Control Polymorph Particle Size and Purity Through Crystal Engineering
The Importance of Controlled Crystallization Processes and the Impact on the Polymorph, Particle Size and Purity of APIs
Program Overview
- Optimization of APIs isolation through controlled crystallization processes
- Polymorphism and the impact on solid stability
Many active pharmaceutical ingredients (APIs) possess more than one morphology and polymorph. Different process conditions can result in solid forms with drastically different physical properties. Generally, solid materials are preferred over liquid in multi-hundred-kilogram scale processes in pharmaceutical industry due to better stability and handling. In this presentation, we demonstrate a chemical conversion of a pharmaceutical intermediate from oil to solid form and the techniques to optimize the process chemistry, crystallization, and how these enhance the stability of the compound. In a second example, we demonstrate how controlled crystallization not only helps to optimize the physical properties of an API but also the impact on the purity profile.
Presenters
Bahareh Khalili, Ph.D.
Manager, Solid State Research & Development, Eurofins CDMO Alphora Inc.
Dr. Bahareh Khalili obtained her Master of Science and Ph.D. in Organometallic and Solid State Chemistry from University of Western Ontario with studies focused on the synthesis and characterization of novel metal phosphide and chalcogenide nanoclusters. She furthered her academic studies on Solid State for pharmaceuticals during her post-doctoral fellowship in Dr. Sohrab Rohani laboratory at University of Western Ontario. Bahareh started her industrial career by joining the Research and Technology department of Apotex Pharmachem Inc. with emphasis on advanced solid state challenges in pharmaceutical industry. Since joining Eurofins CDMO Alphora in 2018, Bahareh has been leading the Solid State Research & Development business unit and a group of solid state scientists utilizing state-of-the-art instrumentation in assisting API and drug product development programs at different lifecycle stages. Bahareh’s Solid State Research & Development team efforts include fast high-throughput screening for discovery of polymorphs, salts and co-crystals, full physicochemical characterization of APIs and crystallization process development. Bahareh has 15 articles published in peer reviewed journals as well as 12 patent applications filed in different countries.
Peter Ho, Ph.D.
Senior Research Scientist, Eurofins CDMO Alphora Inc.
Peter Ho received his B.Sc. degree in Honours Chemistry CO-OP from McMaster University. He then continued to graduate studies in the group of Professor Vargas-Baca at McMaster. His thesis project, entitled “Te…O Chalcogen Bonding in Supramolecular Chemistry”, involved the investigation of supramolecular chemistry of iso-chalcogenazole N-oxides and related compounds to augment our knowledge of chalcogen bonding. In 2022, he received the Governor General’s Academic Gold Medal for his Ph.D. work. Currently, he is a Senior Research Scientist at Eurofins CDMO Alphora Inc. whose work is focused on the solid-state research and development of active pharmaceutical ingredients (APIs). He is keen to apply crystal engineering concepts to improve physical properties and stability of APIs that could potentially lead to the production of better drug molecules.
