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Service
Content
Service Content
A comprehensive QC quality control system, with quality studies running through the entire R&D and manufacturing process of biomolecular drugs. Services include development and establishment of analytical methods, characterization of physicochemical properties and biological activity, as well as evaluation and control of microorganisms and residual impurities.
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| Item | Test Parameter | Method | Deliverable & Specification |
| Identification | pI | iCIEF, rSDS-PAGE | Test Report |
| Peptide Mapping | RP-HPLC | Test Report | |
| Assay | Protein Concentration | UV, HPLC | Test Report |
| Excipient Content | RP-HPLC | Test Report | |
| Purity | Size Variants | CE-SDS, SDS-PAGE, SEC, CEX, etc. | Test Report |
| Impurities | Charge Variants | iCIEF, IEC | Test Report |
| RP-HPLC Related Impurities | RP-HPLC | Test Report | |
| Host Cell DNA (HCD) | qPCR | Test Report | |
| HCP | ELISA | Test Report | |
| Protein A | ELISA | Test Report | |
| Bioactivity | Binding Activity, In-vitro Bioactivity | ELISA / Cell-based Assay | Test Report |
| Microbiology | Endotoxin, Bioburden, Sterility | Test Report | |
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Equipment
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Equipment Showcase
QC laboratory is equipped with a full portfolio of testing instruments including microplate readers, capillary electrophoresis systems (PA800, MAURICE), HPLC, LC-MS, UV spectrophotometers, IR spectrometers, qPCR instruments, aseptic isolators and walk-in incubation chambers, to support testing demands for diverse biotherapeutics across all development stages.
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UPLC+MS -
Aseptic Testing Isolator -
Maurice Capillary Electrophoresis System -
PA800 Capillary Electrophoresis System -
High Performance Liquid Chromatograph (HPLC) -
LC Laboratory -
Stability Laboratory -
QC理化检验室