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Solvias AG

Solvias’ Seamless Approach for Development and Scale-up of Crystallization Processes

A well established multidisciplinary team covers the whole range from initial crystallization screening process to kg-scale production and final supply of material (GMP and non-GMP). These pooled expertise in solid-state development, crystallization process development, pilot plant production scale under GMP and non-GMP, supplemented with a state of the art instrumentation, enables Solvias to tackle the majority of drug development candidates. Crystallization processes are presently the most used techniques to purify a solid drug substance. Independent if chemical or chiral purity need to be enhanced, specially designed crystallization processes are the best choice for processing. In comparison to separation by chromatography, crystallization processes show in most of the cases also economic benefits. But not only purity aspects favour the use of crystallization techniques, also the controlled production of a desired polymorphic form, typically via seeding processes, can be achieved. In active pharmaceutical ingredients, several polymorphs and solvates may be present. A change of the crystalline form and/or the presence of an amorphous part may induce important changes concerning the physical properties like dissolution rate, bioavailability, stability or processability of the corresponding drug product. To get a robust and scalable process, a diligent investigation of significant parameters which could influence the crystalline form and its crystallinity is at utmost importance. “At Solvias a team of physico-, organic- and analytical-scientists work hand in hand to guarantee a seamless process development for the drug candidate without time and money consuming technology transfers” says Solvias’ Michael Becker, Product Manager for Solid State Development.

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