ADC payload manufacturing
ADC payloads are usually complex structures produced through a 10-20 step synthesis process or by hemi synthesis. Manufacturing HPAPI’s such as ADC payloads requires a contained and specially designed environment along the development and manufacturing process including R&D, analytical, production and storage.
With more than 15 years of experience, Axplora is a world-leading commercial supplier of ADC payloads with a demonstrated track record of success in the synthesis and purification of the main classes of payloads.
A world leader in ADC payloads manufacturing
Axplora is recognized as a leader in the development and commercial production of ADC payloads with a successful track record of over 200 clinical and commercial cGMP batches produced.
- Track record in the main classes of ADC payloads
- Auristatins
- Maytansines (DMx)
- Pyrrolobenzodiazepines (PBD dimers)
- Tecans
- Customer proprietary payloads
- High purity
- Expertise in HPLC chromatography
- Complex molecules purification
- Safe handling of compounds with very low OEL
- Equipped to handle highly potent compounds with OEL below 30 ng/m3/8hrs for R&D, small- & large-scale manufacturing, and QC
- Agile cGMP manufacturing
- 30 g to >1 kg per batch
- Pro-active & robust scale-up strategy to secure your supply chain in a cost-effective manner
To learn more about our expertise in ADC payloads manufacturing, discover our content:
| Type of content | Title |
| Leaflet including a case study | Successful process development and manufacturing of an ADC payload from Phase I to Commercial |
Our ADC payloads manufacturing solutions
Axplora offers a full range of ADC payloads manufacturing services, from process development to cGMP production:
- Development
- Process & analytical transfer
- Process & analytical development
- Process characterization
- Demonstration batch at 10-20g
- Medium scale manufacturing
- cGMP production for clinical trials
- Process validation
- cGMP production for commercial supply
- Batch size: up to 500g
- Large-scale manufacturing
- cGMP production for clinical trials
- Process validation
- cGMP for commercial supply
- Batch size: kilogram-scale
- Quality Control
- Method development, transfer, and validation
- IPC
- Release testing
- Stability studies
Our center of excellence for ADC payloads manufacturing
Located an hour from Paris by high-speed train, the Le Mans manufacturing site has over thirty years of experience in HPAPIs manufacturing and industrial chromatography. It has been successfully inspected by the European authorities and the FDA recently.
In addition to ADC payloads manufacturing, the site also offers bioconjugation services for ADCs to ensure chain simplification, timeline and cost optimization, and risk reduction.
This center of excellence for ADCs also allows a cross-functional collaborative approach between ADC experts and smoother project management with one global contract and quality agreement.
Our latest investments for ADCs
Our ongoing investment in the Le Mans site demonstrates our commitment to ADCs:
- +23M€ invested over the last 10 years
Discover why Axplora is a first-choice CDMO partner for your ADC development and manufacturing:
