CordenPharma, Certest Partner on Ionizable Lipids in LNP Formulation

CordenPharma, a global CDMO 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 developing new products 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 complements CordenPharma’s recently announced strategy to address targeting with peptide-decorated LNPs, and opportunities to enhance mRNA transfection with β-sitosterol.

Under the agreement, Certest will provide access to their unique ionizable lipids platform, supported by in vitro / in vivo and tox data. CordenPharma will leverage cGMP manufacturing capacities, regulatory know-how, and market access to ensure high-quality GMP supply to support customers products to market.

Dr. Matthieu Giraud, CordenPharma’s Senior Director, Global Lipids & Carbohydrates Platform, said, “Many therapeutic domains can benefit from the newly introduced LNP formulation that proved to be successful during the pandemic. 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, said, “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.

PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.

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