CordenPharma Partners with Certest to Develop Ionizable Lipids for LNP Formulations

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Switzerland-based CordenPharma, a contract development and manufacturing organization, announced on June 6, 2024 that it has partnered with Certest, a Spain-based company focused on lipid nanoparticle (LNP)-based drug delivery and API synthesis, to develop a portfolio of ionizable lipids for LNP formulations.

CordenPharma specializes in the manufacture of drug substances for complex modalities, such as peptides, N-acetylgalactosamine (GalNAc), and lipids, among others; LNPs containing xRNA/xDNA; and injectable drug products. Under the partnership, signed in May 2024, Certest will provide CordenPharma with access to its ionizable lipids platform, which, when combined with CordenPharma’s complex LNP formulation services, is expected to boost CordenPharma’s ability to support the development, discovery, and manufacturing of xRNA/xDNA therapeutic candidates from early clinical phase to commercial.

“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,” said Nelson Fernandes, CEO of Certest, in a company press release.

Certest’s ionizable lipids platform is supported by in-vitro/in-vivo and toxicology data. Through the partnership, CordenPharma will apply its current good manufacturing practice (CGMP) capacities, regulatory know-how, and market access with the aim of ensuring a high-quality GMP supply.

“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,” said Matthieu Giraud, senior director, Global Lipids & Carbohydrates Platform, CordenPharma, in a company press release. “This partnership augments our offer with a lean and attractive approach to LNP formulation that also reduces the growing IP [intellectual property] challenges in the market.”

The partnership complements CordenPharma’s strategy to enhance a therapeutic’s targeting mechanism using peptide-decorated LNPs as well as opportunities to enhance messenger RNA transfection using β-sitosterol (1). In February 2024, the company also launched new LNP Starter Kits for the formulation of mRNA-based therapeutics (2).

References

1. CordenPharma. Launch of Innovative LNP β-sitosterol Process Supports Sustainable Emission Reduction Targets. Press Release, April 17, 2024.
2. CordenPharm. CordenPharma Launches LNP Starter Kits to Mitigate Loss of High-value Payloads During the Gene Editing Journey to Market. Press Release, Feb. 28, 2024.

Source: CordenPharma