ADC manufacturing
![ADC manufacturing at Axplora](https://ewec85ye45b.exactdn.com/uploads/2023/03/30140554/Axplora-ADC-manufacturing-1.jpg?strip=all&lossy=1&webp=80&ssl=1)
Antibody Drug Conjugates (ADCs) are one of the fastest-growing therapeutic classes in oncology with more than 120 ADCs in active clinical development and around 200 companies actively developing ADCs.
ADCs are complex molecules composed of:
- An antibody: a whole monoclonal antibody (mAb) or an antibody fragment such as a single-chain variable fragment
- A stable chemical linker with labile bonds
- An active cytotoxic payload
![ADC - Antibody-drug-conjugate](https://ewec85ye45b.exactdn.com/uploads/2023/03/15161250/ADC-Antibody-Drug-Conjugate.png?strip=all&lossy=1&webp=80&resize=188%2C167&ssl=1)
By combining the unique targeting capabilities of monoclonal antibodies with the cancer-killing ability of cytotoxic drugs, antibody-drug conjugates allow sensitive discrimination between healthy and diseased tissue.
Therefore, the manufacturing of ADCs requires biological and chemical know-how, as well as expertise in handling highly toxic compounds, which Axplora has mastered for many years.
Our expertise in ADC manufacturing
Axplora is respected as a key contract service provider in the ADC arena with more than 15 years of experience. We provide unique services for the development, fast-track, clinical supply, and commercial cGMP manufacture of ADCs including the payload linker and the bioconjugation.
By working with us on the development and manufacturing of your ADCs, you benefit from:
- Phase-adapted, scientifically sound development throughout your ADC drug lifecycle
- Multi-scale bioconjugation manufacturing capacity with short-term availability
- Fast-track bioconjugation services with seamless transition to clinical supply
- One-stop-shop for Drug Substance and Drug Product analytical services
- A 15-year clinical & commercial track-record – 200+ cGMP batches
- A cross-functional and collaborative approach between ADC experts
- Robust processes & analytics for complex molecules
- An excellent regulatory history
![ADC manufacturing expertise at Axplora](https://ewec85ye45b.exactdn.com/uploads/2023/03/30144839/Axplora-ADC-manufacturing-expertise-1024x476.png?strip=all&lossy=1&webp=80&ssl=1)
![Axplora ADC manufacturing](https://ewec85ye45b.exactdn.com/uploads/2023/03/15161559/Axplora-ADC-manufacturing.jpg?strip=all&lossy=1&webp=80&resize=600%2C400&ssl=1)
ADC manufacturing solutions
Axplora offers a full and flexible range of development, analytical, and manufacturing services for ADCs, whatever the stage of your project:
- Fast track offer for preclinical studies – One ADC sample with RoA
- 1 – 100 mg ADC sample
- Platform analytical methods
- 6 weeks turnaround time
- Phase I-II package – First in human clinical trials
- Process & analytical development
- Phase-adapted validation
- cGMP manufacturing
- Methods validation
- Phase III package – Support to validation
- Process characterization
- ICH analytical validation
- Process validation
- BLA regulatory support
- Commercial package – Lifecycle support
- Continuous improvement
- Product lifecycle management
Our dedicated team can tailor a custom manufacturing package. We will work with you to create a scope of work to complete the project on time and within your specifications.
![Axplora ADC manufacturing](https://ewec85ye45b.exactdn.com/uploads/2023/09/DP5R2883_%40DavidPiole-1024x683.jpg?strip=all&lossy=1&webp=80&resize=600%2C400&ssl=1)
ADC manufacturing capabilities
To learn more about Axplora’s ADC capabilities, download our brochure.
![Brochure CDMO services for ADCs cover](https://ewec85ye45b.exactdn.com/uploads/2023/09/CDMO-services-for-ADCs-cover.jpg?strip=all&lossy=1&webp=80&resize=205%2C290&ssl=1)
Center of excellence for ADC manufacturing
Axplora’s Le Mans site, located in France, specializes in ADCs. It offers a long track record in ADC production for payload synthesis & purification and bioconjugation. The site has been successfully inspected by the FDA and the European authorities recently.
![Axplora Le Mans center of excellence for ADCs](https://ewec85ye45b.exactdn.com/uploads/2023/03/15163435/Axplora-center-of-excellence-for-ADCs-in-Le-Mans.png?strip=all&lossy=1&webp=80&resize=945%2C343&ssl=1)
Axplora’s ongoing investment in the Le Mans site demonstrates our commitment to ADCs:
- 30M€ invested over the last ten years
- Pharmaceutical Establishment licensed for the release testing of ADC drug products
![Axplora ADC quality control](https://ewec85ye45b.exactdn.com/uploads/2023/03/15164058/Axplora-ADC-quality-control-1-1024x683.jpg?strip=all&lossy=1&webp=80&resize=600%2C400&ssl=1)