UPLC Waters
ANALYTICAL DEVELOPMENT AND QUALITY CONTROL
With an experienced professional team, ADQC department can provide analytical service from drug development to clinical trial in compliance with GLP and cGMP. The service covers analytical method development, verification, and validation for mAb and GCT related sample test, product characterization, stability study, and lot release. Also, related analytical data interpretation, report, and quality control section writing for IND filling can be provided.
Service Items
Physico-chemical method development and validation
Bioassay development and validaiton
Product characterization
Stability study
Biosafety test
Lot release
Titer
UV
ELISA measurement
HPLC affinity chromatography
Physico-chemical Analysis
HPLC/CE analysis for purity, aggregation, fragments, heterogeneity, Isoelectric point, etc.
Regular test for appearance, PH, osmotic pressure, etc.
Protein Characterization
Molecular weight, primary structure, post-translational modification, and glycosylation analysis by high resolution Mass Spectrometry
High order structure (CD, FLD)
Thermal stability analysis DSC
Bioassay
Bioactivity analysis based on cell/ELISA
Fc functional test
Phenotype analysis of immune cell
Cytotoxicity assay
Impurity Test
Host cell protein analysis
Residual DNA analysis
Residual RNA analysis
Biosafety Analysis
Rapid microbial culture and identification
Mycoplasma test (Q-PCR)
Endotoxin test
Sterility test
Platform
To provide our clients with high quality analysis and data, our analytical platform is equipped with up to date analytical instruments, such as High Resolution Mass Spectrometer, (U)HPLC, Capillary Electrophoresis, Real-time PCR, Flow Cytometer, etc.
+86 0512 88850385
BD.SZ@portonbio.com
Building 3, Ascendas Park, No.388 Xinping Street, Suzhou Industrial Park, Jiangsu 215021, China
