HPAPI manufacturing: from process development to cGMP production

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

• Novasep’s own 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:

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

• In-house 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!

Do you want to learn more about HPAPIs? Check out our FAQ!