Selection of a CDMO for drug product manufacturing is a significant decision to make for any pharmaceutical or biotechnology company seeking to bring complex parenterals to market. Does the CDMO have a strong technical background and Quality by Design principles to determine critical process parameters that will impact drug product manufacturing and performance of your API, excipients, drug delivery technology and process method? Has the CDMO demonstrated a track record to develop the most effective and scalable process for drug product manufacturing that will accelerate your path to market and reduce regulatory risk? Evonik combines several decades of experience in the development and manufacturing of specialized pharmaceutical drug products through its expert teams and advanced CDMO facilities in North America to fully support your requirements from benchtop to commercial scale.

Evonik is one of the world’s leading CDMOs for the drug product manufacturing of polymeric and lipid-based drug products including microparticles, nanoparticles, liposomes, drug-loaded implants, in-situ forming preparations and micelles. We have decades of expertise in the core process technologies that are used in the manufacturing of a range of small molecules, peptides, and nucleic acids (mRNA, siRNA, oligonucleotides), via continuous microencapsulation, precise hot melt extrusion, liposomal extrusion, microfluidics and micro-mixing. Our cGMP facilities in the U.S. and Canada enable terminal sterilization manufacturing as well as aseptic manufacturing in Grade A isolators at clinical and commercial scale. A full array of manufacturing support services is also available including process engineering, scale-up and technology transfer. Other analytical services include phase-appropriate method transfer, qualification and validation to ICH guidelines, and drug product release testing and stability studies. In addition to drug product manufacturing, our CDMO sites are licensed to handle high-potency APIs and controlled substances, and we are certified to ISO 13485, 9001 and 14001.

Our CDMO drug product manufacturing facilities in Birmingham in the U.S. State of Alabama are fully equipped to support the development, the sterile GMP production and the aseptic filling of a broad range of drug substances that are designed for extended release. Regardless of your benchtop, clinical or commercial batch requirements, Evonik’s Birmingham site represents an attractive, FDA-inspected CDMO site for drug product manufacturing of polymeric-based dosage forms. Our manufacturing capabilities include the production of polymeric nanoparticles and microparticles via continuous microencapsulation, and the production of drug-loaded implants via precise hot melt extrusion. For those seeking to strengthen security of supply, additional options include the supply of excipients from the same facility, or the production of polymeric nanoparticles from our cGMP manufacturing facilities in Vancouver, Canada.

Our CDMO site for drug product manufacturing in Vancouver, Canada has set the industry standard for the production of liposomal drug products for more than 30 years. Previously known as Transferra NanoSciences and Northern Lipids, this recently expanded CDMO site for the drug product manufacturing specializes in lipid-based drug products such as nucleic acids (mRNA, oligonucleotides etc.), as well as other specialized products including peptides, synthetic vaccines and immunotherapies. The site includes an ISO 7 compounding area, Grade A isolators to handle high potency APIs, and large-scale diafiltration systems and tray lyophilizers. Parenteral drug product manufacturing services include liposome formation, size reduction, purification and sterile filtration to ensure a rapid, reproducible and scalable process for the supply of batches from 1mL to hundreds of liters. For extrusion-based processes, our LIPEX® extruders are highly trusted by the industry for their ability to create homogeneous populations of liposomes at lab, pilot, intermediate and commercial-scale. We are also a CDMO specialist for the drug product manufacturing of liposomes via microfluidics and micro-mixing technologies. Other services include the development of analytical methods and stability testing. Also speak with us about the ability to transfer production to our Birmingham facility in the U.S. for Phase III and commercial volumes.