Analytical Development and Testing
Our analytical capability includes both analytical development and testing for non-GMP samples and QC testing and release for GMP drug substance and drug product. Our rapidly growing Analytical Development & Quality Control team comprises 40+ scientists (>60% with Ph.D. or M.S.) with combined experience of over 100 years in analytical development and over 70 years in the cGMP respectively. We apply the latest instrument to conduct a broad scope of analytical services for our clients from preclinical development, clinical trial, and commercial production. We are capable of developing most of analytical methods for therapeutic proteins, including but not limited to monoclonal antibodies, recombinant proteins, antibody drug conjugates, fusion proteins, and peptides. Our analytical team also supports regulatory submissions, such as IND or NDA, by providing required analytical method validation, testing and documentation.
Major analytical capability includes:
Characterization
- LC-MS/MS (Thermo QE plus EMR, QE, Sciex 5600); CD (Jasco)
- Sequence, PTM, Disulfide bond, Primary/Secondary structure
Biophysical Analysis
- iCIEF (Maurice C); CE-SDS; SEC-SLS; CEX; DSC; DLS
- PI, Aggregation, Degradation, Thermal & Colloid stability
Activity
- Biacore (8K, T200, X100), Octet, FACS
- Binding & Cell-based Activity