Continuous Bioprocessing: PAT Strategies in Support of Process Monitoring and Control to Enable Rapid Product Release

Continuous bioprocessing offers potential to enhance productivity and product quality uniformity while simultaneously decreasing facility footprint and associated operational overhead. Advances in technology and increasing commercial pressures are leading to an increased interest in continuous processing across the biopharmaceutical sector. A number of companies are exploring and advancing continuous bioprocessing and this presents a range of opportunity and challenges, including the use of Process Analytical Technology (PAT) for process characterization, process control, and process robustness, in support of a Rapid Product Release (RPR) strategy.
 
Presentation by Jeff Doyle & Dr Paul Jeffers
Jeff supports the delivery of innovative Process Analytical Technology (PAT) at Pfizer’s mAb and Vaccine launch sites through his role as Manager, PAT Projects in the Process Analytical Sciences Group.  He’s active in industry technology road mapping and previously held positions in Technical Services and Validation.  Jeff holds a BS in Chemical Engineering from Clarkson University.
 
 
 
Paul is Manager PAT Projects in Process Analytical Sciences Group, Global Technology Services, Pfizer Global Supply. He supports the development and implementation of PAT technologies and approaches to support bioprocess development and commercial manufacturing.  Paul has a BSc. In Biotechnology from Dublin City University and a Ph.D. in Chemical Engineering from University College Dublin, Ireland.
 
 
 

 

 
MKS Data Analytics Solutions are leading data analytics experts with multiple applications in high-tech industries worldwide. We enable customers at both the individual and enterprise levels to maximize the value of their data, enabling better decision-making and process excellence. Through our complete solutions in the Umetrics™ Suite of Data Analytics Solutions, which include state of the art software, academy training and education, consulting, and OEM services, we help our customers to grow their businesses by maximizing profitability and minimizing time to market. To learn more about how MKS Data Analytics Solutions helps you grow your business please visit www.mksdataanalytics.com and follow us on LinkedIn.
 
Presented by Jonas Elfving, MSc
Jonas delivers new innovative solutions continuously to the manufacturing industries as product manager for the Umetrics™ Suite of data analytics solutions at MKS Instruments. For over 15 years he has been in the center of cutting edge analytics applied to bioprocessing. As product manager he has close contacts with the PAT teams in most top bio-pharma companies to be able to provide the right solutions for bio pharma engineering. Jonas holds a MSc in Applied Physics and Electrical Engineering from Linköping school of Technology in Sweden.
 
Presentation Title: Applying advanced analytics for inferential quality control on continuous processes
 
Presentation Summary: What’s the benefit to expand your regulatory control strategies to also include supervisory control? The benefits of using different advanced analytical tools for Process Analytical Technology (PAT) on bioprocessing can nowadays be applied to both batch and continuous processes. The analytics for the two different type of processes are more similar then one might think, and the same methods can be used both for hybrid and pure continuous processes as for batch. To reach Rapid Product Release, while allowing variation in the raw material and a process that changes is no longer an impossibility. It’s a reality.