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
|
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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 :
