Evonik Industries AG (Essen, Germany) has officially begun construction of its $220 million global-scale production facility for pharmaceutical specialty lipids in Lafayette, Indiana, in the United States. The new facility is expected to secure the industry’s access to critical excipients needed for mRNA vaccines and other nucleic acid therapies. The plant is scheduled to go onstream in 2025.
“Our new Lipid Innovation Center will secure the health innovations of tomorrow. Through this investment, we reinforce our leading position in the pharmaceutical industry. We are privileged to support the U.S. with pandemic preparedness and enable the development of cutting-edge medicines,” said Christian Kullmann, CEO of Evonik.
During the COVID-19 pandemic Evonik emerged as a key player in securing the availability of functional excipients for leading vaccine producers. Evonik’s Health Care business is part of the life sciences division, Nutrition & Care, which also encompasses the company’s Care Solutions and Animal Nutrition businesses and leverages a strong biotechnology platform.
“This new world-scale facility will enhance Evonik’s unique position as a CDMO in the pharmaceutical industry. Be it development quantities or large scale, be it formulation or fill-finish – our partners in the RNA drug space can rely on us along the entire process,” said Johann-Caspar Gammelin, president of the Nutrition & Care division at Evonik.
The total investment into the commercial-scale lipid facility amounts to $220 million. The U.S. Government has entered a cooperative agreement with Evonik for a cost share of up to $150 million through its Biomedical Advanced Research and Development Authority (BARDA), a component of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS). BARDA coordinated acquisition assistance with the Department of Defense (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND).
Evonik’s Lipid Innovation Center will be built on the grounds of Evonik Tippecanoe Laboratories, which is one of the world’s largest contract manufacturing facilities for active pharmaceutical ingredients (APIs) and Evonik’s second-largest site in the U.S. The new flexible development and manufacturing facility will allow for the rapid scale up and manufacturing of a variety of specialty lipids following high quality standards to serve future applications of RNA technology in infectious disease control, cancer immunotherapy, protein replacement, and gene therapy.
Earlier in March 2023, Evonik opened a new cGMP facility in Hanau, Germany to develop and manufacture smaller batches of lipids. This Lipid Launch Facility will provide customers with the necessary quantities of lipids for clinical and small-scale commercial manufacturing. This facility complements Evonik’s existing lab and commercial production network, which includes formulation capabilities in Vancouver, Canada, and manufacturing and fill-finish capabilities in Birmingham, Alabama in the U.S.
The groundbreaking ceremony for the Indiana-based Lipid Innovation Center on March 29, 2023, was attended by representatives of the federal government, the Governor of Indiana, Eric Holcomb, and local officials of the greater Lafayette area, who joined Evonik’s CEO Christian Kullmann and members of the company’s Management and Supervisory Board.