Translating Data into Regulatory Approval
8:30 am Day two Welcome
8:45 am Risk Benefit Considerations in Regulatory Applications
Synopsis
• 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
9:15 am Harnessing Modeling for Efficient Bio-Pharmaceuticals Process Development
Synopsis
• 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
9:45 am Panel Discussion: Measure Vs Model in CM Validation & Approval
Synopsis
• 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
10:20 am Continuous Processing in the Context of a Broader Pharmaceutical Development Technology Strategy
Synopsis
• 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
10:50 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
Synopsis
• 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 Session reserved for Bright Path Laboratories
12:30 pm Process Analytical Technologies in Novel Technologies
Synopsis
• Integrating PAT in Electrochemistry & Photochemistry flow reactions
• Scaling continuous flow telescopic steps on multi-kilogram scale
• Integrating digitalization in Self-Optimization & Automation
1:00 pm PAT Model Lifecycle Management
Synopsis
- Chemometric Model Lifecycle Manasgement
- Challenges and compliance Issues
- Enabling tools for support
- Examples from an oral solid dosage line
Biologics Track
PAT, Quality Control & Tech Transfer Control for Biologics
11:30 am PAT integration and Advanced Process Control for Continuous Biopharmaceutical Production
Synopsis
• 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
Synopsis
• 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 Advanced Process Control and Process Monitoring for Continuous: Towards a Smart Factory Autopilot
Synopsis
- What are the opportunities for improved process robustness and product quality using model-based techniques?
- How can we integrate different data sources and models to monitor and control continuous processes?
- What are the considerations for the validation of these models and APC systems?
- What can we learn from other industries?
- Case study examples from high value manufacturing including bio-pharmaceuticals.
12:45 pm The Future of Industrial-Scale Cell Cultivation
Synopsis
• Why the industry needs new technologies
• The limitations of batch bioprocessing and the potential of continuous solutions
• Applications for the technology
1:05 pm Continuous Processing Potential Outside of Traditional Small Molecule & Monoclonal Antibody Applications
Synopsis
• What technologies are available for cell, gene, and vaccine continuous manufacturing?
• How close are these technologies to commercialization? – How easy are commercially available technologies able to be adapted to process needs?
• What are the drivers for exploring CM for modalities outside of the traditional small molecules & monoclonal antibodies?
1:30 pm Networking Lunch
Automation in R&D
Facility Design and for Flexible Scale Up
2:30 pm Linking Discovery & Development through Automation & Democratizing Flow Process Development by Leveraging Automation
Synopsis
• 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
3:20 pm Equipment Design & Start Up for Lilly’s New Ireland Hybrid Facility
Synopsis
• 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