Conference Day Two - Thursday September 11, 2025

8:15 am Check In, Coffee & Light Breakfast

8:55 am Chair’s Opening Remarks

Navigating The PAT Regulatory Landscape & GMP Standards

9:00 am Adoption of Process Analytical Technology: Regulatory Frameworks, Recent Updates, & Industry Support for Use of PAT in Drug & Biologic Manufacturing

Synopsis

  • Discussing regulatory challenges and barriers to the adoption of PAT in drug and biologic manufacturing
  • Clarifying key expectations and updates in recent FDA, USP and global regulatory guidelines
  • Highlighting case studies that illustrate regulatory best practices and lessons learned
  • Identifying tools and strategies to align PAT implementation with regulatory expectations during development and lifecycle management

9:30 am Roundtable: Discussing Regulatory Hurdles Specific to Drug Modalities to Understand Differences & Identify Parallels

Synopsis

  • Bring forward the regulatory hurdles in advancing PAT tools for small molecule production
  • Pinpoint the GMP compliance challenges in production of biologics
  • Exploring the potential regulatory hurdles in applying PAT to CGT

10:30 Morning Break & Refreshments

Integration of PAT in Existing Drug Manufacturing Spaces

11:30 am Overcoming Challenges in Retro-Fitting MSPM Models into Existing Facilities to Unlock Process Efficiency & Real-Time Control

  • Lenora Dieyi Modeling & Simulation Engineer, Investigator, Sterile Drug Product Development, GSK

Synopsis

  • Overview of MSPM: Introduction to Multivariate Statistical Process Monitoring (MSPM), its definition, and its benefits in improving process anomaly detection
  • Techniques and Tools: Presentation will cover the tools, statistical methods, and software systems that enable effective MSPM
  • Addressing Challenges: Discussion on common MSPM challenges, such as nuisance alarms and user interface issues, along with proposed improvement strategies
  • Adoption and Enhancements: Insights into driving MSPM adoption, including enhancements needed for tool flexibility, modular environment setups, and data expansion
  • Future Developments: Exploration of future MSPM advancements, focusing on model lifecycle management and integration with advanced data sources for refined process monitoring

12:00 pm Scaling Raman-Based Continuous Monitoring for Metabolites: From Lab Models to Manufacturing

  • Veera Padmanabhan Executive Director, Head of Manufacturing Sciences and Technology, AstraZeneca

Synopsis

  • Explore the use of Raman spectroscopy for real-time, inline monitoring of key metabolites such as glucose and lactate during cell culture processes
  • Learn how advanced modelling techniques are being used to correlate metabolite levels with cell growth, enabling predictive insights into bioprocess performance
  • Hear about the journey of scaling Raman-based monitoring from lab development to full-scale manufacturing, including challenges, lessons learned, and implementation strategies

12:30 pm Lunch & Networking Break

Investigating PAT’s Applications In Biologics

2:00 pm Enabling Inline Sensing & Automated Sampling for Cell Culture & Beyond

Synopsis

  • Enabling long-duration bioprocess runs through sterile, automated sampling platforms
  • Integration of liquid handling systems with analytical devices for real-time insights into critical quality attributes (CQAs)
  • Practical considerations for implementing PAT and automation in non-GMP (process development) settings—and scaling toward GMP environments
  • Opportunities and roadblocks in deploying PAT tools for cell culture and CAR-T workflows

2:30 pm Accelerating mRNA-LNP Drug Product Release with In-Line Soft Sensors for Real-Time Testing

Synopsis

  • Replace traditional off-line osmolality testing with a non-destructive, in-line soft sensor using refractive index and UV data
  • Improve process efficiency and control by reducing QC burden and enhancing process visibility

3:00 pm Optimizing Raw Materials in Bioprocessing: Leveraging Chemometrics & Multivariate Analysis for Process Performance

  • Preeya Boppana Director, Manufacturing Science & Technology, Process Analytics & Laboratories, AstraZeneca

Synopsis

  • Examine the challenges of working with complex and chemically undefined raw materials in cell culture and how they influence bioprocess outcomes
  • Discover how chemometric modeling is used to analyze interactions between raw materials and their impact on process performance
  • Learn how multivariate analysis is applied to match specific raw material lots with product requirements, improving consistency, yield, and quality

3:30 pm Afternoon Break & Refreshments

Bridging the Gap from Development of PAT Models & Tools to Drug Manufacturing

4:00 pm Case Study: Exploring the Challenges in Transferring from Development to Manufacturing to Optimize Quality

  • Sankaran Anantharaman Head of Process Analytical Technology & Innovation Labs -Principal Research Scientist II, Analytical Sciences, Product Developme, Abbvie

Synopsis

  • Identifying the challenges in transferring PAT tools and models from development spaces to drug manufacturing facilities
  • Exploring strategies to develop robust PAT tools that can transfer to manufacturing to industrialise these solutions

4:30 pm Overcoming Bottlenecks in PAT Deployment: Bridging the Gap Between Lab & Manufacturing

  • Ramila Peiris Director & Head of Data Science, Manufacturing Technology, Sanofi

Synopsis

  • How to improve industrial systems and data infrastructure to better deploy PAT solutions at the manufacturing level, addressing gaps between lab-based models and large-scale production environments
  • Developing systems that ease the integration of these technologies into full-scale manufacturing while ensuring data accuracy and regulatory compliance

5:00 pm Chair’s Closing Remarks & End of Conference

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