Lessons In Scaling Lipids Production And Purification

Prior to 2020, lipids were mainly needed in pharmaceutical formulations to help solubilize large molecules for injection. 
Until recently, complex lipids as components in a range of innovative mRNA drug products only made up a small portion of the market. However, through increased demand for more complex lipids utilized in new medicines and advances in drug research and development, this segment of the lipids market is expected to quickly grow.

In particular, mRNA-based therapeutics used in vaccines and explored for the treatment of cystic fibrosis, atherosclerosis, and a variety of cancers, contain lipid components. Because of the need to solubilize mRNA, protect it from degradation, and build a delivery vehicle so it can reach its cellular targets, complex lipids require development expertise and manufacturing capacity to develop and produce.

The speed at which the pharmaceutical industry is now developing and manufacturing mRNA drug products at large scale is nothing short of astounding; yet it has highlighted supply chain vulnerabilities — developmental capabilities and dedicated production facilities with skilled workers — to make the required pharmaceutical ingredients such as lipids.

In this article, explore the need for a CDMO partner capable of a wide range of services, from support for drug discovery programs all the way to large-scale commercialization, as well as the future opportunities for lipids.