API development services
API development services
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.
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
Process Validation
- Validation of analytical methods
- Validation of equipment cleaning methods
- Validation of manufacturing process
- Preparation of validation report
