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