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ADC的分析和表征

Analytical Development and Characterization of ADCs and other Bioconjugates

At WuXi XDC, we leverage in-house expertise and state-of-the-art analytical equipment to characterize the distinct intermediates (e.g., protein/mAb, payload and linker) and the bioconjugate or antibody drug conjugate (ADC) therapeutic candidates at various stages of development. Methods utilized to assess and characterize these complex bioconjugated molecules include UV/VIS, HPLC, cIEF, LC-MS and analytical assessment of drug-to-antibody ratio, free-drug content, ADC affinity, protein concentration, aggregation, PI, peptide mapping and potency tests.

Methods utilized to assess and characterize these complex bioconjugated molecules include (but are not limited too):

 

  • HPLC

 

    • Drug-to-Antibody Ratio
    • Conjugation Efficiency
    • Aggregation
    • Free Drug Residue

 

  • MALS

 

    • Aggregation
    • Nanoparticle Characterization

 

  • LC-MS

 

    • Drug-to-Antibody Ratio
    • Conjugation Efficiency
    • Free Drug Residue
    • Peptide Mapping

 

  • Plate Reader

 

    • Ligand Binding/Affinity
    • In vitro Potency Test

 

  • Capillary Electrophoresis (CE) and Capillary Isoelectric Focusing (CIEF)

 

    • Non-Reduced & Reduced (CE-SDS)
    • Determination of pI (cIEF or iCIEF)

 

  • UV/Vis (NanoDrop and SoloVPE®)

 

    • Protein Concentration
    • Drug-to-Antibody Ratio

 

Additional Bioconjugate Characterization Capabilities: 

  • Capillary Electrophoresis (Charge Heterogeneity and Product-related Impurities)
  • Native MS (Intact Molecular Weight Determination under Native Conditions)
  • Peptide Mapping (Conjugated Sites and Occupancy) 
  • Accurate Kd Determination

 


 

Formulation and Drug Product Development

 

We offer extensive end-to-end services for formulation/process development for a wide variety of bioconjugates. Our team assists from early-stage molecular assessments to development of First-in-Human (FIH) formulations to enable clinical trial starts. Additionally, we further provide commercial formulations lock and process/device development in preparation for product launches.

 

We are experts in developing liquid, frozen or lyophilized dosage forms filled into vials as well as special dosage forms for products containing nanoparticles and other advanced molecular complexes.

Our services include, but are not limited to:

  • Forced degradation studies to identify product degradation pathways
  • High-throughput screening (HTS) for formulation development utilizing biophysical methods
  • Design of Experiment (DOE) to identify the optimal formulations
  • Container and closure selection and integrity testing
  • End-to-end fill process development from drug substance thawing through mixing, filtration, filling, stoppering and capping to final visual inspection
  • Processes development for isolator-based filling systems
  • Pilot scale (non-GMP) fill finish and lyophilization services for pre-clinical toxicology studies, non-GMP stability studies and scale-down process development
  • Lyophilization cycle development and optimization
  • Fill finish and lyophilization process scale-up and/or technology transfer, from development to clinical phase or commercial manufacturing
  • In-use compatibility and stability studies to support clinical administration or toxicology studies
  • Stability studies to support formulation and process development under long-term, accelerated or stressed conditions

A partial list of key, cutting-edge equipment used in formulation development includes:

  • mDSC
  • DLS
  • Rheometer
  • Freeze-drying microscope
  • DSC
  • KF moisture analyzer
  • FTIR microscope
  • Automated screening station
  • High throughput buffer exchange
  • CG-MALS
  • Filling line
  • Lyophilizer
  • Freeze-thaw System
  • MFI
  • HIAC
  • Headspace analyzer
  • Silicone oil distribution analyzer