Conference Day Two
7.45 am – 9.45 am Workshop A Optimizing Automation & Human Intervention in Continuous Processing
7.45 am Check in Morning Coffee & Light Breakfast
Navigating Regulatory & Compliance Challenges in PAT Implementation
9:55 am Chair’s Opening Remarks
10:00 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
Streamlining QC Testing to Enhance Production Speed & Quality
- Manoharan Ramasamy Director, Merck & Co
Synopsis
- Implementing PAT to perform QC tests more quickly and efficiently, cutting down the overall production lead time
- Incorporating QC tests into the production line using PAT for immediate results, enhancing process streamlining and reducing bottlenecks
- Utilizing PAT to handle various QC tests, including impurity limits and container integrity, ensuring comprehensive quality checks
11:00 am Morning Break & Networking
12:00 pm Strengthening Vendor Partnerships to Optimize PAT Solutions for Improved Production Efficiency and Quality
- Mark Henson Senior Scientific Fellow, Technology Lifecycle Implementation, Takeda Pharmaceutical
Synopsis
- Building robust relationships with vendors to ensure seamless integration of advanced PAT tools, enhancing overall production efficiency and quality
- Collaborating with technology providers to develop customized PAT solutions that meet specific manufacturing needs, driving innovation and process improvements
- Facilitating continuous communication and feedback with vendors, ensuring timely updates and advancements in PAT technologies, maximizing their impact on production processes
Enhancing Process Understanding & Control through Specialized Chemometrics Techniques & Quality Optimization
12:45 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
1:15 pm Lunch & Networking
2:15 pm Unlocking Process Insights With PAT & Advanced Chemometrics
- David Zamora Global Statistical & PAT Lead, Novartis
- Guanghui Zhu Senior Staff Engineer, Takeda Pharmaceutical
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
3:00 pm Roundtable Discussion: Enhancing Quality Control Through Compliance-Driven PAT Integration
- Mathieu Bibian Senior Manager Analytical Research and Development, GlaxoSmithKline
Synopsis
- Exploring the distinctions between online and offline QC testing within PAT systems
- Discovering strategies for ensuring compliance while maintaining flexibility in QC processes
- Examining key regulatory guidelines and frameworks governing PAT integration in QC environments
- Addressing common challenges and pitfalls in achieving regulatory compliance during PAT implementation
- Examining the importance of data integrity in PAT systems and impact on QC
3:30 pm Leveraging PAT for Process Optimization & GMP Compliance in Pharmaceutical Manufacturing
Synopsis
- Discuss the role of PAT in transitioning from R&D to full-scale industrial processes, ensuring efficiency and consistency in pharmaceutical manufacturing
- Highlight how inline analytics and PAT reduce the burden on QC teams by streamlining monitoring and control, leading to faster and more reliable outcomes
- Explore how the adoption of PAT not only optimizes processes but also helps in maintaining strict GMP compliance, ensuring product safety and regulatory adherence
Speaker tbc
Implementation Driving PAT Success: Enhancing Organizational Efficiency, Financial Performance and Talent Development
4:00 pm Optimizing Organizational Structures for Enhanced PAT Integration and Efficiency
- Emmanuel Appiah-Amponsah Director, Data Rich Measurements- Analytical Enabling Capabilities, Merck & Co
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