Demand for Highly Potent Active Pharmaceutical Ingredients (HPAPIs) is growing strongly, driven by the need for targeted medicines in the oncology field. Due to their high pharmacological activity, the development and manufacturing of HPAPIs requires high containment facilities operated by experienced personnel. By nature, HPAPIs are often complex molecules & need specialized technologies for multi-step synthesis and purification.
Novasep offers a full range of CDMO services for HPAPIs, with 2 sites experienced in high potency manufacturing:
- The Le Mans site, located in France, is a facility dedicated to the development & manufacture of HPAPIs & cytotoxics. The site is equipped to handle compounds with an OEL below 30 ng/m³/8hrs and a maximum batch size of 10 kgs. The site provides a full and flexible range of ADC manufacturing services with a broad experience on different conjugation platforms & payloads types.
- The Chasse-sur-Rhône site, located in France, is a flexible facility offering a full range of CDMO services for APIs and intermediates. The site is equipped to handle Potent APIs with an OEL to 1 μg/m³/8hrs and a maximum batch size of 350 kgs.
Discover a summary of Novasep’s capabilities by site:
A recognized expertise in HPAPI manufacturing
Novasep’s Le Mans site has a proven track record in the development and commercial production of Highly Potent APIs.

Strong experience in high potency manufacturing
- The Le Mans manufacturing site benefits from more than 30 years of experience in HPAPIs synthesis and purification
An outstanding quality assurance track record
- Facility inspected by the FDA, the ANSM (France) and PMDA (Japan) accredited
- Download our brochure about CDMO services for APIs to learn more!
Depth of EHS culture & know-how
- The Le Mans site is capable of handling both OEB Band 3 & Band 4 compounds (Safebridge) including cytotoxics. In the case of ADC payloads, Novasep is manufacturing HPAPIs with an OEL below 30 ng/m³/8hrs
Recognized expertise in industrial chromatography
- High-performance automated HPLC equipment
- Proprietary methodology and modeling for optimized scale-up
- Check out our preparative chromatography services webpage to learn more!
Leading supplier of ADC payloads
- With more than 10 years of experience, Novasep is today a commercial supplier, with a demonstrated track record of success in the synthesis and the purification of ADC payloads (Maytansines (DMx), Auristatins, PBDs, Camptothecins (CPT), etc.)
Download our ADC payloads case study to learn more!
Strength of process development
- Increased process robustness & accelerated timelines thanks to DoE (Design of Experiments)
Adapting and collaborative approach
- Experienced Project Managers, always reactive to changes in customer needs, ensuring regular communication & keeping our projects on track
Flexible production capabilities under cGMP
- Workshops equipped with flexible synthesis and purification equipment
- New facilities for commercial production
To learn more about our HPAPI manufacturing expertise, check out our leaflet including a case study & watch our webinar recording:
Type of content |
Title |
Case study |
Successful process development and manufacturing of an ADC payload from phase I to commercial |
Webinar recording |
Safe HPAPI manufacturing: Thinking outside the glovebox! |
Article |
Safe HPAPI manufacturing: Thinking outside the glovebox! |
Novasep Le Mans site also offers CDMO services for ADC bioconjugation:
Download our ADC manufacturing brochure to learn more!
A full range of CDMO services for Potent APIs
Novasep’s Chasse-sur-Rhône site has a proven track record in the development and commercial production of Potent APIs.
Strong background in scale up, validation & commercial production
- 50 years of experience in API synthesis & purification
- 7 successful process validations for APIs since 2018
- Outstanding regulatory track record
- Close partnership with Novasep Le Mans site to supply upstream intermediates for HPAPIs
Expertise in oncology
- Novasep has a strong experience in the scale up, validation & commercial production of APIs for oncology such as kinase inhibitors & other therapeutic areas.
Quality management system in compliance with ICH Q7 requirements
- Key procedures harmonized between sites
- QA system evaluated periodically through Novasep audits and customer audits
Specialized technologies
- HPLC chromatography
- Cryogenic chemistry & Ozonolysis
- Broad toolbox of classical technologies including hydrogenation, metal catalyzed couplings & halogenation
EHS culture
- Mastering all aspects of EHS to ensure the safe handling of Potent APIs

Project Management support
- From initial assessment & planning to final delivery & close-out
- Dedicated Project Manager
Download our Potent APIs leaflet to learn more about Novasep’s Potent APIs capabilities!
Our solutions for high potency manufacturing
Novasep offers a full range of high potency manufacturing services, from process development to cGMP production:
Process development
- Transfer and continuous improvement of established processes
- Development & scale-up of new processes
- Development, optimization and validation of analytical methods
- Safety assessments
Kilolabs
- cGMP production for clinical trials
- Process validation
- Commercial supply
Large-scale production
- cGMP production for clinical trials
- Process validation
- Commercial supply
Quality control
- Method development / transfer / validation
- IPC
- Release testing
- ICH Stability studies
- Regulatory support
To learn more about Novasep’s Highly Potent APIs capabilities, download our dedicated leaflet!
Do you want to learn more about HPAPIs? Check out our FAQ!