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HPAPI manufacturing
Safe, compliant HPAPI manufacturing for both cytotoxic and non-cytotoxic highly potent compounds, supported by dedicated OEB5 and OEB6 facilities across Europe.
Experts in high potency API manufacturing
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 clinical & commercial supply covering both cytotoxics and non-cytotoxic HPAPIs. Supported by advanced containment technologies and a European network of specialized facilities, we mitigate risk while ensuring speed to market for your sensitive programs. Our expertise spans both established modalities such as ADC payloads and linker-payloads, and emerging targeted protein degradation (TPD) therapies including PROTACs, molecular glues and protein degraders.
Our 2 HPAPI centers of excellence
Our Le Mans site, located in France, is our Center of Excellence for ADCs. It supports the development and manufacturing of highly potent ADC payloads, linker-payloads and bioconjugates, helping customers advance next-generation targeted therapies:
- OEB6 containment (<10 ng/m³/8hr)
- Batch size from 30 g to 1.5 kg
- Process development and scale-up
- Clinical and commercial cGMP manufacturing
- On-site lyophilization capabilities
- HPLC from 50 to 450 mm columns
- Regulatory & cGMP expertise
Explore our ADC Payload expertise and capabilities
Our Gropello site, located near Milan in Italy, can support the development and manufacturing of highly potent non-cytotoxic compounds, including protein degraders, molecular glues and PROTACs, in three dedicated state-of-the-art workshops:
- OEB5 containment (>100 ng/m³/8hr)
- Batch sizes from 1 to 300 kg
- Process development and scale-up
- Clinical and commercial cGMP manufacturing
- On-site micronization capabilities
- Regulatory & cGMP expertise
Supporting Emerging Therapeutic Modalities
Leveraging decades of HPAPI experience and advanced containment, Axplora supports the manufacture of next-generation highly potent compounds, including targeted protein degradation therapies such as PROTACs, molecular glues and protein degraders.
The manufacturing of protein degraders often requires specialized technologies, including chromatographic purification. As a recognized leader in preparative chromatography for API manufacturing, Axplora provides tailored purification solutions to support the development and scale-up of these complex molecules.
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Discover more of our expertise in complex manufacturing.
ADC Payloads
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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 […]
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Work with a trusted HPAPI manufacturing partner.