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

  "Creating Differences and Value for Human Health"

R&D Discovery: Technology & Capabilities      

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

Prestige BioPharma

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