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

nonclinical
  • 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

quality-assurance
  • Maintaining OECD and US FDA GLP compliance for in-house and outsourced GLP studies
  • Surveillance on GMP on CMO production, QP release