CordenPharma, a global CDMO leader in the manufacture of Drug Substances (APIs) for complex modalities (such as peptides, GalNAc, lipids, etc.), Lipid NanoParticles (LNPs) containing xRNA / xDNA, and injectable Drug Products, and Certest, a Spanish company focused on the development of new products with special emphasis in Drug Delivery with LNPs and API synthesis, have signed a partnership agreement.
The partnership, signed on 7 May 2024, aims to add ionizable lipids to CordenPharma’s complex LNP formulation services, the missing key element needed to close the gap in its formulation offering to support biotech and pharmaceutical companies with the development, discovery, and manufacturing of xRNA / xDNA from early clinical phase to commercial. The partnership complements CordenPharma’s recently announced strategy to address targeting with peptide-decorated LNPs, and opportunities to enhance mRNA transfection with β-sitosterol.
Under the terms of the agreement, Certest will provide access to their unique ionizable lipids platform, well supported by in vitro / in vivo and tox data. In the alliance, thanks to its four decades of experience in lipids development and manufacturing, CordenPharma will leverage cGMP manufacturing capacities, regulatory know-how, and market access to ensure high-quality GMP supply for their customers’ journey to market.
Dr. Matthieu Giraud, CordenPharma’s Senior Director, Global Lipids & Carbohydrates Platform, commented: “Many therapeutic domains can benefit from the newly introduced LNP formulation that proved to be successful during the pandemic. At CordenPharma, we aim to consider independently each of the four pillars of an LNP formulation, namely the lipid functional excipients, to provide our customers with the most effective support in solving their therapeutic formulation challenges. This partnership augments our offer with a lean and attractive approach to LNP formulation that also reduces the growing IP challenges in the market.”
Nelson Fernandes, CEO of Certest, commented: “The world of lipid nanoparticles is revolutionizing the pharmaceutical industry today. The results have been overwhelmingly positive, and advancements in the formulation of LNPs, along with the development of a robust library of ionizable lipids, are set to redefine the paradigm of the current situation.
At Certest, we offer a powerful delivery platform, thanks to our ionizable lipids, that will enable clients to overcome nearly all therapeutic challenges. This collaboration is going to be a significant advancement for our clients.”
