CordenPharma, a global CDMO manufacturing 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 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 aligns with 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.