Home » Biologics CDMO » ADC Bioconjugation CMC New!
  • Antibody CMC

    Antibody CMC

    • Fast timeline
    • Extensive experience in IND-enabling CMC projects involving mAb, bsAb, and antibody fragments
  • Bioconjugation Process Development

    Bioconjugation Process Development

    • 3 IND clearances from delivered conjugation CMC projects
    • Successfully delivered a CMC project of 4-step conjugation
  • AXC Project Experience

    AXC Project Experience

    • Ab conjugated to chelator (Intermediate for ARC)
    • Ab conjugated to oligo-nucleotide
    • Ab conjugated to protein
  • GenScript ProBio’s bioconjugation process development platform includes the process development of lysine-baed/cysteine based stochastic conjugation, site-specific conjugation based on THIOMAB and enzyme-assisted conjugation, etc..
  • Based on the QbD concept, GenScript ProBio conducts in-depth research on key parameters of conjugation process development, such as DAR control, removal of aggregates, removal of naked Ab/residual payload, etc. and address the various challenges encountered in the process development, ensuring the rapid advancement of ADC CMC projects.
  • In addition to ADC projects, GenScript ProBio also provides bioconjugation process development service for emerging new conjugation modalities, including but not limited to,
    • AOC(Antibody-Oligonucleotide Conjugate)
    • PDC(Peptide-Drug Conjugate)
    • ACC(Antibody-Chelator Conjugate)

The laboratories of ADC conjugation process development and formulation development are equipped with OEB-5 level isolators, which support the conjugation of multiple types of payloads.

  • The formulation study includes
  • Formulation study
  • Lyophilization screening and optimization
  • ADC DS and DP stability study: stressed, accelerated, and long-term stability
  • In-use compatibility and stability studies to support clinical dosing or toxicology studies
  • Lyophilizer

  • DSC

  • nanoDSF

  • DLS

GenScript ProBio established platform methods for structure confirmation, physiochemical properties, bioactivity, and impurity analysis of naked antibody and ADC. We will evaluate the impact of bioconjugation to antibody primary structure and its bioactivity, define the conjugation site(s), DAR values, and payload distribution, as well as conduct qualitative and quantitative evaluation for impurities (e.g., residual payload, residual solvents and heavy metals) introduced from bioconjugation process.

A variety of instruments and equipment and a dedicated cell engineering team are in place to support ADC method development and qualification, as well as extended characterization.

  • Conjugation site identification
  • Drug load distribution (HPLC, LC-MS)
  • Impurity (Free payload, Residual solvent, and Heavy metal elemental analysis)
  • Biological properties (Cell-based potency-cytotoxicity, Bystander effect, Payload MOA-based effect)
  • Single-use Conjugation Reactor

  • Chromatography System

  • OEB5 Isolator

  • Automatic Filling Machine

  • Lyophilizer

  • DS Production Capacity
    Capacity 0.5-1 kg/batch, 30 batches/year - 15-30 kg/year
    Key Equipment 50L~200 L single-use conjugation reactor,
    Single-use mixer and holder (50 L,100L, 200 L, 500L)
    AKTA chromatography system, UF/DF system
    OEB5 isolator
  • Fill and Finish Capacity
    Vial size 50ml 20ml
    Filling speed 70 vial/min 100 vial/min
    6 hrs forecasted output (liquid) 315L (12.5ml/via) 288L (8ml/vial)
    Lyophilizer capacity 3500 vials 7500 vials