Novasep offers unique services for the cGMP manufacturing of antibody-drug conjugate components including the payload, the linker and the monoclonal antibody. The experience of our teams, combining in-house expertise in Highly Potent APIs (HPAPIs), biopharmaceuticals and chromatographic purification, makes Novasep your partner of choice for a successful ADC project.
We enjoy a long experience with a wide range of projects based on the main technology platforms (e.g. maytansins, auristatins, pyrrolo-benzodiazepines) and offer CMO services including process development, cGMP clinical lots and validation, as well as full commercial manufacturing.
Production of ADC payload and linker
With 25 years’ experience in the synthesis and HPLC purification of cytotoxics on an industrial scale, Novasep is particularly well positioned to meet the requirements of our customers for ADC payloads and linkers.
Due to their high toxicity, payload manufacturing at industrial scale requires specifically designed facilities for contained production activities. Novasep’s FDA-inspected Le Mans site is certified by SafeBridge® for the synthesis and purification of Category 4 compounds.
In 2014 we commissioned a new, dedicated manufacturing facility for the commercial cGMP production of payloads with an Occupational Exposure Level (OEL) of 0.03 µg.m-3.8h-1 and lower.
Check on our dedicated page to learn more.
Production of monoclonal antibodies
Novasep also proposes mAb manufacturing services from process development to commercial-scale production. Our highly-efficient processes and smart methodology will provide you with your mAb more quickly and more cost-efficiently. With a 15-year track record in cell culture and mAbs manufacturing, and around 10 projects every year, we have the experience you can trust.
Check our mAb manufacturing services to learn more.