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Payload and Linker Manufacturing

WuXi XDC offers comprehensive and integrated discovery, CMC development and cGMP manufacturing

WuXi XDC offers comprehensive and integrated discovery, CMC development and cGMP manufacturing of the payload,
linkers and payload-linker chemical intermediates used in the production of Antibody Drug Conjugates (ADCs) and
other bioconjugates.  

 

Payload and Linker Manufacturing Capabilities Include:

 

  • GMP high potency (HP) lab and plant to produce chemical payloads in scales from gram to >10 kilo scale
  • All common reactions including HP hydrogenation reaction and HP cryogenic reaction
  • Compounds: OEL limit down to 10 ng/m3
  • Isolation/Purification includes prep-HPLC / lyophilization
  • Analytical method development and validation for release and stability 
  • HP products testing under GMP conditions including; HP sample handling for IR, HPLC, GC, KF, DSC, XRPD, ROI,
    DVS, PLM, and stability chambers down to -70oC if required

 

 

WuXi XDC Payload/Linker Manufacturing Site Containment Design 

 

  • Separate personnel and materials flow
  • Three layers of engineering control
  • Control access suites 
  • HVAC (safe-change system for HEPA  installation and replacement)
  • Rigid isolators
  • PPE
  •  

    • Head to toe gowning suites
    • Double gloves
    • N95 mask
    • Goggles

     

  • Gowning room
  •  

    • Entering the lab through gowning room
    • Positively pressurized (≥15 Pa) buffer gowning room
    • Gowning and de-gowning through the buffer room
    • Mist shower used for exit

 

In addition to payload/linker development and manufacturing, WuXi XDC also provides extensive integrated
discovery, CMC development and GMP manufacturing of mAb/proteins intermediates used in the
production of ADCs and other bioconjugates