Shenzhen BORUI Bioanalytical Platform
- Shenzhen BORUI Pharmaceutical Technology is currently building a comprehensive and state-of-the-art bioanalytical center for biological and chemical drugs, aiming to provide first-class bioanalytical services in the following areas (including but not limited to): PK/TK quantitative analysis, immunogenicity testing (e.g. screening, confirmation and characterization of anti-drug antibodies [ADAs]) and biomarker detection; chemical PK/TK quantitative analysis.
- Our Center will meet the requirements of cGLP (as well as The Organisation for Economic Co-operation and Development [OECD] and other equivalent standards) and will support GLP bioanalysis of PK/PD, immunogenicity and biomarker samples from all phases of clinical studies; as well as non-GLP and preclinical animal PK/PD, toxicity and immunogenicity testing samples.
- Our center will install, certify, and maintain many types of bioanalytical instruments:
- For biological drugs: e.g. ELISA, MSD®, Gyrolab® , SIMOATM, etc.
- For chemical drugs: AB Sciex 4500, 5500 and 6500 (QQQ, or Q-Trap), etc.
- The Bioanalytical Center will be staffed by highly trained and experienced analysts, scientists and quality control personnel; with the ultimate goal of providing superb quality service to our customers.
- We eagerly look forward to collaborating deeply with all pharmaceutical companies developing biologics and chemical drugs in South China to accelerate the discovery and development of biologics and chemical drugs to benefit patients worldwide with unmet medical needs.