Lipid nanoparticles ensure that pharmaceutical active ingredients are only released when they reach their specified destination. As essential components of mRNA therapeutics, they could play a crucial role in advancing the treatment of infectious diseases or cancer. Evonik is a global leader in the development and production of these drug delivery systems. Its customers in the pharmaceutical sector benefit from comprehensive services along the entire value chain.
mRNA technologies are revolutionizing medicine, not only in the struggle against infectious diseases but also in cancer immunotherapy, protein replacement therapy, and gene therapy. All of these innovative drugs are based on the same fundamental concept: Ribonucleic acids, or RNA for short, either deactivate specific individual genes, or enable the synthesis of essential proteins, or trigger a desired immune reaction. For this to work, the RNA molecules must make their way directly into the targeted cells of the affected tissue. “Strands of RNA are relatively unstable,” says Dr. Andrea Engel, who is responsible for growth projects at Evonik’s Health Care business line. If they were injected directly into the bloodstream, they would be broken down rapidly. So there is a need for transport mechanisms that can convey their pharmaceutical freight directly into the interior of the cells.
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LIPID NANOPARTICLES ARE A SOURCE OF HOPE FOR MODERN MEDICINE
One of the most advanced drug delivery systems uses lipid nanoparticles (LNPs), which consist of a combination of various lipids. As building blocks of living cells, they enclose the mRNA and make it invisible to the immune system. In this way they ensure that the active ingredient remains undamaged and is only released at its specified destination. LNPs demonstrated how well they perform this task during the COVID-19 pandemic, when they were used as essential components of mRNA-based COVID-19 vaccines. “Lipid nanoparticles have been regarded for quite a while now as a great source of hope for medicine, because they are smoothing the path toward medications that are tailored to the individual patient,” says Engel. “Before the COVID-19 pandemic, they were already used to make the active ingredients in cancer medications more tolerable for patients, for example.”
As a partner of the pharmaceutical industry, Evonik is a leader in the development and production of modern delivery systems for active ingredients such as LNPs and pharmaceutical excipients such as lipids. The company’s expertise in this area is concentrated in the Health Care business line, which supports pharmaceutical companies all over the world with comprehensive services along the entire value chain. “We’re developing new customized lipids, we can formulate active ingredients such as mRNA in LNPs, and we are proficient in the development of the relevant processes,” says Engel. She adds that Evonik has at its disposal experienced engineering teams who scale up the manufacture of small batches of a product in the laboratory to stable industrial processes that turn out bigger quantities. “At our company, customers receive everything from a single source,” Engel says.
We’re developing new customized lipids, we can formulate active ingredients such as mRNA in LNPs, and we are proficient in the development of the relevant processes.
WORLDWIDE PRODUCTION OF DRUG DELIVERY SYSTEMS AND PHARMACEUTICAL EXIPIENTS
Evonik realized early on that innovative approaches to therapy such as the use of mRNA vaccines have great potential. Since 2016 it has been developing and formulating lipid nanoparticles in the town of Burnaby near Vancouver (Canada). It also operates a plant for the production and filling of commercial volumes of LNPs in Birmingham, Alabama (USA). And at the beginning of 2020 it expanded its portfolio by acquiring Wilshire Technologies, an American producer of plant-based excipients for the pharmaceutical industry.
Germany is also an important production location. During the COVID-19 pandemic, Evonik quickly built two production facilities for specialty lipids in Hanau and Dossenheim, thus playing an important role in the supply security of the COMIRNATY(R) vaccine against COVID-19. In 2023 it also opened a facility for the production of smaller batches of lipids in Hanau. This facility is tailored to meet the requirements of pharmaceutical and biotech companies that need customized lipids in quantities of just a few kilograms for their clinical trials or for launching innovative drugs on the market.
In Tippecanoe we will not only produce lipids in different orders of magnitude but also be able to handle various aspects of lipid production—from dosing the raw material all the way to packaging the final product.
A FACILITY FOR PRODUCING PHARMACEUTICAL LIPIDS ON A GLOBAL SCALE
In order to expand its product range and safeguard its ability to supply critical starting materials in situations such as a new pandemic, Evonik is currently building a highly flexible facility for producing pharmaceutical lipids on a global scale at its Tippecanoe location in Lafayette, Indiana (USA). Zeinab I. Aly, a process engineer at Health Care who is involved in the project, says, “Here we will not only produce lipids in different orders of magnitude but also be able to handle various aspects of lipid production—from sourcing and reacting the starting materials all the way to packaging the final lipid material.” Tippecanoe is one of the world’s largest facilities for the production of pharmaceutical active ingredients. Thanks to the local infrastructure, the highly qualified workforce, and the available technologies, it provides the ideal preconditions for the new construction project.
PROJECTS FOR EXPLORING INNOVATIVE DRUG DELIVERY SYSTEMS
In order to forge ahead with research on innovative drug delivery systems, Evonik cooperates with partners from industry and scientific institutions all over the world. For example, since January 2023 Evonik has been a participant in a project supported by the German Federal Ministry for Economic Affairs, in which universities and companies jointly develop new specialty lipids for mRNA therapeutics. In addition, Evonik is collaborating with Stanford University in California to develop a polymer-based drug carrier system for mRNA. A joint project with the University of Mainz is also promising. “Our focus here is on what are called rPEG lipids,” says Engel. “This especially efficient transport system for mRNA therapeutics could give a further boost to the struggle against diseases such as cancer, multiple sclerosis, and Alzheimer’s.”