HPAPI Expertise: Handling, Synthesis & Purification of Highly Potent Active Pharmaceutical Ingredients

Highly effective services for highly potent molecules

Synthesis and Purification of Highly Potent APIs  

Novasep is a skillful developer of chemical routes yielding highly potent active pharmaceutical ingredients, such as cytotoxics.  The manufacture of highly potent APIs requires high containment manufacturing units as well as a high level of know-how. With our dedicated site in Le Mans - France, we have a twenty-year track record of success in the synthesis of highly potent molecules as well as purification by preparative chromatography and are world leaders in the synthesis and purification oftaxanes.

Our Offering for your HPAPI

Our expertise in HPAPI and cytotoxic compounds covers process development, scale-up and production.

We offer synthesis, semi-synthesis, purification by chromatography and vectorization of HPAPIs, from preclinical batches to commercial production which can be performed in a non-cGMP or cGMP and FDA inspected environment. We also provide full regulatory support, including the filing of DMFs (Drug Master Files).

We can combine our HPAPI expertise with any other one of our key technologies for synthetic molecules. Moreover, the combination of synthesis with industrial chromatography expertise in the field of HPAPIs makes our offering unique.

Because  we can also manufacture monoclonal antibodies,  proteins,  and purify peptides, we are one of the sole companies worldwide able to provide total manufacturing of vectorized highly potent APIs  such as antibody-drug conjugates (ADC) or peptide-drug conjugates preparation.

High containment facilities for HPAPI development and production

In order to safely handle highly potent molecules, we are equipped with 12 benches,  2 kilo-labs and 3 industrial suites as well as preparative chromatography systems fully dedicated to HPAPIs. Our production suites offer precise monitoring of operating conditions for optimal quality and productivity.

SafeBridge® certification and security of supply

Our Le Mans site is SafeBridge® certifiedmeaning that compounds with an Occupational Exposure Limit (OEL) less than 10 µg/m³/8h (SafeBridge® category 3) and < 0.03 µg/m³/8h (SafeBridge® category 4)  can be handled.

Protective measures:

• Collective protection: dedicated laboratories, glove boxes, highly efficient particle air filters, negative air pressure zones…
• Personal protective equipment: choice of PPE according to areas/product banding
• Standard operating procedures for handling HPAPIs
• Continuous training
• Occupational hygiene monitoring
• Medical surveillance of employees

Appropriate cleaning protocols prevent cross-contamination and guarantee your API’s purity. We challenge all our processes to continuously provide the highest protection for your products, our personnel and the environment.

A One-Stop Partner for Antibody-Drug Conjugate (ADC) Development and Manufacturing

Novasep is one of the sole CMOs in the world able to provide the complete manufacturing solution for ADCs, from early development to commercial scale. MAb production is managed at Novasep’s Seneffe site in Belgium, specialized in mammalian cell culture, whereas the toxin synthesis, the mAb-toxin conjugation and final purification is performed at Novasep’s Le Mans site in France.

Download our brochures for synthetic molecule manufacturing.

Contact us  for any synthetic molecule manufacturing request.