Process Analytical Technologies – Advances in Bioprocess From Integration to Transition to Digital Manufacturing

Process Analytical Technology (PAT) instruments include analyzers capable of measuring physical and chemical process parameters and key attributes with the goal of optimizing process controls. PAT probes and sensors are intended for understanding bioprocesses to control quality and consistency at all stages of product manufacturing to achieve quality by design (QbD) and real-time release. The advantages, challenges, and future development will be discussed.

Presented by Marina Kirkitadze, Head of Process Support and PAT Platform, Analytical Sciences at Sanofi

Marina Kirkitadze is Head of Process Support and PAT Platform, Analytical Sciences North America, Sanofi.  She has 20 years of experience in the vaccine industry. Marina received her PhD in Biological Sciences at the Institute of Protein Research, Russian Academy of Sciences, Pushchino, Russia, and her MBA from the University of Phoenix, AZ, USA. Prior to joining Sanofi, Marina was a postdoctoral fellow at the Department of Chemistry, University of Edinburgh, and then at the Center for Neurological Diseases, Brigham and Women’s Hospital, and Harvard Medical School. Marina’s focus is on the development and implementation of PAT solutions for in-line monitoring of media components, protein concentration and conformation, process-related residuals, and protein adsorption. Her contributions went towards the CMC section in the eBLA application for Adacel, approvals for the new manufacturing facility and its extension, Pentacel, and Module 3 CTD of Hexaxim vaccine submission. Marina has published 42 manuscripts.

Followed by Gabriella Gerzon, PhD Candidate, York University, Toronto, Canada

Gabriella Gerzon is currently a PhD student in the Biology Department at York University., Toronto, Canada. Gabriella received her MSc. in Biological Sciences from York University, and her studies focused on mechanisms of epigenetic signalling in response to DNA damage. Currently, Gabriella’s research is in collaboration with Sanofi Pasteur Ltd. and focuses on the development of various analytical techniques to implement PAT solutions for bioprocess monitoring.

Followed by Martin Gadsby, Vice President, Optimal Industrial Technologies Ltd

Martin graduated from the University of Bath in the late 1970s, and after working through a few positions in the industry, he became the new European R&D Process and Process Automation Group Leader for Kraft Foods.  After a few years at Kraft, Martin decided to set up a process automation business with a colleague, Dave Richards, and Optimal was born. Optimal Industrial Automation was formed over 33 years ago, with Martin now being the Vice President of Optimal Industrial Technologies, which was formed more recently as the products division and is the market leader in the field of Process Analytical Technology (PAT) with its PAT Knowledge Management product – synTQ.  Martin is intimately involved with progressing the evolution of synTQ and advising the Optimal development team on what he believes to be the optimum development direction.  Over the last few years, he has taken on the overall responsibility not only for the company but also for the sales and marketing of synTQ while remaining very active in ensuring that the development of synTQ continues unabated.  On the personal front, Martin is a bit of a ‘petrolhead’ and enjoys flying aerobatics and racing cars

Sponsored by Optimal Industrial Technologies Ltd

About Optimal Industrial Technologies Ltd

Within the Optimal group, we have more than 30 years of experience in the automation and optimisation of control and data management systems for the pharmaceutical, biotech, and life science industries, with significant experience in both batch and continuous processing.  The demands being placed on manufacturers in relation to getting products to market sooner, minimising development and production costs, and increasing product quality and business sustainability are ever increasing; hence, the company’s primary aim is to deliver measurable improvements in all these target areas and has, through the years, developed many innovative solutions and approaches.

In addition to practical automation and system integration expertise, Optimal Industrial Technologies has also developed the world-leading PAT Knowledge Management software platform, synTQ® which is used by over 60% of the world’s leading pharmaceutical and biotech companies.  It has been a proven enabler of QbD via PAT by significantly increasing productivity and quality whilst reducing time to market, waste plus time to manufacture for batch and continuous processes.  It is being applied from the laboratory through to full GMP manufacture in small and large molecule drug substance and drug product processes and has assisted in cutting weeks from manufacturing times and in some cases, tripling production capability.