24/7 BIOPHARMA - issue 1 / October 2024

CORDENPHARMA

specialised custom and catalog lipid synthesis, and extensive oral drug product services, we are confident customers will discover the unique potential that comes with a fully-integrated, bespoke service offering a truly end-to-end experience.

Lipids & Carbohydrates platform: driving the creation of new complex modalities.

CordenPharma stands as a global leader in pioneering lipid-based products for

pharmaceutical development. With a remarkable track record over four decades, it has collaborated extensively with the research, pharmaceutical and diagnostic sectors to deliver cutting-edge solutions that push the boundaries of science and support pharmaceutical innovators’ complex modalities for their life-saving medications. CordenPharma’s continuous pursuit of specialised lipid innovation has resulted in an expanded 2024 portfolio of diverse custom and catalog lipids that draw upon our legacy of excellence in synthetic lipid process development. As a leader in the scale-up and large-scale manufacturing of commercial lipids, CordenPharma is an early innovator holding Drug Master Files (DMFs) on some of the industry’s most utilised lipids that have been proven efficient and effective for Lipid NanoParticle (LNP) formulation. Our ongoing, substantial capital investment and development efforts in custom lipid synthesis are demonstrating efficacy and utility in delivering advanced complex RNA therapeutics. CordenPharma supports mRNA vaccine development with four classes of high purity lipids required to formulate LNPs: 1. Cationic/ionisable lipids that interact with the negatively-charged nucleic acids to encapsulate and enhance cellular internalisation. 2. PEGylated lipids/PEG free polymer as an alternative system for therapeutic applications (CordenPharma’s IP for reduced immunogenicity purpose) that help increase stability and half-life and prevent aggregation. 3. Phospholipids (helper lipids) that form the surface membrane of LNPs. 4. Sterol that enhances membrane fluidity, including BotaniChol ® (CordenPharma’s non-animal origin cholesterol), beta-sitosterol, stigmasterol, and sitostanol. High-purity, complex lipids play an increasingly significant role in today’s xRNA/DNA pharmaceutical development landscape. As part of this long-term strategy, CordenPharma completed the expansion of our specialty lipids production at CordenPharma Chenôve, France, integrating Supercritical Fluid Chromatography (SFC) technology for compound

Video highlighting CordenPharma’s LNP

Starter Kits for effective mRNA formulation.

[CordenPharma Photo] - GMP production of a complex commercial COVID-19 lipid using green and highly efficient Supercritical Fluid Chromatography (SFC) technology.

separation. The beauty of SFC technology is that it does not use organic solvents, is a much faster process and allows for the direct recycling of over 95% of the CO 2 used. CordenPharma Caponago has completed a €15 million investment for the cGMP manufacture of Lipid NanoParticles (LNPs) and other Nanoparticles such as Polymeric and Peptide Nanoparticles.

Injectables platform: fully integrated cGMP manufacturing of LNPs.

22 TWENTYFOURSEVENBIOPHARMA Issue 1 / October 2024