Best-in-class services for the drug product development of oral solid dosage forms
With the Evonik team of polymer and oral formulation specialists by your side, you can expect reduced project complexity during any stage of drug product development from initial feasibility through to the clinical manufacturing, supply and transfer of the final dosage form. With a worldwide network of labs and decades of expertise across all oral solid dosage forms, process technologies and equipment, we can provide you with project teams that complement your specific API, drug product development and manufacturing requirements. In addition to our advanced technical knowledge regarding the production of excipients and the handling of high potency APIs as well as controlled substances for small molecules and biologics, we also have a strong track record in providing functionality solutions across a broad range of application areas.
Highly specialized drug product development capabilities
As a preferred solutions provider and drug product development partner, we make use of our long-standing experience and research in the fields of polymers, formulations and finished drug products. We have helped pharmaceutical and biotechnology companies bring to market a range of drug products in complex oral dosage forms including small molecules, peptides, enzymes, nucleic acids and those with high potency APIs and controlled substances. Specialized areas of expertise include personalized medicine and 3D printing, the development of pediatric or geriatric medicines, oncological, orphan and poorly soluble drugs, continuous manufacturing, microbiome delivery, and the oral administration of biologics.
A range of formulation and application services for drug product development
Our best-in-class teams can bring exceptional value to any oral drug product development or clinical manufacturing program. Prior to the development of your formulation, we can efficiently conduct a range of services including fast-track feasibility studies, an evaluation of functional polymer options, and a review of relevant processing and drug delivery technologies. A range of services are available to help you either develop a new formulation or reformulate an existing one, including technology matching to your target release profile and the supply of prototypes for pharmacokinetic and stability studies. Process and analytical method development services may also predict and accelerate the path to clinic and launch. During each step in the drug product development process, Quality-by-Design (QbD) principles are rigorously followed to additionally reduce project risk.
Fast, flexible and reliable clinical supply and scale-up support for drug product development
We provide advanced contract services for the clinical trial manufacturing of complex oral solid dosage forms. By combining our global network of labs with fully equipped and licensed cGMP manufacturing facilities in Germany, you can leverage our speed and flexibility to receive phase I or II clinical batches within just a few months to anywhere in the world.
Dosage forms where we have a strong history of manufacturing excellence include capsules filled with pellets, mini-tablets or solid dispersions; pre-coated capsules filled with a liquid; 3D-printed multi-compartment tablets; multiparticulates and matrix tablets. Complementary clinical manufacturing services include packaging and labeling, quality control, and referrals to qualified CMO partners for clinical and commercial scale-up in your preferred country or region.
Regulatory support and local market expertise to reduce drug product development risk
In addition to our pharmacopeial monographs for EUDRAGIT® polymers being widely accepted across key global regions including the U.S., Europe, Japan and China, you can leverage our regulatory expertise across a range of local markets. Robust documentation is available to support the filing of your NDAs and marketing authorizations including safety and toxicology packages, polymer specifications and letters of authorization for DMFs. Detailed statements regarding our polymers can also be provided for special purposes.
ORAL DRUG PRODUCT DEVELOPMENT SERVICES
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