Conference Day Two
8.15 am Check in Morning Coffee & Light Breakfast
8:55 am Chair’s Opening Remarks
9:00 am Optimizing Aseptic Production Efficiency via PAT-Driven Process Validations
- Andreas Kunov-Kruse PAT Specialist, Novo Nordisk
Synopsis
- Explaining PAT as a cornerstone in future Process Validations and a key enabler for OPV/CPV increasing
- Reducing Validation Time to Increase Throughput in Aseptic Production and serve more patients
- A new multimodal spectroscopy approach enables more accurate PAT-based process models
9:30 am Applications of PAT for Bioconjugation Processes
- Kim nguyen Senior Scientist, MilliporeSigma
Synopsis
- PATROL-SEC and/or Flow VPE can facilitate real time protein monitoring in ADC process
- PATROL-UPLC-SEC-DTNB has been applied to monitor bioconjugation process
- ProCellics™ Raman Analyzer with Bio4C® PAT Raman Software can be used to monitor solvent clearance in TFF processes
10.00 am Morning Break & Networking
11:00 am Optimizing Liquid Chromatography for Superior Process Efficiency and Control
- Jeff Elleraas Senior Scientist, Pfizer
Synopsis
- Implementing liquid chromatography systems to improve precision and reduce solvent usage, enhancing sustainability and operational efficiency
- Facilitating real-time data collection and immediate process adjustments through on the spot
analysis with portable liquid chromatography systems - Integrating liquid chromatography with continuous flow systems to ensure seamless
monitoring and control throughout the production process
11:30 am Roundtable: Managing Complexity in Gene Therapy Manufacturing
- Shashi Prajapati Associate Director, Vertex
Synopsis
- Managing the complexity of gene therapy production by maintaining precise control over multiple variables
- Using sophisticated PAT tools to monitor and control transduction efficiency and vector potency
- Implementing detailed monitoring to ensure the stability and efficacy of the final gene therapy product
12:00 pm Enhancing Industrial Process Monitoring Through Multivariate Statistical Techniques
- Samira Beyramysoltan Senior Scientist, GlaxoSmithKline
Synopsis
- Exploring multivariate statistical methods and their applications in process monitoring
- Identifying the main challenges including model development, limited batch data, and model maintenance
- Implementing strategies for overcoming these challenges, such as using simulated batches and adaptive modeling
12.30 pm Lunch & Networking
1:30 pm Unlocking Process Insights With PAT & Advanced Chemometrics
- David Zamora Global Statistics and PAT Lead, Novartis
Synopsis
- Utilizing advanced PAT techniques to gain a comprehensive understanding of complex process interactions and variables
- Leveraging chemometric models to support data-driven decision-making, improving process reliability and product quality
- Applying mechanistic modeling to pinpoint critical process drivers, enabling targeted process improvements and optimizations
2:00 pm Balancing Automation & Human Intervention in Continuous Processing for Optimal Efficiency
- Arsh Vyash Research Data Scientist, Vertex
Synopsis
- Explore technical integration of advanced automation systems into existing workflows, addressing challenges in compatibility, interoperability, and scalability
- Focus on upskilling personnel to manage and collaborate with automated systems, using real-time data to enhance decision-making and process control
- Implement sophisticated error detection and correction in automated systems to ensure product quality, reduce downtime, and adapt to changing production demands
2:30 pm Optimizing Organizational Structures for Enhanced PAT Integration and Efficiency
- Emmanuel Appiah-Amponsah Director, Data Rich Measurements - Analytical Enabling Capabilities, Merck
Synopsis
- Integrating PAT teams within process development or analytical teams ensures effective usage, enhancing process understanding, control strategies and release testing
- Facilitating collaboration between development and manufacturing teams prevents delays and promotes seamless PAT integration into commercial manufacturing
- Aligning organizational structures to support analytical validation of RTRT improves accuracy and compliance in real-time data assessment