Biologics CMC Analytical Development and Testing

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ChemPartner’s analytical capability includes analytical development testing for non-GMP samples, GMP drug substances, and drug product release and stability testing as well as extended product characterization. 

Our rapidly growing analytical development and quality control team is comprised of 50+ scientists (60%+ with PhD or MS degrees) with the combined experience of 100+ years in analytical development and 70+ years in cGMP. 

We offer a broad range of analytical services using state-of-the-art analytical instruments for our clients in preclinical and clinical development as well as commercial production. We are capable of developing all types of analytical methods for therapeutic proteins, including, but not limited to, monoclonal antibodies, recombinant proteins, antibody drug conjugates, and peptides for testing their general quality, identity, purity, impurity, potency, and microbiological testing. Our analytical team also supports regulatory submissions (IND or NDA) by providing the required product physicochemical characterization, analytical comparability studies, technical writing, and documentation.


Major analytical capabilities include:

  • Characterization & physicochemical analysis
    • Molecular weight 
    • Amino acid sequence
    • PTM (deamidation, oxidation, others) 
    • Disulfide bond 
    • Free Sulfhydryl group
    • Sialic acid   
    • N/C terminal heterogeneity 
    • N-terminal sequencing
    • N-glycan, O-glycan site and occupancy 
    • Secondary structure 
    • Tertiary structure 
    • Charge  
    • Size  
    • Aggregation 
    • Thermal & Colloid stability
    • Binding affinity 


Product release testing includes:

  • General Quality
    • Appearance
    • pH 
    • Protein Content
    • Weight Variation
    • Visible and Sub-visible particles
    • Moisture Determination
    • Osmolality
    • Excipients 
  • Physicochemical Property
    • Charge heterogeneity/pI 
    • Monomer/aggregates/fragments
    • Molecular weight/size heterogeneity
    • N-glycan analysis
    • Sialic acid analysis
    • Peptide mapping
  • Microbial Analysis
    • Endotoxin
    • Sterility
    • Bioburden                                    
  • Activity & Potency Analysis 
    • ELISA
    • ADCC/CDC/FACS
    • Reporter gene assays
    • Other cell-based assays            
  • Process Impurity  
    • HCP 
    • Leached Protein A 
    • Host cell DNA
    • Other process impurities

Headquarters

1F & 3F, Block A
2829 JinKe Road
Zhangjiang Hi-Tech Park
PuDong New Area
Shanghai China, 201203

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Contact Us

China: +86 21 5132 0088
US: +1 650 419 9974
Europe: +45 4586 9000
Japan: +81 03 5403 6975

contact@chempartner.com