As a pharmaceutical innovator, manufacturing your new API may seem both complex and challenging. You will need expertise for developing and optimizing a robust, transferable, and scalable process to support long-term production.
Novasep can bring its extensive process development experience to your drug substance from technical and analytical transfer to process optimization and validation. We offer a full range of CDMO services for your APIs, with an emphasis on quality, speed, and flexibility.
A demonstrable expertise in API process development and scale-up
Novasep has been offering CDMO development & manufacturing services for APIs for more than 30 years.
With more than 50 process steps transferred from R&D to manufacturing each year, Novasep is recognized for its process development know-how. Our strong expertise in DoE (Design of Experiments) enables to increase process robustness, to ease production scale-up, and therefore accelerate timelines to answer your needs.
An extensive toolbox of technologies coupled with our strength in process chemistry, allows our teams to develop and implement innovative new generation processes, enabling us to extend product lifecycles.
Discover the top 6 reasons why customers choose Novasep as a CDMO partner:
Did you know?
- Novasep has been recognized as one of the Top Pharma Outsourcing companies in Europe in 2021:
- Novasep has been nominated by CIO Review as one of the most promising CDMOs in 2021. Discover Novasep's approach explained by Jin Seok HUR, General Manager of Novasep’s Wilmington (DE) US site!
Our CDMO services for API development
From the production of the first grams of your small molecule drug substance to several kilos, Novasep offers a full range of early phase process development and scale-up services for APIs. We can combine innovative synthesis and purification to design more efficient processes to add value and increase capacity.
Process development to scale up
- Technical transfer
- Process development & scale-up
- Analytical methods development and optimization
- Process safety assessments
"Novasep’s experts helped us a lot to overcome technical problems in the process over the past few years", Big pharma
Process Validation
- Validation of analytical methods
- Validation of equipment cleaning methods
- Regulatory support
- Validation of manufacturing process
- Preparation of validation report
Novasep provides services all along your API journey, to routine commercial production.
Find out more about our process development expertise and approach for APIs by downloading our dedicated posters:
 |
Process safety assessment |
|
Process modeling |
|
Statistical tools for process development |
|
Impurities management along the process development lifecycle |
|
Continuous Flow Chemistry |
Our facilities for API development
Our network of 6 sites, at the heart of Europe and in the U.S., is strongly supported by a team of committed chemistry professionals.
Sites |
Process development |
Kilolab manufacturing |
Pilot manufacturing |
Process validation |
|
|
X | X | X | X |
|
|
X | X | X | X |
|
|
X | X | X | X |
|
|
X | X | X | X |
|
|
X | X | X | X |
|
|
X | X | X |
Novasep offers purification development services from its Pompey & Chasse-sur-Rhone facilities in France, and its Wilmington site in the USA, including screening & process development using Novasep’s designed preparative chromatography technology.
Our Leverkusen site develops processes including hazardous chemistry steps.
In addition, Novasep's Le Mans site in France supports the early phase development of HPAPIs & cytotoxics as well as Antibody Drug Conjugates (ADCs). The site combines synthesis and HPLC chromatography of Band 4 compounds (Safebridge®).
Our facilities are closely connected and benefit from shared resources for Project Management or R&D.
All our sites have been recently inspected by the National Authorities and the FDA: learn more about our excellent regulatory history in our Pharma brochure:
