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

419

Clients

worldwide

167

Ongoing, integrated

CMC development programs

Successful INDs filed

by our clients, enabled through

WuXi XDC services

Ongoing late-stage,

integrated (Phase II / III) programs

As of end 2023

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

Bioconjugation

Discovery Services

With a comprehensive ADC/Bioconjugation discovery toolbox and world-class expertise, we offer integrated discovery services from target identification to pre-clinical lead candidate selection. Our wide-ranging discovery capabilities for ADC/Bioconjugation also include key intermediates such as mAb/protein and payload linkers.

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.

Our Comprehensive,single-Source Bioconjugate Development Service Platforms

At WuXi XDC, we have established industry-leading development know-how for a wide variety of 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 the payloads, linkers and payload-linker chemical intermediates used in the production of Antibody Drug Conjugates (ADCs) and other bioconjugates.

With a highly-vetted, and global regulatory agency approved, quality management system and cutting-edge equipment, we safely handle OEB-5 materials (OEL~10 ng/m3) ranging from several milligrams to tens of kilograms. Our production capabilities include 10L - 3,000L reactors and 10 square meter lyophilizer to handle the market’s increasing commercial manufacturing needs.

Besides, we also offers a growing library of common payloads and linkers for use in a variety of R&D and pharmaceutical purposes including use as chemical intermediates in the production of ADCs and other bioconjugates. These ready-made small molecule entities can be manufactured as both GMP and non-GMP grade, and we provide DMF files for common payload-linkers to expedite the path from CMC development to IND.

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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).