Three real-life case studies: CMO services for custom polymers  

When a customer chooses a Contract Manufacturing Organization (CMO) to manufacture a polymer for a pharmaceutical or medical device project, they are looking to minimize the unexpected and accelerate time to market. At Evonik, we provide contract manufacturing and development services tailored to meet the specific needs of our clients in the pharmaceutical and medical device industries. With over 60 years’ experience in the design, synthesis and supply of high-quality polymers, we offer companies a safe and dependable option for outsourcing their proprietary biomaterials.  

In this article, we take you through three case studies that provide real-world examples of how Evonik has served customers in meeting their polymer manufacturing needs.  

Over nearly seven decades, Evonik has built up a unique level of expertise in acrylic polymers. One of the most established brands in functional excipients for oral dosage forms is EUDRAGIT®. These excipients are used to release active pharmaceutical ingredients (APIs) at specific sites in the gastrointestinal tract and over the desired period of time. They also improve the bioavailability and stability of APIs in oral medications. 

Evonik has production sites for acrylic polymers in Darmstadt and Hanau in Germany, where we use various radical polymerization techniques, including suspension polymerization, bulk polymerization, emulsion polymerization and solution polymerization. Evonik also offers advanced solutions such as reactive resins and ATRP. With over 60 acrylic monomers available at commercial scale and 380+ acrylic monomers at pilot-or lab scale, Evonik has an extensive range of options for polymer development.

Case example 1: Spray-dried acrylic excipient 

We worked with a customer to characterize their polymer and establish a product specification for reliable supply, including latex particle size and distribution (PSD), molecular weight (MW), polydispersity index (PDI), glass transition temperature (Tg), and residual monomer.  

To improve robustness and regulatory compliance, we adjusted the components, scaled up the emulsion polymerization process, and developed an optimized downstream process.  

The process development included scale-up from lab scale (1 L and 9 L) to pilot scale (1000 L) to GMP scale (>10 MT), while maintaining the desired release profile of the polymer.  

Cationic polymers are used for polymeric nanoparticles (PNPs) for gene delivery applications such as RNA/DNA vaccines and nucleic acid-based therapeutics. PNPs are an alternative to LNP formulations that include cationic lipids. Evonik has experience with polyamine polymers and offer full CDMO services for parenteral dosage forms based on such polymers. In addition to offering custom manufacturing of cationic polymers, Evonik also offers PNP formulation services based on a proprietary platform (CARTs, Charge-Altering Releasable Transporters, see here). 

Case example 2: PEI-bearing gene delivery carrier 

At our site in Birmingham, Alabama in the U.S., Evonik developed an amphiphilic gene delivery carrier in collaboration with a customer. The process was scaled-up and modified to enhance organic solvent handling and operator safety. As a result, the target compound was successfully produced in GMP grade and transferred to the customer in time to support a clinical study. This achievement demonstrates Evonik's commitment to innovation and customer satisfaction. 

Degradable materials for medical devices can be designed e.g. from polyesters, polyamides, polyurethanes, and polycarbonates. Depending on the specific use, tissue compatibility and mechanical strength need to be adjusted to create the desired material characteristics. 

Case example 3: Tyrosine derived polycarbonate 

In this project, we used the natural amino acid L-tyrosine as a building block to develop polymers with tailored mechanical strength. In collaboration with a customer, Evonik co-developed a process that resulted in the creation of desaminotyrosyl-tyrosine monomer. The polymer was then successfully produced and deprotected under GMP conditions. Evonik also synthesized several analogous polymers with varying hydrophilic/hydrophobic balance. 

Evonik offers customized solutions tailored to the specific needs of each customer. This can include process development, scale-up, validation, commercial manufacturing, and any combination thereof. Our customers come to us for our strong commitment to quality and compliance and our track record developing and commercializing innovative polymer-based products. With manufacturing facilities and technical centers located around the world, we can provide local support and expertise wherever you are located.  

If you have a question about the case studies or would like to discuss a project, please get in touch: healthcare@evonik.com