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“Technology and Capabilities in Discovery, Nonclinical and
Clinical Development of New Biologics and Biosimilars”
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