• Experienced scientists and technical teams equipped with state-of-the-art technologies
  • Capability of end-to-end analytical method development, product release and characterization, including physical and chemical analysis, binding analysis and cell-based assays
  • Extensive analytical experience with monoclonal antibodies, bispecific antibodies, fusion proteins, vaccines, ADCs, Virus Like Particles and mRNA etc
  • Accompanying your biomolecule through the complete CMC development, manufacturing and quality control
Quality Control and Product Characterization of Biologics

Quality analysis and quality control process for CMC of large biomolecule manufacturing

Analytical method development

Quality standard definition

Intermediate product quality control

Release and stability testing

Product characterization

  Content Analysis
Release Physical characteristics Appearance, Color, Clarity, Visible particulates, Subvisible particles, pH, Extractable Volume, Osmolality
Identity Peptide Mapping, pI
Content and Potency Protein Concentration, Potency
Purity SEC, CE-SDS, Charge Variants, PAGE, WB
Impurity and safety Bacterial endotoxin, Sterility, Microbial limit, Residual of HCP, HCD, Protein A/L
Characterization Raw material and ingredients Identification by IR, HPLC-CAD, etc
Primary structure LC-MS (MW, N/C-Terminal, Coverage, PTM, -S-S-, Variant), Glycans, AAA, free-thiol
Higher-order structure DSF, IR, CD, Fluorescence
Binding and Efficacy SPR, Octet, ELISA, FCM, Epitope binning or mapping
Function Cell based assays, ADCC, CDC, Proliferation, apoptosis, phagocytosis etc.
Case Study

N-Glycan profiling, no matter how complex they are

Accurate analysis of post translational modifications (PTM)

System suitability analysis and relative activity analysis of products with different activities

Characterization of Charge Variants: The molecular weight and PTM of each peak were analyzed by preparative iCIEF. Fragments were then collected using FFE for affinity and cell viability experiments

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