SIFT-MS: Real-Time Volatiles Analysis for Continuous Manufacturing of Pharmaceuticals

Register to learn how real-time SIFT-MS analysis can revolutionize the analysis of pharmaceutical volatile impurities in continuous manufacturing. Understand how SIFT-MS is readily integrated with manufacturing equipment, enabling better process optimization and rapid decision making.

Register Free: https://www.chromatographyonline.com/lcgc/volatiles

Event Overview.

The pharmaceutical industry has traditionally favored batch manufacturing driven by process complexity and relatively small scale of operation compared to the rest of the chemical sector. However, the industry is facing significant change as demands from patients, payers, and healthcare systems drive increased complexity in the design, development, manufacturing, and supply of future medicines. One way this is being addressed is through a shift to continuous manufacturing to increase consistency, reduce operating costs, and implement advanced process control based on real-time measurements.

Selected ion flow tube mass spectrometry (SIFT-MS) is a direct-injection mass spectrometry technique that addresses the needs of continuous manufacturing through real-time, broad-spectrum, high-sensitivity analysis that can be validated according to conventional pharmaceutical industry guidelines. This webinar demonstrates application of real-time SIFT-MS analysis to:

• Determine solvent-drying endpoints in state-of-the-art active pharmaceutical ingredient (API) drying systems.
• Enhance speciation and quantitation of volatile degradation products—including acetic acid, acetic anhydride, and butenal—during thermogravimetric analysis (TGA).
• Identify and quantitate trace volatile impurities during hot-melt extrusion of oral dose formulations.

Join to learn how SIFT-MS is simply faster.

Key Learning Objectives:

• Understand the fundamental features of SIFT-MS compared to conventional GC-MS, including its ability to analyze samples in real time with high specificity.
• Through case studies, understand how readily SIFT-MS instrumentation is integrated with continuous manufacturing equipment.
• Learn how SIFT-MS provides immediate feedback on trace volatile compounds in pharmaceutical products from residual solvents to impurities formed in-process through thermal degradation.

Who Should Attend:

• QA/QC managers, scientists, and engineers
• R&D engineers and scientists
• Laboratory managers/directors/supervisors
• Analytical chemists
• Production scientists and engineers
• API manufacturers
• Formulation specialists
• Excipient manufacturers
• Consumer safety scientists

Speakers:

Professor Chris Price, PhD, FRSC, CChem
Professor of Industrial Crystallization & Isolation
Department of Chemical & Process Engineering

Chris Price is Professor of Industrial Crystallization & Isolation based in the Department of Chemical & Process Engineering at the University of Strathclyde. His research focuses on the continuous crystallization and isolation (filtration, washing, and drying) of pharmaceutical materials and increasing sustainability in pharmaceutical manufacturing by minimizing solvent use. He has been active in industrial crystallization for over 30 years, mostly in the pharmaceutical industry. Prior to joining the university staff as a manufacturing fellow, he spent 14 years with GSK. As a senior scientific leader at GSK, he was responsible for technology and innovation at the drug substance and drug product interface. Chris also teaches short courses for industry in crystallization and isolation and in process safety.

Aaron Smith
PhD Researcher
CMAC Future Manufacturing Research Hub

Aaron Smith is a PhD researcher with a background in chemistry, having a strong interest in organic and analytical chemistry. Aaron is part of the larger CMAC project known as the Digital Design and Manufacture of Amorphous Pharmaceuticals (DDMAP) where he belongs to Work Package 2. This concerns the manufacture of amorphous solid dispersions via hot-melt extrusion (HMA) and developing advanced characterization methods to ensure their success.

Mark Perkins, PhD
Senior Applications Chemist & SIFT-MS Specialist
Element Materials Technology

Mark Perkins is a senior applications chemist at Element Materials Technology Laboratory Instrumentation in Cambridge, United Kingdom (formerly Anatune) and a global authority in automated SIFT-MS. Mark has extensive experience in both conventional chromatographic methods as well as SIFT-MS. Prior to joining Anatune in 2015, he spent 12 years as a senior analyst and chromatography section manager at the Malaysian Rubber Board’s UK research center working on regulated pharmaceutical applications within a GMP environment.

Register Free: https://www.chromatographyonline.com/lcgc/volatiles