Evonik is one of the world’s leading CDMOs selected by pharmaceutical companies to help transform their APIs into complex parenteral drug products. Our CDMO portfolio of drug delivery systems comprises more than six established formulation technologies including lipid nanoparticles (LNPs), polymeric microparticles, nanoparticles, micelles, drug-loaded implants and in situ forming. In addition to having several decades of expertise as a CDMO for drug delivery systems, we are also an industry leader in the development and supply of parenteral excipients for extended release under our RESOMER® portfolio. This broad, integrated portfolio of drug delivery systems, excipients and value-adding services has helped countless customers to commercialize and differentiate their small molecules, peptides, proteins, nucleic acids (e.g. mRNA), vaccines and other drug substances or combination products.

Our significant CDMO expertise across multiple drug delivery systems allows us to recommend the best technology based upon your specific API, formulation and drug product requirements to address new treatment modalities across a wide range of therapy areas. In addition to the development of extended release formulations for systemic delivery over days, weeks, months or a year or more, we specialize in the localized delivery of drugs to body parts such as the knee or eye; the targeting of specific genes or disease sites; and drug-device combination products. Irrespective of the drug delivery system selected, our CDMO teams provide integrated formulation, process and analytical support from feasibility to the scale-up of the commercial drug product. With these teams able to leverage a Western-based network of audited, cGMP manufacturing sites and formulation and analytical labs, as well as dozens of other customer support offices worldwide, you can be assured of receiving reliable, responsive support.

The formulation and process development and manufacturing of gene-based drugs and other advanced nanomedicines that are reliant upon lipid nanoparticle (LNP)-based drug delivery systems can require a CDMO with extensive capabilities in this highly specialized area. Evonik’s team has been a CDMO drug delivery systems leader for LNP-based formulations for more than 30 years, with expertise across virtually all classes of pharmaceuticals. In addition to the development of more than 100 unique LNP-based formulations and strong regulatory knowledge across a range of markets, we are uniquely positioned to provide established process technologies including LIPEX® extruders and microfluidics. We can also provide a full range of analytical services to support drug development, as well as cGMP manufacturing and filling services to meet your clinical and commercial-scale requirements.

For polymeric-based drug delivery systems, Evonik is the only CDMO that can make or take your API, supply our own bioresorbable excipients for extended release, develop the formulation and then manufacture and fill the final drug-product. With a broad range of established polymeric technologies including microparticles, nanoparticles, implants and micelles, our CDMO drug delivery capabilities can help you to optimize drug product performance, boost patient compliance and differentiate your brand. Integrated formulation, process development and manufacturing capabilities are available to support any pre-clinical, clinical or commercial stage. Our multi-purpose, FDA inspected U.S. facility near Birmingham in the U.S. has recently been expanded to support growing customer demand, and features an extensive network of labs and cleanrooms. Our CDMO drug delivery systems expertise also extends across micro-encapsulation, nano-encapsulation and precise hot melt extrusion, and the selection and supply of the right excipient from our market-leading RESOMER® portfolio.