
