A Market Leader for Parenteral Excipients and other Pharmaceutical Biomaterials
An integrated portfolio of pharmaceutical biomaterials and custom polymer synthesis services
Evonik is a global leader for pharmaceutical biomaterials, with more than six decades of parenteral drug delivery expertise across the development, supply or contract synthesis and manufacturing of bioresorbable polymers. A large number of controlled release as well as long-acting injectable formulations developed by and with us are making a difference in millions of patient lives. Customers can benefit from our integrated portfolio of CDMO services to help to ensure pharmaceutical biomaterials are synchronized with the API and relevant formulation and process technologies to ensure the finished drug product is safe and efficacious for use, and reproducible for clinical and commercial scale-up. These pharmaceutical biomaterials and associated services are used by customers worldwide across a range of drug types, therapies and application areas. In addition to the development and supply of our own pharmaceutical biomaterial brands such as RESOMER®, we can also support customers in the custom synthesis of their own proprietary polymers at our manufacturing sites in the U.S. and Germany.
RESOMER® portfolio of pharmaceutical biomaterials for biocompatibility, safety and supply security
The RESOMER® portfolio of pharmaceutical biomaterials has been delivering safety, biocompatibility and supply security to companies with complex parenteral drug products for more than 30 years. Being 100% bioresorbable and completely metabolized by the body, ideal for terminal sterilization and with a shelf life exceeding five years, RESOMER® parenteral excipients are highly suitable for use with small molecules, peptides, proteins and other substances. This portfolio of pharmaceutical biomaterials can be supplied from modern, established manufacturing sites in the U.S. and Germany, providing extensive options for dual sourcing or to optimize supply security. Our record for pharmaceutical biomaterials excellence is further underlined by our ISO 9001 and 13485 certifications, and compliance with IPEC-GMP Guide for Pharmaceutical Excipients 2014.
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A broad excipient selection of pharmaceutical biomaterials for the extended release of parenterals
More than 20 high and low-molecule weight grades of Poly (D,L-lactide) and Poly (D,L-lactide-co-glycolide) are available within the standard RESOMER® portfolio of pharmaceutical biomaterials, as well as PLA-PEG copolymers and condensates. The RESOMER® Select portfolio of pharmaceutical biomaterials can be custom-made to address specific excipient requirements and empower innovation. The RESOMER® Precise platform leverages a unique process technology that enables the process validation of custom polymers to extremely tight product specifications. Other specialized polymer options include RESOMER® Zero, with ultra-low tin content to address specific application or administration requirements, and RESOMER® Sterile, the world’s first sterile extended release PLGA excipient.
Extensive expertise in pharmaceutical biomaterials: APIs, excipients, formulations and applications
Evonik combines extensive expertise across APIs, pharmaceutical biomaterials, formulations and applications to optimize the safety, efficacy and performance of your parenteral drug products. In addition to systemic delivery, we also have broad application expertise across a range of localized delivery areas including ocular delivery, joints delivery, brain delivery and sinus delivery. Speak with our pharmaceutical biomaterial experts about topics including hydrophilic vs hydrophobic drug product requirements, terminal sterilization and aseptic manufacturing techniques and functionality optimization for extended release or targeting. We can also help to find the right balance between drug potency, administration volume, and duration of drug release based upon the drug’s physical and chemical properties, the use of particular process technologies and the interaction between the API and selected excipient.
CMO services for pharmaceutical biomaterials and functional excipients
Evonik is leveraging more than 60 years of market leadership in functional excipients to serve as a custom manufacturing (CMO) partner to companies seeking to outsource the production of their own proprietary products. A range of CMO services for pharmaceutical biomaterials are available for the synthesis and purification of polymers from pilot scale to large-scale commercial batches at our cGMP sites in Germany and the USA. Additional areas of project support include access to our development labs and process engineering teams to support the development, optimization and scale-up, and the provision of core data for regulatory submissions. These services are available for a wide range of polymerization platforms including bulk polymerization, solutions, emulsions and suspensions.