WuXi XDC
Single-Source CRDMO Services for ADCs/Bioconjugates
With complex molecules, bioconjugates often come with challenges across entire development journey. WuXi XDC offers an unprecedented single-source approach for ADC/bioconjugate discovery, development and manufacturing, covering antibody intermediates and other biologics intermediates, chemical payloads and linkers, as well as bioconjugate drug substances and drug products. This comprehensive one-stop approach provides more efficiency, flexibility, lowered risks, fewer transactional costs, and industry-leading timelines. Partner with WuXi XDC, advance your bioconjugate journey to commercial success!
Clients
worldwide
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
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
Bioconjugate
Process development
Bioconjugate
Formulation and DP
Process development
Analytical
Development
Bioconjugate Development Service
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.
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.
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
