Telephone sharing button Contact Us linkedin sharing button Share wechat sharing button Share wechat sharing button Twitter mailbox sharing button info@wuxibiologics.com
arrow_left sharing button
arrow_right sharing button

Payload and Linker 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