Crystallization Development – From Solid Form Screening to a GMP Crystallization Process

The aim of a crystallization process is to produce the optimal solid form with all desired properties such as particle size, particle shape, bulk density, purity, yield, residual solvent content, etc. In order to reach this goal, many steps need to precede the crystallization development.

In a salt and/or co-crystal screening and characterization, the optimal salt or co-crystal has to be identified. This is followed by a polymorph and solvate screening of the corresponding substance where all relevant forms are identified, characterized and their thermodynamic relationships are determined. Very often either the thermodynamically stable form at room temperature or a hydrate is selected. Knowledge of critical water activities for hydrate formation and kinetics of hydration and dehydration is therefore essential.

After selecting the optimal form, a small scale (10mL to 250mL) crystallization process – using state-of-the-art equipment such as Lasentec probes – is developed in order to obtain the selected form with the desired particle size distribution and purity, while optimizing yield, speed, etc. Very often a seeded crystallization process is required in order to achieve optimal control. This process is then further scaled up in a kilo-lab, followed by production on a kg-scale in a GMP facility.

Join this webinar to learn about crystallization development and how quick communication and efficient know-how transfer between the scientists of the various disciplines assures a very efficient and fast process.

Speaker

Rolf Hilfiker, PhD, Vice President, Head of Department Solid-State Development, Solvias

Rolf Hilfiker is Head of the Department of Solid-State Development at Solvias. Solvias is a scientific services company focused on leveraging expertise in various scientific disciplines to accelerate the drug discovery and development process. The department of some 20 people does contract research and development in the solid-state area, i.e. polymorphism studies, salt and co-crystal screening and selection, method development, crystallization optimization, etc.

Rolf obtained his Ph.D in physical chemistry from the University of Basel, Switzerland. From 1987-89 he was a Post Doc at SUNY, New York and from 1989-1992 a Senior Research Fellow at the University of Basel. He has more than twenty years of experience in an industrial R&D environment at Ciba-Geigy, Novartis, and Solvias. Under his guidance, Solvias became one of the leading solid-state service providers in the world.

He has authored more than 60 scientific publications as well as numerous patents in various areas of physical chemistry and editor of “Polymorphism – In the Pharmaceutical Industry,” Wiley-VCH, 2006.

Message Presenter