Home / Novasep CDMO / Services / API Development
API development
Streamlined development support
Bringing complex APIs from development to scale requires strong process expertise and regulatory support. With a team of 140+ specialists in process development and over 150 analytical method validations annually, we ensure effortless technology transfer and comprehensive regulatory support to propel your molecule toward commercial success.
Why partner with us?
- Proven expertise in complex molecules and HPAPIs (up to OEB6).
- 5cGMP sites in our European network.
- 100% regulatory inspection track record.
- 60% of our new projects originate from biotechs, proving our ability to adapt to innovator needs.
Seamless scale-up to supply
We minimize risk and accelerate timelines by smoothing the transition from early development to commercial manufacturing. Supported by a >€150M investment in modernized capacity, our integrated teams reduce complexity and keep projects on track.
Explore related services
Learn more about how we support complex projects end to end.
API Manufacturing
Latest news from Novasep CDMO
Brochure
Charting a course for peptide therapeutic purification success
Purifying peptide APIs isn’t just a step. It’s a science of manufacturing. So, how can pharmaceutical companies overcome specific hurdles of peptide manufacturing, pairing upstream process strategies with robust downstream processing? At Axplora, we’ve built our name, through our heritage, solving the hardest purification challenges with speed, reliability, and imaginative precision. From lab to large-scale, we turn complexity […]
Whitepaper
Whitepaper – Exploring Kinase Inhibitors
Exploring Kinase Inhibitors: A CDMO Perspective The whitepaper highlights how protein kinases, which regulate various cellular functions and include about 560 enzymes in the human genome, are linked to cancers and other disorders. Since 2001, over 75 small molecule kinase inhibitors (SMKIs) have been approved by the FDA, primarily for oncology, and new areas are […]
Presentation recording
Safe HPAPI manufacturing: Thinking outside the glovebox!
Learn more about HPAPI manufacturing! Duration: 23min Would you like expert guidance on key safety considerations for your next HPAPI manufacturing project? To learn more about the highly potent manufacturing, watch the recording of our presentation given at the 3rd annual HPAPIs: Containment & Handling Summit 2023! What will you learn in this video? Speakers: […]
Get in touch
Ready to launch your project? Discuss your development needs with a team that has delivered >250 successful transfers.