TRUST A RELIABLE, LONG TERM PARTNER TO SUPPORT THE PRODUCTION OF YOUR HIGHLY POTENT API
25 years of experience in HPAPIs synthesis and industrial chromatography
bringing you robust processes for cost-effective manufacturing of cytotoxics
Based in Le Mans, France, Novasep’s center of excellence for highly potent API’s is dedicated to support our clients through the development and implementation of manufacturing processes for HPAPI’s.
Novasep offers a full range of CMO services from the first grams to clinical supplies to full commercial scale:
- including technical transfer, process optimization, demonstration to full validation.
- a detailed risk evaluation is an integral part of our EHS approach.
- regulatory support
- continuous improvement approach
In some cases our customers may prefer a dedicated production workshop within our facilities. Novasep’s engineering teams would be happy to work with you to implement the long-term manufacturing solution that best suits your individual needs.
The Le Mans site is also supported by Novasep multi-site, multi-disciplined organization including project management, sourcing, large scale competitive manufacturing for upstream non highly-potent intermediates, quality and regulatory compliance to provide cost-effective services tailored to your needs.
CERTIFICATION AND REGULATORY SUPPORT
Novasep’s practices for the controlled and safe manufacture of highly potent active pharmaceutical ingredients are recognized by SafeBridge® with certification renewed regularly since 2009.
The site has a quality management system run in strict compliance with current Good Manufacturing Practices. The robustness of this system is proven by the successful inspections by the FDA (last inspection in 2014) and other regulatory bodies (French ANSM, Japanese PMDA, etc.) as well as by our customers.
We also offer regulatory support including the submission of regulatory dossiers (DMF, CEP) with all the major health authorities.
Our kilolabs: a flexible scale-up capabilities to deliver up to few kilograms of GMP material
- use of portable equipment operated in contained unidirectional flow hoods.
- filtration, drying and packaging: handled either within isolators or with a filter dryer coupled with an isolator in a closed loop.
- industrial suites: multi-purpose equipment
- fixed isolators for powder loading and sampling
- pressure cascade design ensures the production workshop containment and anterooms allow for safe and controlled entrance and exit of personal, products, equipment and waste streams.
HPLC FOR ULTRA-PURIFICATION OF COMPLEX MOLECULES
The safe purification of cytotoxic compounds from complex mixtures is challenging whenever they are obtained from:
- synthesis with impurities closely related to the product
- hemi-synthesis starting from natural building blocks.
Our Prochrom® Preparative HPLC systems are particularly well suited to address this challenge, as they are designed for high containment. This allows for the safe and efficient purification of potent compounds with very low OEL, while maximizing purity and recovery yield.
Novasep is an expert in industrial scale HPLC, combining a strong know-how as an equipment designer as well as end-user of the technology. Thanks to advanced simulation software developed in house, the scale-up of HPLC is highly predictable: the performance of commercial processes can be reliably assessed very early in the development with only milligram scale experiments.