Conference Day Two

8:45 am Morning Coffee

9:15 am Chair’s Opening Remarks

Enhancing Data Integrity & Lifecycle Management for Streamlined Manufacturing

9:30 am Overcoming the technical challenges related to real time release in an appropriate quality framework

  • Mathieu Bibian Senior Manager Analytical Research and Development, GSK


  • Presentation of a case study for the replacement of offline in-process QC test by online testing and the subsequent adaptations to our quality framework in support of real time release.
  • Incorporating real time release into a digitalized manufacturing process

10:00 am DeltaV™ Spectral PAT – Real-Time Monitoring & Control for Process Analytical Technologies

  • Bruce Greenwald DeltaV Platform Business Development Sales Director, Emerson Automation Solutions


  • Simplifying the architecture and workflow from off-line model development to real-time model deployment for use in real-process control
  • Advances that enable a simplified workflow and robust architecture to quickly deploy multivariate models online for monitoring and control while easily maintaining their performance over time
  • Implementing this transformative technology across a pharmaceutical production enterprise

10:30 am Morning Break & Networking Poster Session

Innovation in PAT for Cell & Gene Therapy to Overcome Development & Manufacturing Bottlenecks

11:30 am Utilizing Process Analytical Technology (PAT) for Identification of Critical Process Parameters (CPPs) & Critical Quality Attributes (CQAs) in the Field of Cell Gene Therapy

  • Sarah Rajani Scientist, Process Analytical Technologies, Bristol Myers Squibb


  • Real-time monitoring and control through PAT to detect the impact of CPPs on product quality, leading to reduced cycle times, improved resource utilization, and cost savings
  • Exploration of PAT and new tools within the field of cell gene therapy, enabling faster analysis of personalized therapies and accelerating the speed to market

12:00 pm Revolutionizing Gene Therapy Manufacturing with Real-Time Release & Innovative PAT Solutions to Increase Production Output & Reduce Production Time


  • Implementing cutting-edge biotechnology tools to ensure accuracy and reliability of data in real-time release strategies for gene therapy manufacturing
  • Developing high-throughput machines and leveraging PAT to significantly reduce production time and increase output in the cell and gene therapy space

12:30 pm Online Monitoring of C&GT Bioprocess with Microscopy


  • Examining real-time monitoring of VCD for process & manufacturing control
  • Leveraging closed-loop process control for CART manufacture
  • Beyond VCD: infection kinetics of SF9, VCD of cells on microcarriers

12:40 pm Networking Lunch

Advancing Modeling & PAT Integration for Seamless Development & Manufacturing

1:40 pm Round Table: Using Machine Learning to Improve Data Handling, Increase Data & Enhance Model Performance


  • Rethinking data management between PAT equipment with AI to achieve data integration and real-time data synchronization.
  • How to increase robustness of data sets with augmented data sets to improve model performance and reliability.
  • Addressing regulatory requirements and compliance in machine learning and PAT implementation for GMP environments

2:35 pm Increasing Efficiency On the Journey Towards Semi-Continuous Processes & Improved Real-Time Monitoring Through PAT Technology Implementation


  • PAT implementation as the way to semi-continuous process implementation versus batch processing
  • Streamlining data from multiple continuous processes for increased coherency and resource optimization
  • Replacing traditional off-line QC with in-line PAT and real-time measurements to increase production efficiency

3:05 pm Roundtable: Where is Everyone’s Baseline?

  • Sarah Rajani Scientist, Process Analytical Technologies, Bristol Myers Squibb


  • Discussing the available tools and measurements in PAT for cell and gene therapy development and manufacturing
  • Comparing system and method development systems to establish a baseline for implementing PAT in the field
  • Determining the shortest manufacturing turnaround time achieved with PAT whilst maintaining data integrity and product quality, to improve data-driven decision making and adaptive process control

3:50 pm Chair’s Closing Remarks

4:00 pm End of Summit