Removing chlorinated solvents from drug candidate manufacturing process

Purpose and goal:

The project aims to replace chlorinated solvents, which are unsuitable from both sustainability and health aspects, in a critical step in the manufacturing process of the active drug substance vipoglanstat. The step, which has proven problematic, is crucial in controlling the level of impurities in the final product and the process yield has a significant effect on how much chemicals and solvents are required in the previous manufacturing steps.

Expected results and effects:

The project is expected to lead to an increased understanding of how critical impurities are formed in the process and how they can be reduced. Likewise, the project will lead to an increased understanding of which parameters affect the crystallization and thus enable the development of a robust and efficient process in terms of both yield and quality without using chlorinated solvents as today.

Approach and implementation:

Relevant solvents in the current step will be screened on a small laboratory scale and form the basis for further development work and conceivable process alternatives. Critical impurities and their origins will be identified.

The development of an efficient process is a combination of reducing, if possible, the formation of impurities in earlier steps and applying the right parameters in the crystallization itself. Positive results will be tested and confirmed on a larger laboratory scale.