Parenteral drug products continue to become more specialized and personalized with today’s new modalities. To ensure these drug products, including drug delivery products, are designed to be as safe, efficacious and reproducible as possible for clinical and commercial use, it is important to collaborate with a contract development and manufacturing organization (CDMO) with the right formulation development and technology expertise early in the drug development process. Evonik has been a leading global CDMO in the formulation development and process development of polymeric and lipid-based drug products for more than 40 years. Our strong mix of core competencies across a range of drug delivery and product-by process technologies give us the versatility as a CDMO to explore multiple formulation development pathways to determine the best approach based upon your specific API, product profile and administration requirements.

As a leading global CDMO, our formulation development services can play a vital role in helping pharmaceutical and biotech companies develop a range of human and animal drug products, including those with highly potent APIs and controlled substances (III-V). We also have extensive expertise across a range of drug substances including small molecules, nucleic acids (mRNA, siRNA, oligonucleotides), proteins and peptides, antibodies and vaccines, and administration routes including intramuscular, intravenous, subcutaneous, intravitreal and intradermal, as well as local delivery. Our CDMO services for formulation development have helped customers to enable, enhance and differentiate their parenteral drug products across a range of therapeutic areas including oncology, rare diseases, ophthalmology, CNS and orthopedics.

A range of CDMO formulation development services are available during the R&D and pre-clinical stages including feasibility studies to design prototype formulations for in vivo screening, developmental stability studies, process identification development studies, the selection of a lead formulation candidate, and the preparation of test articles for IND-enabling toxicology and stability studies. During human clinical trials, a range of additional contract development and manufacturing organization services can be conducted including formulation optimization and lifecycle management strategies, process optimization and scale-up, process performance qualification (PPQ), technology transfer and scale-up, and cGMP production and filling. Throughout the entire process, we utilize a development-stage appropriate Quality by Design (QbD) approach, together with process characterization principles, to identify and control critical process parameters that can be applied across the development, scale-up and optimization of the drug product manufacturing process.

In addition to CDMO formulation development projects relating to extended-release drug products for systemic delivery, we also specialize in localized drug delivery including for the eye, joints, tumors or the spine. Additional formulation outcomes that we routinely provide to customers include gene and disease-site targeting, improving drug uptake at the target site, enhancing solubility and bioavailability, reducing dose volume or needle size, increasing efficacy, enabling targeted drug delivery and distribution, and decreasing the risk of side effects for improved safety. In addition to benefiting from the outcomes in formulation development we can deliver as a contract development and manufacturing organization, customers can also leverage our market-leadership in the design, development and customization of RESOMER® bioresorbable polymers to ensure your selected excipient is perfectly matched to the API and target release profile.