Article | January 28, 2014

Drug Development: Take The Guesswork Out Of Crystallization

Source: Outsourced Pharma

In recent years, scientific complexity associated with developing small-molecule drug entities has steadily increased. Crystallization is a key process step required during the production of most active pharmaceutical ingredients (API) and their intermediates. Experienced engineers will agree that crystallization is an inherently challenging process operation — one that involves a blend of art and science — and even small variations in the process can have profound impact on the outcome for both the API producer and its business pharmaceutical partners, which incorporate the API into finished drug formulations.

At both R&D and commercial-scale production levels, crystallization is an essential step for synthesizing, purifying and separating target molecules. And during full-scale production of pure API, Today, the majority of small-molecule drug formulations rely on one or more API that are produced in a crystalline form. The ability to control crystallization is essential for ensuring that the final API product has both the desired crystalline form and the desired purity level.


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