8:00am Registration & Morning Coffee
8:50 am Chair’s Opening Remarks
Accelerating Clinical-to-Commercial Development to Drive Yields
9:00 am Continuous Manufacturing: Bridging Clinical Phase Studies to Commercial Product for Small Molecules
Synopsis
- Internal interactions and development strategy continuous manufacturing
- Understanding how to use a bridging study to communicate process similarity to health authorities and regulators for streamlined approval
- Outlining the use of modeling to aid bridging studies for similarity demonstrations formaximal efficiency
9:30 am Leveraging Process Optimization for Cell Therapy to Enhance Speed-to Market & Efficiency
Synopsis
- Redefining continuous processing in the context of cell therapy for holistic clarity
- Navigating the complexity of cell therapies during continuous manufacturing to streamline development
- Futureproofing the cell therapy supply chain with facilities and location in mind to deliver drugs faster
10:00am Morning Coffee Break
Moving Towards Complete Integration Along the Production Line to Maximize Flexibility & Minimize Spend
10:30 am The ‘new world’ continuous. Designing a continuous processing plant using DEC’s advanced configurable process plant (ACPP)
Synopsis
- DEC Group is a leading supplier of true end-to-end solutions, continuous and hybrid systems. Alconbury Weston Ltd (AWL), part of the DEC Group, supplies continuous processing equipment, including reaction, extraction, crystallisation and filtration/drying equipment.
- AWL will demonstrate how Modular Type Packages (MTP) can be used to allow for flexible and configurable connections of unit operation modules, and how this can deliver a multi-modular advanced configurable process plant (ACPP) for both development and production.
- Case Studies will be presented describing the translation from lab to Production scale Systems.
11:00 am Panel Discussion: Recognizing Emerging Modalities for Continuous Manufacturing Applications to Advance Your Pipeline & Meet Demands
Synopsis
- How are emerging modalities adapting to continuous manufacturing?
- How must continuous manufacturing evolve as a standardized method for cell and gene therapy production?
- Where are the gaps in transitioning from small to commercial scale for continuous manufacturing of biologics and novel modalities?
11:45 am Demonstrating a Path to Commercial Scale Production
Synopsis
- In an effort to test whether commercial scale production could be achieved in continuous mode, PAK BioSolutions created the largest scale automated continuous processing skid and ran it at 12,000 liters per day
- Buffer run data demonstrated flow rates, mixing, titration, and vessel level control at this large process scale
- In conclusion, it is feasible to run commercial scale production on an automated continuous processing skid as shown by PAK BioSolutions
12:00pm Networking Lunch
Assessing Value Added for Sustainability & Green Chemistry to Meet ESG Goals
1:00 pm Exploring Pfizer’s Modular-Based Approach to Flow for Indirect API Production to Refine Your Technical & Strategic Approach
Synopsis
- Outlining strategy optimization when considering flow to produce starting materials in a continuous fashion
- Addressing implementation of technologies fit for continuous flow for seamless integration
- Quantifying sustainability measures to overcome the data scarcity bottleneck and maintain green processes
1:30 pm Exploring Next Generation Business Drivers for CM & The Role of Technology
Synopsis
- Describing the emerging business needs and operational strategy for innovative companies regarding continuous manufacturing
- Identifying how current technologies and utilization cases are evolving to meet these needs
- Asking how can further developments in technology, regulatory landscape, and external capabilities continue to progress and drive CM as the go-to manufacturing platform
2:00 pm Roundtable Discussion: Unlocking the Future of Small Molecule Commercialization: The Role of Continuous Manufacturing
Synopsis
- How can continuous manufacturing streamline the development-to-commercialization timeline for small molecules, and what key challenges need to be addressed to fully leverage its potential?
- What regulatory considerations and industry standards are critical for scaling continuous manufacturing in the small molecule sector?
- How can continuous manufacturing improve supply chain resilience and flexibility in the commercialization of small molecules?
2:30pm Afternoon Break
Getting Ahead of the Curve: Exploration of Novel Digital Tools & Advancements for Added Layers of Efficiency
3:00 pm Applying a Cross-Modality Perspective to Advance the Manufacturing of New Drug Modalities
Synopsis
- Understanding how to leverage synthetic molecule techniques for biologics to facilitate progression for newer modalities
- Applying rationale for continuous crystallization of small molecule to biologics continuous processing to tap into uncovered opportunities
- Addressing the mindset and skillset required to apply from small molecule to biologics to shorten time to market for all therapeutics
3:30 pm Exploring Membrane-Based Antisolvent Crystallization for Nanocrystals in Continuous API Manufacturing
Synopsis
Leveraging membrane-based antisolvent crystallization to continuously produce nanocrystals of various APIs
• How membrane technology can support a streamlined, scalable, and sustainable API production process for API nanocrystals
• Eliminates milling processes to obtain nanocrystals from microcrystals and minimizes operational challenges in pharmaceutical manufacturing
4:00 pm Working With Digital Twins to Improve Continuous Manufacturing & Explore Future Industry Potential
Synopsis
- Outlining how to begin implementation of digital twin-aided continuous manufacturing to direct real-time processes with minimal error
- Exploring challenges and opportunities in digital twin data management to increase accuracy and efficiency
- Exploring potential industry applications for digital twins paired with continuous manufacturing to shed light on innovation