Appreciating the flair of polymeric materials in medical devices and pharmaceutical formulations
Mepodos Consulting is devoted to:
Developing the proper polymer for your device and formulation
Designing the dosage form for difficult to deliver substances
Technical support in your CMC processes
Enhancing the features of your new medical device
In striving for competitive advantages in a new medical device, unique functional features are required but difficult to obtain when using conventional materials.
Especially for high-value medical devices (often class IIb and III), such features may be enabled by modifying polymers into delicate formulations, by reprocessing, or by custom synthesis.
Mepodos can help clarifying how to obtain extraordinary features in your new medical device by modifying or synthesizing a new polymer, sourcing of such specialty polymers, and support your development process towards and beyond market approval.
Seeking ingenuity in pharmaceutical formulations
Most excipients used in pharmaceutical formulations are polymer-based, and a variety of specialized polymeric excipients are commercially available. However, in few cases even such polymers may be lacking the right performance, for instance where new delivery regimes are required for new drugs.
New polymeric formulations and drug carriers are emerging, and gradually being approved. Also, in the pipeline are polymers that by its own hold e.g., antiviral activity and hence are considered an API.
Mepodos can help developing new dosage forms, and should your formulation require customized polymeric excipients we can assist in narrowing down type and function and help sourcing.
Chemistry, Manufacturing and Control (CMC)
Prior to entering the stage of preclinical and clinical trials, and market approval, the manufacturing processes of a medical device and a pharmaceutical formulation must be properly designed and implemented to comply with applicable GLP/GMP requirements.
Mepodos can assist ensuring that new materials, formulations, synthesis and other related purification and isolation steps are fit for the purpose and are consistent from lot to lot. We have the proper QA/QE/QC competences available to contribute obtaining a robust processing layout and appropriate I/C’s, IPC’s, validation, and F/G control activities. Typical approaches applied are risk assessment and and QbD.
