Conference Day Two
8:15 am Morning Coffee
9:15 am Chair’s Opening Remarks
- Andreas Kunov-Kruse Senior Scientist, Analytical Technology in Manufacturing Development, Novo Nordisk Denmark
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 Associate Director, Analytical R&D, GSK
Synopsis
- 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 DeltaVTM Spectral PAT – Real-Time Monitoring & Control for Process Analytical Technologies
- Bruce Greenwald DeltaV Platform Business Development Manager, Emerson Automation Solutions
Synopsis
- 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
Synopsis
- 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
- Wei-Chiang Chen Associate Director, BioProcess Analytics, Genomic Medicine Unit, Sanofi
Synopsis
- 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 Networking Lunch
New PAT Technologies & Machine Learning Advances
1:30 pm Removing Bottlenecks to Real-Time Release in Biopharmaceuticals with PAT & Advanced Analytics
- Karin Balss Scientific Fellow, MSAT, Janssen Pharmaceuticals
Synopsis
- Use of PAT and advanced analytics for real-time quality awareness
- Removing redundancies in compendial release in drug substance and drug product
- Case Study: Replacement of bioburden IPC testing with in-line PAT and advanced analytics
2:00 pm Using Machine Learning to Improve Data Handling, Increase Data & Enhance Model Performance
- Elliott Schmitt Principal Engineer, Process Analytical Technology, Moderna
Synopsis
- 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
2:30 pm Increasing Efficiency On the Journey Towards Semi-Continuous Processes & Improved Real-Time Monitoring Through PAT Technology Implementation
- Dariusz Domagala Project Manager, Novo Nordisk
Synopsis
- 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
3:00 pm Afternoon Networking Break
Advancing Modeling & PAT Integration for Seamless Development & Manufacturing
3:45 pm Modelling Strategies as a Continuum Across Product Development & Manufacturing
- Benjamin Espen Principal Quality Engineer Lead, Avobis Bio, LLC
Synopsis
- Understanding trade-offs between causally accurate models and purely predictive models
- Building a systematic foundation during development that can enable PAT at scale
- Updating models with manufacturing data
4:15 pm Roundtable: Where is Everyone’s Baseline?
- Sarah Rajani Scientist, Process Analytical Technologies, Bristol Myers Squibb
Synopsis
- 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
5:00 pm Chair’s Closing Remarks
- Andreas Kunov-Kruse Senior Scientist, Analytical Technology in Manufacturing Development, Novo Nordisk Denmark