Investigational and discovery phase APIs: When to consider solid state science

You have identified and selected the structure of your compound from medicinal chemistry investigations as a therapeutic agent and is a new chemical entity, NCE, and have also generated material with which you are collecting pharmacokinetic and toxicological information to support your drug compound.

Amongst the many items to deal with is the availability of drug substance for further investigations and development. Whilst refinement of the chemical processes might require attention, the physical nature of the API has to be brought into the spotlight, not only from the formulation development perspective, but also as part of the final drug substance isolation process operation.

This is the world of solid state science and crystallisation development. This is where biopharmaceutical and innovator drug discovery organisations require guidance to progress their asset into development in order to demonstrate safety and clinical efficacy. This should be taken forward rationally and efficiently since, as we all know, time is money.

Whilst pharmaceutical organisations are often leading the development of new approaches and techniques for drug substances and products to improve scientific knowledge in order to reduce the time to gaining regulatory approval for a therapeutic area, their investigational API and development programmes can be complemented by drawing upon additional resources.

At MorphCryst Consulting, we can assist the small and the established with their solid state science and crystallisation activities since they are paramount to the success of your drug substance.