EUROAPI supports Sanofi’s mRNA vaccine platform
with the development of lipid nanoparticles
EUROAPI, the European CDMO announced by Sanofi in February 2020, has expanded its collaboration with the French group under the umbrella of their Master Agreement for Development and GMP Manufacturing Services, dated October 1, 2021, to support Sanofi’s mRNA vaccine platform with the development of lipid nanoparticles. As part of this collaboration, EUROAPI will develop and optimize innovative chemical synthesis routes and manufacture GMP batches for several second-generation cationic lipids through its CDMO activity. As such, EUROAPI will focus on lipids that are currently being tested as part of Phase I/II clinical trials that will support Sanofi’s mRNA vaccines platform, targeting indications including Flu.
“We are delighted to announce the expansion of our agreement with Sanofi for mRNA vaccines development as part of our CDMO activity. This collaboration is key for EUROAPI as it further evidences EUROAPI’s capabilities as well as confirms that the acceleration of CDMO activity is a strategic priority for the Group. We are extremely proud to continue being a partner of choice for Sanofi and look forward to working together in this promising project” said Cécile Maupas, Chief CDMO Officer, EUROAPI.
“Our innovative and differentiated technologies coupled with our heritage in complex chemistry are providing a solid base for our next generation lipids CDMO offering which is currently expanding to other partners worldwide”, added Kai Rossen, Chief Scientific Officer, EUROAPI.
Through its CDMO activity, leveraged by strong capabilities in its Budapest and Frankfurt development and manufacturing sites, EUROAPI is a global leader in lipid nanoparticles which are the key delivery enabler technologies for mRNA vaccines. Lipid nanoparticles play a crucial role in their ability to encapsulate, protect and transport mRNA to the cells where it will exert its therapeutic activity.
EUROAPI will leverage its development and production capabilities in organic chemistry to provide Sanofi with clinical materials’ supply. With 330 scientists, EUROAPI benefits from unique expertise in complex chemistry, analytics and regulatory, enabling it to find the right synthesis pathway in a swift manner and meet health authorities’ regulatory and quality requirements. The company is also equipped with state-of-the-art technology including large-scale chromatography purification equipment on its Budapest and Frankfurt sites that complies with the cGMPs allowing it to produce superior quality lipids. portfolio.
The CDMO activity is a strategic priority for EUROAPI and is expected to reach ~35% of its total net sales by the end of 2025. It has already obtained promising results since the establishment of a dedicated CDMO business development team in 2021, with 26 new projects won at the end of January 2022 spanning from 10 projects in pre-clinical/Phase 1, 6 projects in Phase 2, 4 projects in Phase 3 and 6 projects at commercial stage. The company is engaged in ten projects to develop and/or manufacture new molecular entities in the Sanofi’s R&D and combines Sanofi’s API commercial and development activities with six of its European production sites: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France).