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Services & Solutions

One Stop Payload-Linker Services

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.

 

In addition to its established ADC capabilities, WuXi XDC is strategically expanding into new modalities, including peptide and oligonucleotide based bioconjugates, to support a broader range of next-generation targeted therapies.

Why Partner with Us

 

One-Stop Platform

An all-in-one platform integrates mAbs, payload-linkers, ADC DSs, and DPs from discovery to commercial manufacturing.

CMC Speed

The industry’s leading payload-linker CMC service timeline features < 9 months to IND and < 16 months for late-phase development.

Extensive Expertise

Our payload-linker specialists average over a decade of focused experience, delivering rapid development through deep technical insight.

Innovative Payload-Linker Technologies

Novel payload and linker platforms deliver advanced payload-linker solutions engineered for optimal safety, efficacy, and flexibility at every stage of development.
 

 

From ADC to XDC: Expertise in New Modalities

 

Singe-source accelerate molecule modification, route design, synthesis, and GMP production for chelators and chelator-linkers. Example chelators include NOTAM, NOTA, and DOTA.

Examples of various chelators offered by WuXi XDC: NOTAM; NOTA; DOTA; TETA; HBED; DTPA

Through our partner WuXi STA, R&D-scale oligonucleotide synthesis and larger-scale non-GMP/GMP manufacturing along with full process and analytical development and QC. Screening of oligo-antibody conjugate combinations is also available for AOC developers.

Liquid/solid phase peptide synthesis, along with full analytical method development and non-GMP & GMP manufacturing is available for the CMC development and production of peptide drug conjugates.

 

 

High Potency Chemical Development and Manufacturing

 

With extensive development experience for various high potency chemical entities, we accelerate your payload/payload-linker journey from R&D to commercialization. Our HP development capabilities include:

Development Capability

 

  • Process development for >kg scale batch size
  • Custom synthesis, FTE, or FFS

 

Analytical Development

 

  • UHPLC/HPLC (Agilent, Waters, Thermo, SHIMADZU)
  • GC, HSGC (Agilent, SHIMADZU)
  • LC-MS, GC-MS, IC, SFC
  • DSC, TGA, XRPD, PSD, Polarized Light Microscope
  • ICP-OES, ICP-MS, AAS, Kjeldahl Auto Analyzer
  • NMR, Q-Tof MS, FT-IR, UV-Vis, Polarimeter, Raman Spectrometer
  • KF, ROI, Potentiometric Titrator, Melting Point, DVS

 

Strong Enabling Technologies

 

  • Hydrogenation
  • Flow chemistry
  • Bio-catalysis
  • Chem-catalysis
  • Solid-state chemistry

 

 

Manufacturing High-Potency Payload-Linkers

 

With a highly vetted, global regulatory agency-approved quality management system and cutting-edge equipment, we provide comprehensive GMP manufacturing for high-potency payloads and linkers.

  • Containment: Facilities designed for OEB-5 compounds enable safe handling of materials with OEL down to 10 ng/m³.
  • Flexible Production Scales: Two manufacturing sites with reactors from 10 to 3,000 L support programs from gram-scale through > 10 kg commercial-scale.
  • Isolation and Purification: Facilities are equipped with preparative HPLC and lyophilization capabilities.
  • Analytical Development and QC: GMP-compliant method development and validation to conduct release and stability testing for high-potency products.
  • Specialized Analytical Testing: An onsite suite includes IR, HPLC, GC, KF, DSC, XRPD, and stability chambers down to -70°C with high-containment sample handling.

 

 

Selected Off-the-Shelf Payload-Linkers

 

Linker
  • Val-Cit-based
  • Val-Ala-based-PnP/PFP
  • PEG-based
  • GGFG-based
  • SMCC
  • Hydrazone-based
  • Glutathione
  • Long-chain amino acid-based
  • Sugar-based
Payload
  • MMAE
  • MMAF
  • Exatecan
  • DM1
  • DM4
  • SN38
  • PNU
  • PBD
  • Eribulin
  • PBD dimers (2033*)
  • Calicheamicin
Payload-Linker
  • MC-VC-PAB-MMAE
  • M-PEG-VCP-eribulin
  • MC-GGFG-exatecan
  • MC-MMAF
  • SMCC-DM1
  • MC-PEG-VC-exatecan
  • Tesirine (2033*)
  • CL2A-SN38
  • GGFG-DXd (2033*)
  • SPDB-DM4
Registered DMF
37610
Exatecan Mesylate
38725
MC-VC-PAB-MMAE (commercial)
42618/42768
MC-VC-PAB-MMAE (clinical)
42606/42769
MMAE (clinical)
36725
MC-MMAF
040532
MC-GGFG-Exatecan
Non-GMP and
GMP Manufacturing
Available

 

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.

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