Translating Data into Regulatory Approval

9:00 am Panel Discussion: Measure Vs Model in CM Validation & Approval


• What measurements can be replaced with a model, whilst retaining product quality and regulatory compliance?
• How can regulatory approval for CM differ across the world?
• Key differences between traditional bath processing vs continuous in regulatory submission, e.g. continuous process validation
• Inspection preparedness as we move into commercial space

9:45 am Risk Benefit Considerations in Regulatory Applications


• Bridging the gap between case-by-case approach and predicting what regulators need
• With multiple considerations, continuous validation, real time release testing ect. how to prioritize and communicate in global dossier preparation
• Balancing the data with the story: Seeing the big picture to translate technical data into concise, quality control strategy

10:15 am Harnessing Modeling for Efficient Bio-Pharmaceuticals Process Development


• Platform approach to understand key CMC processes for both the small and large molecules
• Pragmatic modelling to troubleshoot and optimize processes
• Utility of digital twins across various modalities including continuous processing

10:45 am Structured Networking & Morning Coffee Break

Synthetic Molecules Track

PAT, Modelling & Quality Control for Synthetic Molecules

11:30 am The Business Case for Drug Substance Continuous Manufacturing: A Modeling & Simulation Perspective

  • Carla Luciani Senior Director, Chemical Engineering, Vertex Pharmaceuticals


• Brief introduction to the challenges faced when building a business case for drug substance continuous manufacturing
• Discussion of potential strategies pros and cons
• Modeling and simulation beyond process design and development: How do support your business case?
• Case studies

12:00 pm Process Analytical Technologies in Novel Technologies

  • Frederic Buono Senior Associate Director, Chemical Process Development US , Boehringer Ingelheim


• Integrating PAT in Electrochemistry & Photochemistry flow reactions
• Scaling continuous flow telescopic steps on multi-kilogram scale
• Integrating digitalization in Self-Optimization & Automation

12:30 pm PAT Model Lifecycle Management


Advanced diagnostics and troubleshooting techniques to build confidence in process
analytical technologies

Biologics Track

PAT, Quality Control & Tech Transfer Control for Biologics

11:30 am PAT integration and Advanced Process Control for Continuous Biopharmaceutical Production


• Continuous perfusion-based mAb production processes
• Control and prediction of critical process parameters and quality attributes based on real-time data
• Integration of smart 3D-printed microfluidics into continuous bioprocesses

12:00 pm Sensing Technology and Process Requirements


• PAT in the product life cycle – how to connect process needs with technology
• PAT technology readiness: what’s out there, what’s needed?
• Data engineering for PAT
• Compliance aspects – data integrity and GMP, monitoring vs. controlling

12:30 pm Round Table: Technology Transfer of Large Molecule Bioprocessing


• How to communicate a clear, well-defined strategy that addresses scope, timeline, and resources at both the transferring and receiving site.
• Ensuring open and honest sharing of materials between sponsor and CDMO
• Defining roles and responsibilities

1:00 pm Networking Lunch

Facility Design and for Flexible Scale Up

2:00 pm Equipment Design & Start Up for Lilly’s New Ireland Hybrid Facility

  • Bruce Parker Associate Engineering Advisor , Eli Lilly & Co


• Development & design of continuous manufacturing equipment for new hybrid facility: integrating batch and continuous processing
• Collaborating with vendors in conjunction with Lilly’s in-house continuous equipment design expertise
• Pitfalls in working with custom continuous vendors in a GMP environment
• Communication with process development teams to ensure required infrastructure is understood and delivered, and remaining flexible as process
needs develop
• Forecasting timelines for facility start-up, to expedite speed to market whilst remaining realistic

2:30 pm Building the First-of-Its-Kind Integrated Continuous Manufacturing Facility in the US

  • Ernest Penachio Vice Presentation of Technical Operations , CONTINUUS Pharmaceuticals

3:00 pm Afternoon Refreshment Break

Automation & Digital Transformation in the Future of Drug Discovery & Development

3:45 pm Continuous Processing in the Context of a Broader Pharmaceutical Development Technology Strategy

  • Mark Henson Senior Scientific Fellow and Head, Technology Excellence, Takeda


• Continuous processing value proposition for development vs. commercial organizations
• Roadmap approach facilitates parallel implementation of critical supporting Pharma 4.0 elements
• Modality-agnostic platform digital architectures and project frameworks facilitate rapid adoption

4:15 pm Linking Discovery & Development through Automation & Democratizing Flow Process Development by Leveraging Automation


• Introduction to the process and enterprise benefits of continuous flow processing.
• Overview of our development strategy for implementing flow in our pipeline projects.
• Introduction to our automated flow synthesis instrument, the FlowSI, a tool designed for democratizing flow chemistry and reducing barriers to entry
• Discussion of how lessons learned in the lab can be quickly scaled to pilot plant and production, giving patients quick access to remarkable therapies

5:05 pm Automation Q&A


As we move towards Pharma 4.0 and digitization, there are multiple stakeholders and user considerations to take into account in addition to the IT infrastructure roll-out. This is
your opportunity to fire your burning questions to gain the best tips from our expert speakers to smooth out your transformation!

5:15 pm Chair’s Closing Remarks

5:30 pm Close of CCP 2022