The Latest on Digitalization, Process Analytical Technology and Quality Control

WEBINAR

The Latest on Digitalization, Process Analytical Technology and Quality Control

Webinar Overview

Advanced manufacturing technologies (AMTs) can speed drug development, improve quality and minimize drug shortages. Consequently, the FDA encourages early adoption of these technologies.

This webinar will explore how digital transformation enhances the efficiency, accuracy, and reliability of process analytical technology (PAT) and quality control systems. We will present the principles and applications of PAT highlighting the importance of real-time monitoring and high-fidelity control of production processes. Attendees will gain insights into the latest digital tools in quality assurance and process control, ensuring compliance with regulatory standards and improving overall product quality. They will learn how PAT and associated technologies improve knowledge transfer and propagate accessibility from R&D to full-scale production. Join us to discover how these advances are shaping the future of late development and advanced manufacturing and learn practical strategies for implementing these technologies in your operations.

Session 1: 11:00 a.m.

Enabling Digitalization from R&D to Manufacturing - AI Ready Data through Ingestion & Standardization

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Session 2: 11:25 a.m.

How vibrational spectroscopy helps to accelerate new drug development and troubleshoot drug production

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Session 3: 11:50 a.m.

The Benefits of Raman Spectroscopy for the Understanding and Control of Pharmaceutical Processes

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Session 4: 12:15 p.m.

Advancing Continuous Process Monitoring and Optimization with Benchtop NMR in PAT

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November 20, 2024 | 11:00 a.m. EST

Key Learning Objectives

Become familiar with available PAT spectroscopic tools such as NMR, NIR, mid-IR and Raman as well as their key applications that can enhance process control and quality control goals.
How to deploy spectroscopic and digital tools in a way that will advance PAT objectives.
Gain awareness about the way that many companies have already made use of PAT strategies that have proven to be beneficial.

Who Should Attend

Laboratory managers
Chromatographers
New product developers

Speakers

Dr. Sergey Shilov
North America Product Manager, Science Business Unit, Bruker Optics

Dr. Sergey V. Shilov is a Product Manager for North America at Bruker Optics. Sergey joined Bruker in 2001. He is responsible for the support and development of new applications for the Bruker research FTIR systems. He received his Ph.D. in 1992 from the Russian Academy of Sciences in Polymer Physics and his M.S. from St. Petersburg State University (Russia) in Physics in 1986. Alexander Von Humboldt Foundation (Germany) awarded him a research fellowship in 1996. Sergey published 37 papers in peer-reviewed journals. His research interests include time-resolved FTIR spectroscopy, surface science, polymer, and life-science applications.

Anna Codina, Ph.D.

Senior Director Strategy and Business Development, SciY

Anna has a degree in Chemistry and a Ph.D. in Protein NMR from the University of Barcelona, Spain. She undertook her post-doc in protein NMR at the MRC Laboratory of Molecular Biology in Cambridge, UK, and following that worked in the Analytical R&D department of Pfizer for seven years, becoming proficient in low level impurity structure elucidation, reaction monitoring, qNMR and the preparation of regulatory documentation. She received a Pfizer Worldwide Achievement Award for the implementation of reaction monitoring by NMR in an open access environment.

She joined Bruker in 2011 and had different roles since including Material Characterisation Laboratory Manager, Product Portfolio Manager and for several years was in charge of driving the Biopharmaceutical business at Bruker BioSpin. Anna recently moved to SciY as Senior Director of Strategy and Business Development.

Mark Kemper
Associate Director, Business Development, Tornado Spectral Systems

Mark Kemper is Associate Director of Business Development for Tornado Spectral Systems, a Bruker Company. His undergraduate and graduate degrees are in Chemistry from the University of Dayton and the University of Minnesota, respectively. Mark worked in the pharmaceutical industry for nine years as an Analytical Chemist before moving to the instrumentation industry, where he has worked for the past 30 years. During this time, he has mainly been involved with Raman, near infrared, FT-IR, terahertz and NMR technologies. Most of the last 20 years has been focused on Raman spectroscopy.

Matteo Pennestri, Ph. D.

Team Leader, PAT and Automation, Pharma Business Unit Bruker BioSpin

Matteo Pennestri obtained his Ph.D. in Biophysical methods at the University of Tor Vergata Rome (collaboration with Merck Sharp and Dohme). Then he moved as NMR spectroscopist in the pharmaceutical industry (MSD and EISAI). After experiencing the pharma sector, he joined as application scientist Agilent Technologies first (ex. Varian) and Bruker afterwards. After joining the Bruker Pharma unit as NMR specialist and Product Manager he recently become Team Leader PAT for Automation and Process Analytical Technology.