Quality Control and Product Characterization
Quality analysis services at all stages of drug development, including physicochemical analysis, cell activity analysis and binding analysis
Based on the structure and process complexity of pharmaceutical proteins, high-quality structure and impurity analysis can strongly support drug development, manufacturing, and stability research. OPM provides customers with one-stop biomacromolecular drug quality control services, including physical and chemical analysis, cell activity analysis and binding analysis, etc., meeting the analysis needs of various stages from drug discovery to commercial manufacturing.
Extensive experience
- More than ten quality analyses CMC projects , and some projects have accomplished FDA and NMPA IND applications.
Professional team
- Experienced scientists and technical teams with 10+ years of analysis experience.
Advanced equipments
- Comprehensive and advanced analytical instruments, such as mass spectrometry, chromatography, capillary electrophoresis, spectroscopy, flow cytometry, fluorescence quantitative PCR, multi-mode microplate reader, etc.
Full-life analysis
- Provides pharmaceutical proteins testing services at all stages from drug discovery to drug development to manufacturing and release, including sample testing, method development, method validation, etc.
Stricte quality control system
- Provides analytical method development, validation and testing services in line with China, United States, European Pharmacopoeia and ICH guidelines, with a strict quality control system under full GMP guidance.
Complex or new-format samples
- Experienced in method development and detection services for complex structures or new-format samples.