Path to Smart Manufacturing and Intelligent Development within Industry 4.0 – Building an Integrated Sensing Strategy

Over the years there have been many frames of reference on the use of process analytical technology (PAT) in the commercial manufacturing space including monitoring, closed-loop control, quality control/real-time release, advanced process control, quality by design, Industry 4.0, etc.  With each evolution of framing, the context we view process sensing and analysis of manufacturing processes is trending towards expanded scope and context from unit operation to production train, plant level, and up through manufacturing network, supply chain and value chain to the customer. Similarly in the Development space, the frame of reference for the use of PAT continues to evolve as various capabilities become standard aspects of pharmaceutical and biopharmaceutical process technology stacks enabling the use of digital twins, modelling, and workflow automation which aim to drive more efficient and reliable development, technical transfer, and lifecycle management practices. In this talk, we will present how we at Biogen are integrating PAT as part of our Digital Evolution strategy on a pathway toward the realization of Smart Manufacturing and Intelligent Development.

Presented by Dan Hill, Associate Director, Digital Development & Analytics, Product & Technology Development at Biogen 

Dan Hill is the Associate Director for Process Analytical Technology in Biogen’s Product & Technology Development organization. He specializes in the development and commercialization of process analytical technology and is responsible for building and executing process measurement strategies that enable not only reliable process control but also advanced predictive capabilities. Dan is an accomplished cross-functional leader currently driving Digital Transformation and innovation investment programs across Biogen’s Development functions. Dan holds a B.S. in Biochemistry from Ball State University and an MBA in Strategic Innovation from North Carolina State University. Dan is inspired daily by his wife and their two daughters. In his free time, Dan enjoys running and weight lifting, hiking with his family, and exploring National Parks.

Chris McCready, Lead Data Scientist at Sartorius Stedim Biotech

Chris McCready is Principal Research Scientist with Sartorius Corporate Research with chemical engineering degrees from the University of Waterloo and McMaster University. Chris joined Umetrics in 2004, and Sartorius through acquisition more recently. Before joining Umetrics Chris worked in Oil & Gas with Petro-Canada and in fuel cell and integrated power systems with United Technologies implementing advanced process control strategies and providing dynamic simulation and systems design. Presently Chris is part of Sartorius Corporate Research managing the Biosimulation team in Advanced Data Analytics. The biosimulation team builds and tests modelling approaches for upstream and downstream unit operations for developing virtual twins and advanced control applications.

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 has 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 whilst remaining very active in ensuring that the development of synTQ continues unabated.  On the personal front, Martin is a bit of a ‘petrol head’ and enjoys flying aerobatics and racing cars
 
 Sponsored by Sartorius Stedim Data Analytics and Optimal Industrial Technologies Ltd

About Sartorius

Sartorius Stedim Data Analytics develops software under the Umetrics Suite for the design of experiments and multivariate data analysis, for the individual user as well as for online continuous and batch processes. The stability of Umetrics founding principles and the flexibility of our services enable us to promote every way of implementation of design of experiments and multivariate technology that our clients require. We are committed to supporting our clients in their mission to take control over their data flow, by conveying our advanced expertise in advanced data analytics technology. Our mission is to provide comprehensive solutions which create value from data, enabling better decision making and process excellence.

Our market exists in every sector of industry where there are manufacturing, testing or data analysis activities, but historically the highest number of collaborations has been in the life science, semiconductor and chemical industries. Umetrics is since April 2017 owned by Sartorius Stedim Biotech AS

 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 together with 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.