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Payload and Linker R&D and GMP Manufacturing

WuXi XDC offers comprehensive and integrated discovery, CMC development and cGMP manufacturing for chemical payloads and linkers

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.  

 

WuXi XDC payload-linker R&D and GMP manufacturing is located in the newly developed area north of Changzhou in the Jiangsu Province of China, approximately 180 km from Shanghai.  Beyond the extensive experience in the discovery, development, analysis and production of small molecules and payload chemical entities, the site also has strong capabilities in technologies such as catalytic hydrogenation, fluid dynamic chemistry, and biocatalysis making it a unique single-source for chemical payload-linker development and synthesis.

 

With a highly-vetted, and global regulatory agency approved, quality management system and cutting-edge equipment, this site is able to handle OEB-5 materials (OEL~10 ng/m3) ranging from several milligrams to tens of kilograms.  The quality systems at this site satisfy the quality and cGMP standards outlined by the U.S. FDA, EMA and NMPA.

 

Other Site Capabilities:

  • Process and analytical development
  • Pilot synthesis
  • Capable of a wide variety of chemical reactions including hydrogenation of highly potent compounds and low-temperature reactions
  • Able to conduct sensitive reactions such as low-temperature and light-sensitive reactions
  • HPLC purification and lyophilization under GMP conditions
  • Development and qualification of analytical methods; release tests and stability studies
  • High-potency lab and plant with the ability to test highly-potent compounds (including -70C stability studies) using IR, HPLC, GC, KF, DSC, XRPD, ROI, DVS, PLM

 

In addition, WuXi XDC provides ready-made (“off-the-shelf”) chemical payloads and linker intermediates many maintaining DMF information and data residing with global regulatory agencies, and thus these molecules are ready for IND filing. Our Library of ready-made compounds (available GMP and non-GMP) include:

 

  • Common ADC payloads: VC-MMAE, MC-MMAF, MMAE, MMAF, SN38, Exatecan Mesylate, DM1, DM4, PNU, PBD, Teserine
  • Common ADC linkers: MC-VC-PAB-PNP, Glu-VC-PAB, NHS-Glu-VC-PAB, Azido-Glu-VC-PAB, Hydrazone (acid Sensitive), Disulfide (Glutathione sensitive), SMCC

(Note: Bolded items are those molecules we maintain Drug Master Files (DMFs) with various global regulatory agencies)

 

 

Payload and Linker Manufacturing Capabilities:

  • 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