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Category : 2022 Abstracts

Spherical Cocrystallization of Pharmaceuticals

By Prof. Changquan Calvin Sun, Pharmaceutical Materials Science and Engineering Laboratory, University of Minnesota The development of a quality tablet product requires overcoming deficiencies in pharmaceutical properties of an...

Five Degrees of Separation: Characterization and Temperature Stability Profiles for the Polymorphs of PD-0118057 (Molecule XXIII)

By Mr. Brian Samas, Pfizer Molecule XXIII is the most experimentally characterized crystal structure prediction (CSP) blind test molecule to date. Crystal structures of five polymorphs are presented with...

Amorphous or Crystalline? Using Next Generation PAT to Track API Particle Attributes for Enhanced Downstream Processability

By Richard Becker, BlazeMetrics   Process Analytical Technology (PAT) has dramatically expanded its capabilities over the last decade. Today’s PAT enables an in-depth understanding of process behavior on both...

Particle engineering by spray drying: process dev., scale-up, and technology transfer

By Dr. Nima Yazdanpanah, Procegence Drug substance isolation by crystallization and filtration and spray drying are last stages of the drug substance manufacturing process, where critical quality attributes (CQAs)...

Intelligent Cloud-Based Algorithms for Reducing Risk in Crystallization Process Development

By Dr. Mike Bellucci, XtalPi Inc   Crystallization is the most widely used separation and purification process in the pharmaceutical industry.  The resulting crystal structure and corresponding crystal morphology...

A Digital Mechanistic Workflow for Predicting Solvent-Mediated Crystal Morphology

By Prof. Kevin Roberts, University Of Leeds   The crystallization of organic materials provides a common, energy efficient methodology for the purification and isolation of high value compounds such...

Simulation aided solvent selection for robust impurity rejection by crystallization

By Dr. Yuriy Abramov, Exe. Director of CC&DS, J-Star Research Regulatory expectations for control of impurities in new drugs have been established through ICH guidelines. The most efficient approach...

A new approach to stere-opure atropisomeric molecules enabled by continuous flow-crystallization

By Dr. Michal Achmatowicz, Mirati Therapeutics Abstract: A new approach to stereopure atropisomeric molecules is enabled by a continuous flow-crystallization process. Continuous accumulation of the product under its optimal...

Combined In-Silico & Experimental Approach for Solid Form Screen & Selection

By Drs. Yuriy Abramov and Shanming Kuang, Center for Pharma Crystallization, J-Star Research Small molecule drug candidates tend to have different solid forms, including anhydrate, hydrate, solvate, salt, cocrystal...

Simulation Aided Process/Product Development, Scale-up, Tech-Transfer, and Regulatory Submission

By Dr. Nima Yazdanpanah, Consultant, Procegence Mechanistic modelling and process simulation, based on first-principle analysis, is a well-practiced tool in the chemical industry. The diverse applications have been enabled...

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