Quality Control

Establishing Specification for Early Stage Development

Quantity and Potency

Strength (UV280, HPLC)

Protein purity (SEC-HPLC, RP-HPLC, CE-SDS)

Potency (Affinity, MOA related Cell-based assay , CDC, ADCC, Fc Receptor Function)

Establishing Specification for Clinical Use

Physiochemical

Appearance

General test: pH, osmolality, key excipients, particle

Identity : charge profile (CZE, IEC, cIEF) , peptide mapping, pI (IEF, cIEF)

Establishing Specification for Market Application

Structure

Intact mass (SDS-PAGE, CE-SDS, SEC-HPLC, DLS, LC-MS)

Peptide mapping and PTM (LC-MS/MS)

Glyco-profiling (HILIC-HPLC, CE-LIF, Chip-CE, LC-MS/MS)

Disulfide and free cysteins (LC-MS/MS, Ellman’s Assay)

Higher structure (CD,DSC, DLS , fluorescence)

Routine Use and Maintenance of Approved Specification

Impurities/Contaminants

Aggregate/product variants (SEC-HPLC, IEC, cIEF, HIC, RPLC)

HCP (ELISA)

Protein A (ELISA)

DNA (Q-PCR)

Endotoxin & bioburden

Sterility

Core competencies:

Complete analytical capabilities throughout the product life-cycle;

Analytical method development, transfer and validation ability complying to ICH/USP/EP/CP Guideline;

Strict quality control system covering IPC, Lot release and stability program;

Thorough comparability and quality research ability;

Validated LIMS system to assure data integrity and traceability.