Novasep has been a leading contract service provider in the ADC arena for more than 10 years. Today we propose a fully integrated supply chain for the cGMP manufacturing of ADCs, including bioconjugation, payload, linker & mAbs.
Our commitment to ADCs is underlined by the recent €10M investment in a stand-alone bioconjugation unit at our Le Mans site in France. This state-of-the-art facility will be operational from Q4 2016.
Novasep was short-listed in both 2015 & 2016 for the World ADC Awards in the category of Best Contract Manufacturing (CMO) Provider. The company was also rewarded at the CMO Leadership Awards with recognition in 5 categories.
Novasep’s offers a full range of process development, analytical and manufacturing services for bioconjugation in a new purpose-built facility*. Fully compliant with the highest standards in quality, health, environmental and industrial safety, the unit will support our customer’s needs from clinic to validation and launch.
The new unit comprises R&D & QC laboratories, proof-of-concept lab (20-40L) and parallel cGMP manufacturing streams (20-400L).
Our dedicated team provides expertise to support our customers’ projects over a wide range of ADC conjugation techniques including ‘next-generation’ and site-specific conjugation.
* The facility will be commissioned in Q1 2017; our laboratory is already operational for R&D activities.
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Production of ADC payload and linker
We offer a full range of integrated CMO services including process development, cGMP clinical lots and validation, as well as commercial cGMP manufacturing.
With 25 years’ experience in the synthesis and HPLC purification of cytotoxics at industrial scale, the team is particularly well trained and skilled to support our customers for their ADC payload and linker production projects.
Novasep team has worked on all of the main payload platforms (e.g. maytansins, auristatins, pyrrolo-benzodiazepines), and can support your projects at any scale of production.
Due to their high toxicity, payload manufacturing at industrial scale requires specifically designed facilities for contained production activities. Novasep has put in place detailed practices for the controlled and safe manufacture of highly potent active pharmaceutical ingredients.
Our 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 was commissioned in 2014.
The Le Mans site was successfully inspected by the FDA in May 2016.
Check on our dedicated page to learn more.
Production of monoclonal antibodies
Novasep is also recognized for its mAb manufacturing services.
With a 15-year track record in cell culture and mAbs manufacturing, our dedicated expert team can serve our customers from process development to commercial-scale production.
Check our mAb manufacturing services to learn more.