Formulation research and development
A straightforward, science-based formulation development for (bio)pharmaceutical drugs is a key expertise of Coriolis Pharma. Formulation development service can start from scratch for molecules for which information on stability is not yet available. Moreover, specific formulation related questions, such as formulation optimization because of stability issues (aggregation, particle formation, chemical instability), re-formulation (e.g. change from liquid to lyophilized formulation, or vice versa), as well as primary-packaging questions are regularly addressed.
The developed formulations can be liquid, freeze-dried or spray-dried. Highly-concentrated protein formulations, including the related topics of high viscosity and special requirements during analytical characterization, belong also to our core expertise. Several of our formulations have successfully reached the respective clinical phases.
As service for our costumers we cover the following formulation spectrum:
- pre-formulation screening: including identifying suitable formulation composition (pH, ionic strength, protein concentration, excipients, ...); identifying degradation products; selecting stability-indicating methods; high throughput formulation approaches based on design of experiment are possible to reduce the required material and time
- pre-clinical formulation development: liquid, frozen or dried formulations (e.g. for tox-studies) are developed and can be produced under sterile conditions
- transfer of formulations to the external CMO of our customers choice (thereby being much more price competitive and flexible) including process transfer on site if desired
- formulations for late clinical development (phase III) and commercial application