8:00 am Morning Coffee
9:10 am Chair’s Opening Remarks
What’s next for Early Adopters?
9:15 am Continuous Manufacturing 2.0
Synopsis
• Need for development suite with all unit operations available that can be joined together in flexible and modular configurations
• Challenges in developing an automation system to suit and reflections on existing rigs
• Advantages of developing a new suite of operations which is more transferable to a CMO
9:45 am Flow by First Intent: Positioning CM as a Financial Solution vs Technical Driver
Synopsis
• The top-down strategy implemented at Sanofi resulting in a strategic investment for laboratory, clinical and commercial capability growth
• transformational change in the Pharma industry towards continuous and the application as flow by first intent in Sanofi
• How this approach led to engagment of Head of R&D & Head of Manufacturing, and the benefits of winning buy in for top-down
implementation strategy
10:15 am Coffee Break & Networking
Small Molecules Track
Emerging Technologies to Cover Drug Substance Design Space
11:30 am An Enabling Technology for Commercialization of a Synthetic Peptide – Continuous Manufacturing of Tirzepatide Using Online UHPLC-based PAT
Synopsis
• How to apply these processes at commercial scale
• Outlining the nuances of applying PAT tools in the GMP environment
12:00 pm We Are Building It .. & They Are Coming!
Synopsis
• Emerging and Enabling Technologies can significantly improve our processes and could
help us achieve what may not be readily possible currently
• AbbVie is exploring and developing many such technologies through internal and external
collaborations, and the presentation will highlight some of them
• The presentation will also share a couple of case studies where the use of membrane
technology significantly improved the process
12:30 pm Continuous Flow Process Development for a Radical Chlorodifluoromethylation Reaction
Synopsis
• Development of a flow process for a fast exothermic reaction with thermally unstable
reactants and a product prone to decomposition
• Further optimization of the flow process was completed in a second-generation process to
avoid reactor fouling issues
• The first-and second-generation processes were successfully scaled-up in a GMP facility
at the multi-kilogram scale
1:00 pm Secoya Crystallization Technology: Upscaling Crystallization Processes Using a Single Reactor Type from the Lab to Production
Synopsis
• Comprehensive outlook on the paradigm shift towards spontaneous nucleation of small
organic molecules in solution
• How to approach nucleation in the three dimensional space: concentration, temperature,
hydrodynamics
• Detailed discussions on several practical case studies
• Introduction to the Secoya Crystallization product line
Biologics Track
GMP Bioprocessing for Scale Up Success
11:30 am Technology Implementation in GMP Stainless Steel Facilities
12:00 pm Utilizing Modelling & Simulation to Facilitate Advanced Process Control, Integration of Biopharma Upstream & Downstream Processes for Continuous Manufacturing
Synopsis
• High precision and accuracy is required to break the industry 2-3 sigma level. Modelling
and simulation has been recognized as a key enabler to achieve the goals of continuous
manufacturing. Digital twin, the broad spectrum of modelling and simulation, is now being
strongly advocated by regulatory agencies such as EMA and FDA.
• In this presentation, Biogen will walk you through how to utilize robust modelling and
simulation to facilitate advanced process control and connection of upstream and
downstream processes for continuous manufacturing.
1:00 pm Q&A
1:00 pm Round Table Discussion: Challenges for GMP Continuous Bioprocessing Maintaining process and separation efficiency upon scale up
Synopsis
Round tables are moderator-led audience discussions, where the audience can share their
questions, feedback and experiences on a set topic, following a short introduction to the
topic from the moderators
1:30 pm
Networking Lunch
Ensuring the Physical & Digital Infrastructure for Continuous Manufacturing’s Next Step
2:30 pm Communicate, Educate & Evaluate; The Recipe for Success in CDMO Partnership & Validation
Synopsis
• How to approach the evaluation true CDMO capability and tracking quality throughout partnership
• Timelines and commutation for smooth tech transfer
• Validation of processes at commercial scale
• How transferrable are continuous manufacturing processes between sites – can you validate at one site and move to another?
3:00 pm Execution of Continuous-by-First-Intent Portfolio With Commercial Examples
Synopsis
• Ensuring infrastructure and capabilities for commercial continuous manufacturing
3:30 pm Presentation from Poster Prize Winner
3:40 pm When will the Infrastructure be In Place for Continuous to Overtake Batch?
Synopsis
• Evaluation of currently available external manufacturing infrastructure for small and large molecules, is this ahead, behind or inline with in-house?
• What needs to be overcome for continuous to overtake batch as the preferred method of production cross the industry?
• How to adapt continuous equipment suites so they are as flexible as batch sets ups? Which is particularly important for CMO models?
• Is modularization the answer to enable adaptable process flow? Contrasting a hybrid approach for integrated continuous manufacturing vs end-to-end
• How can CM be leveraged to speed up development into commercial production? When is the right time to go continuous in the life cycle of the drug?