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HPAPI manufacturing- from process development to cGMP production

HPAPI manufacturing- from process development to cGMP production

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 , 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  with a broad experience on different conjugation platforms & payloads types.
  • The , 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.

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 inHPAPIssynthesisand purification

An outstanding quality assurance track record

  • Facility inspected by the FDA, the ANSM (France) and PMDA (Japan) accredited
  • Download our brochure about  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  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  (Maytansines (DMx), Auristatins, , Camptothecins (CPT), etc.)

Strength of process development

  • Increased process robustness & accelerated timelines thanks to DoE (Design of Experiments)

Adapting and collaborative approach

  • , 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

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