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Novel Optical Spectroscopy Approaches for Drug Product Development: Quality by Design

Apr 13, 2022
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ABOUT THIS WEBINAR
Optical measurements have been and continue to be essential for the development of pharmaceutical products. But the complexity and diversity of the drug development challenges faced today require significant innovation from instrument suppliers, pharmaceutical companies, and regulatory authorities. Gary McGeorge provides examples that demonstrate how process analytical technology (PAT) spectroscopic solutions have enabled more consistent formulations and manufacturing processes as part of a quality-by-design (QbD) practice. He also shows how applying PAT early can accelerate a development cycle. Looking ahead to future innovations, McGeorge provides a perspective on the opportunities that lie ahead for improvement and further implementation of pharmaceutical applications. PAT techniques have the potential to expand the scope of spectroscopy and how it can add value to the development, production, and distribution of medicines globally.

***This presentation premiered during the 2022 Photonics Spectra Spectroscopy Conference. For more information on Photonics Media conferences, visit events.photonics.com.  

About the presenter:
Gary McGeorgeGary McGeorge, Ph.D., is scientific director of drug product (DP) process analytical technology (PAT) at Bristol-Myers Squibb (BMS). He joined BMS in 1998, leading the spectroscopy group in materials science. He has been responsible for the analysis of polymorphs within solid pharmaceuticals, both as isolated components and formulated products. He has experience using a variety of spectroscopic tools, including infrared, near-infrared, Raman, and solid-state nuclear magnetic resonance (ssNMR). After moving to a DP process analytics group within BMS, McGeorge supported the design of DP manufacturing processes using PAT and, where appropriate, developed PAT control strategies for commercial manufacturing. Most notably, he designed Eliquis’ first real-time release testing (RTRT) program.

McGeorge’s research interests center around using spectroscopy to understand and characterize DP process dynamics and how they affect key attributes of downstream material — work that is ultimately linked to critical quality attributes (CQAs) of finished products. McGeorge has authored over 30 publications and is on the editorial advisory board of Spectroscopy magazine, the Journal of Pharmaceutical Sciences, and the Journal of Pharmaceutical Innovation.
spectroscopypharmaceuticalprocess analytical technology
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