Applying Low Frequency Raman to QbD in Pharmaceutical Development

26th April 2019 | 10.00 am EST | John Wasylyk, Senior Principal Scientist at Bristol-Myers Squibb Company and James Carriere, Product Line Manager for Coherent’s THz-Raman product line |WATCH FOR FREE

Low frequency Raman spectroscopy has been used to study various polymorphs and can be applied to the design of crystallization control strategy. Extending the low frequency spectral region to include the fingerprint region provides access to collective vibrations of molecules in the amorphous and crystalline states and yields valuable insight when differentiation of various forms is quintessential. Whether during process development or production, low frequency Raman bands provide greater sensitivity for detecting the onset of crystallization and has allowed differentiation of crystal types when multiple forms are possible. Applying this to Quality by Design (QbD) studies brings an increase in process understanding leading to developing optimal control strategy and avoid the many pitfalls that can occur when scaled-up to the production environment. A recent applications of in-line crystallization processes provided insight into establishing the ideal crystallization control parameters. The parameters evaluated include temperature, mixing rate, seed levels and solvent variable. In-line and off-line QbD studies demonstrated both ideal and non-ideal conditions, ultimately yielding critical process knowledge. As a result of our studies, low frequency Raman has proven to be a valuable tool for at-line and on-line monitoring of active pharmaceutical ingredient crystallization, and paves the way for robust production in a large scale facility.

Presented John Wasylyk, Senior Principal Scientist at Bristol-Myers Squibb

John Wasylyk, Ph.D. is a Senior Principal Scientist at Bristol-Myers Squibb Company.  He leads a vibrational spectroscopy group who are focused on developing non-invasive, sustainable methods designed to enhance productivity and generate process knowledge.  The spectroscopy-based methods have been deployed in areas ranging from early scale-up to manufacturing environments at various BMS sites.   The developed methods encompass both small molecules and biologics.  In addition, the group provides hands-on training and oversees open-access spectrometers for chemists and engineers.  John is currently the Marketing Chair for the Federation of Analytical Chemistry and Spectroscopy Societies (FACSS), and Pharmaceutical and Biopharmaceutical Section Co-Chair for SciX 2019.

Sponsored by Coherent

Coherent (formerly Ondax) is the market leader and only manufacturer of high-performance low-frequency THz-Raman® (Low-wavenumber) Spectroscopy Systems for a wide range of pharmaceutical, industrial, and scientific applications. THz-Raman® systems enable real-time, non-destructive, online/inline analysis of materials with enhanced sensitivity and information related to the physical chemistry of substances. The pharmaceutical industry is adopting this for real-time monitoring of formulation methods, polymorphs, and crystallization processes. The instrumentation is compatible with installed-base spectroscopy instruments and is compact and robust, adaptable to field use.

Coherent Inc. was founded in 1966, and is one of the world’s leading providers of lasers and laser-based technology for scientific, commercial and industrial customers.

Followed by James Carriere, Product Line Manager for Coherent’s THz-Raman® product line

James Carriere is currently the Product Line Manager for Coherent’s THz-Raman® product line. He has spent the last 8 years as Director of Business Development at Ondax, where he focused on developing the THz-Raman application space and building the THz-Raman® product platform that has gained wide adoption within the pharmaceutical industry. His responsibilities ranged from guiding the product design and applications development to sales and marketing, and the establishment and management of global distribution and OEM partnerships. He has a BSc in Physics from McGill University and a MS and Ph.D. in Optical Sciences from The University of Arizona.

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