“Technology and Capabilities in Discovery, Nonclinical and
TECHNOLOGY
R&D Discovery: Technology & Capabilities
Cell Biology
- Antibody target discovery and validation
- Construction of recombinant vectors and cell lines for antibody production
- MCB/WCB screening & GMP production management
- Process development for cultivation, purification and productivity enhancement
- Antibody dependent cytotoxicity assay (ADCC)
- Complement dependent cytotoxicity assay (CDC)
- Anti-proliferation assay
- Target specific cell based assays Fc/FcRn binding assays
Bioanalysis
- Process related impurity assay (ELISA, Threshold, Q-PCR)
- Chromatographic analysis: RP-HPLC, Ion exchange and size exclusion HPLC
- Gel electrophoresis: SDS-PAGE, CE-SDS
- Formulation analysis: HPLC, ELISA, LCMS/MS
- Pharmacokinetic and toxicokinetic analysis: ELISA, LCMS/MS
- Analytical method development and validation (GLP)
- Anti-drug antibody (ADA) assay
- Neutralizing antibody assay
- Biosimilar comparability analyses
- Antibody drug batch release test
Nonclinical Study
- Efficacy studies in relevant rodent models
- Pharmacokinetic studies
- Rodent/non-rodent toxicology and toxicokinetic studies
- Non-human primate toxicology and toxicokinetic studies
- Management of outsourced studies including protein characterization, viral clearance, and tissue-cross reactivity
Quality Assurance
- Maintaining OECD and US FDA GLP compliance for in-house and outsourced GLP studies
- Surveillance on GMP on CMO production, QP release