Home / Novasep CDMO / Services / HPAPI Manufacturing
HPAPI manufacturing
Safe, compliant HPAPI manufacturing up to OEB6, supported by >$20M in recent site investments, world-class containment, and a 100% regulatory inspection track record.
Experts in potency
Developing high-potency APIs (HPAPIs) requires specialized containment and regulatory expertise. Handle your most potent molecules with confidence. Novasep CDMO provides reliable scale-up and commercial supply for HPAPIs and cytotoxics. Supported by advanced containment technologies and a European network of specialized sites, we mitigate risk while ensuring speed to market for your sensitive programs.
Why choose us?
- Handling capabilities up to OEB6 (nanogram levels).
- Recent $20M investment in bioconjugation and HPAPI suites at Le Mans.
- 100% regulatory inspection track record across our network.
- Dedicated commercial-scale units for cytotoxics and linker-payloads.
- Proven ability to scale complex potency from grams to commercial supply.
Safe handling, proven results
We combine technical depth with operational discipline to handle the most potent APIs safely. With specialized bioconjugation assets and rigid containment protocols, our Le Mans center of excellence ensures regulatory compliance and timely delivery for your project.
Explore related services
Discover more of our expertise in complex manufacturing.
API Development
Latest updates
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: […]
Leaflet
The partner of choice for HPAPIs
Looking for a CDMO partner with a proven track record for manufacturing of your HPAPIs? Axplora has more than 30 years’ experience in the manufacturing of HPAPIs & cytotoxics with more than 300 commercial & clinical cGMP batches produced. We offer a full range of high potency manufacturing services, from process development to cGMP production. What […]
Get in touch
Work with a trusted HPAPI manufacturing partner.