Analytical Development and Testing
Analytical development and testing across the molecule’s life cycle. Method development, qualification and transfer for small molecules and biologics, supporting discovery characterization through to GMP release — with one team carrying the method knowledge across stages.
OVERVIEW
Our biologics analytical capability includes both analytical development and testing for non-GMP samples and QC testing and releases for GMP drug substances and drug product. Our rapidly growing Analytical Development & Quality Control team comprises 40+ scientists (>60% with Ph.D. or M.S.) with a 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 the 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
