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Services & Solutions

One Stop Payload-Linker Services

WuXi XDC offers comprehensive and integrated discovery, CMC development, and cGMP manufacturing of ADC payload, ADC linker, and payload-linker chemical intermediates for Antibody-Drug Conjugates (ADCs) and broader conjugate therapeutics.

 

In addition to our well-established ADC service capabilities, we have been continuously expanding to new modalities, including peptide and oligonucleotide based bioconjugates, like to support a broader range of next-generation targeted therapies.

Why Partner with WuXi XDC

 

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

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 ADC payload, ADC linker and ADC payload-linker journey from R&D to commercialization. Our HP development capabilities include:

Development Capability

 

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

 

Analytical Development

 

  • UHPLC/HPLC (Agilent, Waters, Thermo, SHIMADZU)
  • GC, HS-GC (Agilent, SHIMADZU)
  • LC-MS, GC-MS, IC, SFC
  • DSC, TGA, XRPD, PSD, Polarized Light Microscope
  • ICP-OES and ICP-MS elements analysis, AAS atomic analysis
  • Kjeldahl Auto Analyzer for nitrogen and protein quantitation
  • KF, ROI, Potentiometric Titrator, Melting Point, DVS

 

Strong Enabling Technologies

 

  • Flow chemistry (hydrogenation, condensation, deprotection, etc.)
  • Bio/Chem-catalytical process screening and application
  • Solid-state chemistry study, crystalline process development

 

 

Payload-Linker Manufacturing

 

With a highly vetted, global regulatory agency-approved quality management system and cutting-edge equipment, we provide comprehensive services of payloads and linkers, including PC, PPQ, and commercial manufacturing.

  • Containment: Facilities designed for OEB-5 criteria enable safe handling of materials with OEL as low as 10 ng/m³.
  • Flexible Production Scales: Two manufacturing sites with many reactors from 10 L to 3,000 L, supporting programs from gram-scale to > 10 kg commercial-scale.
  • Isolation and Purification: Strong prep-HPLC and lyophilization capacity.
  • Analytical Development and QC: GMP-compliant method development and validation to conduct release and stability testing for large variety of payload-linker products.
  • Specialized Analytical Testing: An onsite suite including IR, HPLC, GC, KF, DSC, XRPD, and stability chambers down to -70°C with high-containment sample handling.

 

 

Selected Off-the-Shelf Payload Linker Library

 

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
42606
MMAE
42769
MMAE
42618
Payload-linker vcMMAE
42678
Payload-linker vcMMAE
40532
MC-GGFG-Exatecan
43548
MC_GGFG_Dxd
44127
Mertansine (DM1)
44126
DM1-SMCC
Non-GMP and
GMP Manufacturing
Available

*Patent expiration year

 

Containment Design of Payload-Linker Manufacturing Facilities

 

 

Separate personnel and materials flow

 

Three layers of engineering control

  • Suites access control
  • HVAC (safe-change system for HEPA installation and replacement）
  • Rigid isolators

 

PPE

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

 

Gowning room

  • Integrated gowning room for lab access
  • Positively pressurized (≥15 Pa) gowning buffer room
  • Gowning and de-gowning through the buffer room
  • Mist shower before 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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