Evonik has manufactured the first batch of GMP-quality pharmaceutical lipids at its new Lipid Innovation Center (LINC) in Lafayette, Indiana, USA. Supported by the U.S. government*, the large-scale facility at Evonik’s Tippecanoe site will produce pharmaceutical lipids that enable the manufacture of advanced therapies in the U.S. Full capacity is scheduled to come on stream by mid-2027.
“Behind every batch of lipids we produce here are patients waiting for a therapy that could change their lives,” said Guido Skudlarek, head of the Health Care business line. “LINC is about ensuring that the next generation of RNA medicines can be developed and manufactured reliably, at scale, and within the U.S. We are proud to help strengthen America’s pharmaceutical supply chain and to contribute to the health and well-being of patients across the nation.”
LINC is a flexible production center designed to support multiple lipid chemistries, manufacturing processes and products. These therapies are used in areas such as cancer immunotherapy, gene therapy, and vaccine platforms that support preparedness for future infectious disease outbreaks.
Lipids are essential for encapsulating and delivering nucleic acid-based drugs such as mRNA. Proven in COVID-19 vaccines, lipid nanoparticles (LNPs) have become a leading delivery system, and the LNP market alone is estimated to reach US$2.7 billion by 2034. The first product from the new center is PhytoChol®, a non-animal-derived cholesterol and essential excipient for LNPs.
LINC is integral to Evonik’s strategy to lead the market in lipid-based drug delivery technologies, complementing the company’s strong positions in oral and parenteral drug delivery and in pharmaceutical CDMO services. It is part of an integrated global network that combines expertise in lipid chemistry, LNP formulation, process engineering, sterile manufacturing and regulatory affairs to support customers from early-stage development to commercial supply.
Together, these facilities provide an integrated pathway from formulation development through clinical manufacturing and commercial supply. Evonik Vancouver Laboratories develops LNP formulations and supports clinical manufacturing, with an investment in a new GMP facility announced in August. Late-stage clinical and commercial processes are transferred to Birmingham, Alabama, USA, while the sites in Dossenheim and Hanau in Germany, and now also Tippecanoe, Indiana, USA, supply lipids and adjuvants. The Cambridge Innovation Satellite in Greater Boston, USA, adds R&D capabilities.
