Process Analytical Technology (PAT) devices are essentially analyzers that can measure physical and chemical process parameters as well as important attributes to optimize process control.
PAT probes and sensors are designed to enhance the understanding of bioprocesses, aiming to ensure quality and consistency at every stage of product manufacturing. These tools play a key role in achieving Quality by Design (QbD) principles and enabling real-time release. This webinar will explore their advantages, challenges, and potential future developments.
About the speakers
Marina Kirkitadze is the Head of Process Support and PAT Platform at Analytical Sciences North America, Sanofi. She has 20 years of expertise in the vaccination sector.
Kirkitadze earned her Ph.D. in Biological Sciences from the Institute of Protein Research, Russian Academy of Sciences, Pushchino, Russia, and her MBA from the University of Phoenix, Arizona, US.
Kirkitadze was a postdoctoral associate in the Department of Chemistry at the University of Edinburgh before joining Sanofi. She also worked at the Center for Neurological Diseases at Brigham and Women's Hospital and Harvard Medical School.
Kirkitadze’s primary focus is on the design and implementation of PAT systems for in-line monitoring of media components, protein concentration and shape, process residuals, and protein adsorption.
Her contributions included the CMC part of the eBLA application for Adacel, approval for the new manufacturing plant and its extension, Pentacel, and the Module 3 CTD of the Hexaxim vaccine submission. Marina has published 42 manuscripts.
Gabriella Gerzon is a Ph.D. student in the Biology Department at York University in Toronto, Canada. Gerzon got her MSc. in Biological Sciences from York University, where she studied epigenetic signaling systems in response to DNA damage.
Gerzon’s current study, conducted in conjunction with Sanofi Pasteur Ltd., focuses on developing new analytical techniques for implementing PAT solutions in bioprocess monitoring.
Gadsby graduated from the University of Bath in the late 1970s, and after working in several industries, he was appointed as Kraft Foods' European R&D Process and Process Automation Group Leader.
After a few years at Kraft, Gadsby decided to start a process automation company with a colleague, Dave Richards, and Optimal was formed.
Optimal Industrial Automation was founded over 33 years ago, and Gadsby is now Vice President of Optimal Industrial Technologies, which was formed more recently as the products division and is the market leader in Process Analytical Technology (PAT) with its PAT Knowledge Management product, synTQ.
Gadsby is actively involved in the advancement of synTQ and advises the Optimal development team on what he feels to be the best development path.
Over the last few years, he has taken over general responsibility not only for the company, but also for synTQ's sales and marketing, while being actively involved in ensuring synTQ's continued development. Gadsby is a 'petrolhead' who enjoys flying aerobatics and racing vehicles.