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One-Stop Antibody drug conjugates (ADCs) and
Bioconjugates Services

WuXi XDC

Your Single Source for Bioconjugation Discovery, Development and cGMP Manufacturing

WuXi XDC (stock code：2268.HK), a leading Contract Research, Development and Manufacturing Organization (CRDMO) focused on the global ADC and broader bioconjugate market, is a pioneering CRDMO offering integrated, end-to-end services. Services are provided from proximately located, state-of-the-art laboratories and manufacturing facilities, allowing for a significant reduction in development timelines and costs. Our over 1000 skilled employees work across a global network to deliver expert-driven, high-quality and right-first-time project execution for our customers. By offering a single-source, open-access platform with the most comprehensive capabilities and technologies, WuXi XDC enables our biopharmaceutical partners to speed the development of innovative therapies for the benefit of patients worldwide.  


Vision & Mission

Our Vision

“Linking innovation to health” by offering an open-access platform with the most comprehensive capabilities and technologies in the global ADC (antibody drug conjugate) and XDC (other novel bioconjugate) industry.

Our Vision

“Linking innovation to health” by offering an open-access platform with the most comprehensive capabilities and technologies in the global ADC (antibody drug conjugate) and XDC (other novel bioconjugate) industry.

>
500

Clients

worldwide

>
200

Ongoing, integrated

CMC development programs

>
100

Successful INDs filed

by our clients, enabled through

WuXi XDC services

>
30

Ongoing late-stage,

integrated (Phase II / III) programs

Comprehensive capabilities and Vast project experiences from ADC to XDC

  • ADC/BsADC
  • Antibody-Oligonucleotide Conjugate
  • Antibody-Chelator Conjugate
  • Degrader Antibody Conjugate
  • Immuno-Stimulant Antibody Conjugate
  • Antibody-Peptide Conjugate
  • Vaccine Conjugate
  • PEGylation-Based Conjugate
  • Protein-Protein Conjugate
  • Antibody-Glycan Conjugate
  • Antibody-Fluorophore Conjugate
  • Peptide-Oligo Conjugate

Explore Our Services

Integrated ADC and Bioconjugate

Discovery Services

 

As a trusted antibody drug conjugate CRO and CDMO, our ADC discovery services integrate all discovery functions within a unified single platform to deliver seamless workflows, expedited decision-making, fewer development bottlenecks, and lower costs and shorter timelines from initial concept through to candidate selection.

Novel Conjugation Technology

 

The most clinically validated conjugation sites, including those used by many blockbuster ADCs, are interchain cysteines. Using these sites as a foundation, WuXi XDC developed the novel WuXiDARx conjugation platform. WuXiDARx provides a highly flexible target drug antibody ratio (DAR), demonstrated homogeneity, compatibility with native IgG1 and many commonly used linker-payloads, and a simplified CMC process. This technology is valuable not only at the discovery stage to streamline ADC engineering and identify optimal DAR when screening antibody/linker-payload combos, but also at the CMC stage to accelerate CMC development, reduce development risks and eventual large-scale manufacturing costs.

Integrated ADC and Bioconjugate Development Services

As a trusted antibody drug conjugate CDMO, we have established industry-leading development know-how for a wide variety of ADCs and bioconjugates across all aspects of conjugation process development (PD), analytical development and formulation and drug product (DP) process development. By partnering with WuXi XDC and utilizing our single-source development expertise, state-of-the-art conjugation technologies and streamlined development processes we can help you advance your bioconjugate into the clinic and on to commercialization.

Bioconjugate

Process development

To support your CMC-stage development activities, our hignly-trained and experienced process development team provides a wide rage of process development, scale-up, and tech-transfer to GMP manufacturing services for antibody drug conjugates (ADCs) and other drug bioconjugates or diagnostic and imaging reagents.

Bioconjugate

Formulation and DP

Process development

Our expert formulation and drug product development team designs liquid, frozen or lyophilized dosage forms for a wide variety of bioconjugates as well as special dosage forms for products containing nanoparticles and other advanced molecular complexes.

Analytical

Development

Leveraging in-house expertise and state-of-the-art analytical equipment. our analytical. bioassay and biosafety laboratories support all development functions and characterize the distinct intermediates (e.g.. protein/mAb. payload and linker) and the bioconjugate throughout all preclinical and clinical development stages.

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.

All-in-One Manufacturing: mAb intermediate, Payload Linker, DS,DP

WuXi XDC offers extensive GMP manufacturing for all bioconjugate intermediates (e.g., payload, linker and antibody/proteins) as well as dedicated GMP manufacturing facilities for clinical and commercial supply of bioconjugate drug substance and drug product. All manufacturing operations are compliant with GMP regulations of the FDA, EMA, and NMPA, which help ensures high quality manufacturing for innovative bioconjugate products.


Integrated cGMP Manufacturing from mAb/protein intermediate to ADC/Bioconjugate Drug Substance at the same building

 

  • 500 L - 2,000 L cell culture from mAb production
  • 5 L - 2,000 conjugation production
  • Production up to OEB-5

 

cGMP Bioconjugate Drug Product Manufacturing

  • Accommodates 2R, 6R, 10R, 20R & 50R
  • Two separate fillings lines, 2x5m2& 2x20m2 lyo, 6M dose/year (10R), 15 M dose/year (2R)
  • Production up to OEB-5

 


Payload and Linker Manufacturing Capabilities Include:

 

  • GMP high potency (HP) lab and plant to produce chemical payloads in scales from gram to >10 kilogram scale
  • All common reactions including HP hydrogenation reactions and HP cryogenic reactions
  • Production of compounds to OEL limit of 10 ng/m3
  • Isolation/purification includes prep-HPLC / lyophilization

 

New capacity expansion in Singapore to participate in global dual-sourcing commercial manufacturing (expected to commence operation by 2026).

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