Global Industry Alignment on Continuous Processing
8:00 am Registration & Welcome Coffee
8:20 am Welcome & Chair’s Opening Remarks
8:30 am FireSide Chat
9:00 am ICH Q13 – What’s Next for Continuous Processing?
9:30 am Panel Discussion: Where Does the Implementation of CM Bring the Most Value?
10:00 am Current Production of Jetted Resins
10:30 am Structured Networking & Morning Coffee Break
Synthetic Molecules Track
Drug Substance Strategy for Advanced API Production
11:15 am Game Plan & Execution for Making Continuous Processing ‘the Norm’ in Small Molecules
Synopsis
• Fromcradle to grave: Lifecycle management for moving from batch-pivoting to firsttime- continuous for new products with a modular approach
• Tech Transfer from R&D to Commercial
• Implementing real time release
• Utilizing continuous processing to meet supply chain demands
• Commercial network strategy
11:45 am Batch to Continuous Technology: The Journey from Laboratory to Pilot Scale for DS Manufacturing
Synopsis
• Case study: Rapid implementation of continuous manufacturing capabilities from empty labs to pilot facility for commercial supply of Ipatasertib.
• Business case drivers
• Control strategy insights
12:15 pm Strategic Implementation of Continuous Processing at Sanofi, A New Supply Chain Paradigm
Biologics Track
Implementing Digitalization in Bioprocessing for Advanced Process Control
11:15 am Continuous Manufacturing for Biologics: Opportunities & Challenges
11:45 am Why Batch Can’t Match Multi-Column Chromatography: A Throughput Analysis
Synopsis
- Review batch chromatography limitations and their impact on process and business needs
- Compare batch and multi-column chromatography (MCC) modes of processing
- Scenario analysis of MCC in various processes
12:15 pm Round Table: Technology Transfer of Large Molecule Bioprocessing
Synopsis
• 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
12:45 pm Networking Lunch
Drug Product Strategy for Scalable OSD Production
2:00 pm Particle Engineering & Continuous Processing
Synopsis
• Tools to bridge the gap between drug substance & drug product
• Pilot scale test for continuous direct compression
• Workflow approach to development, digitalization, and deployment of new processes
• Practical considerations for implementation in value chain
2:30 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
3:00 pm Control for Achieving Desired Crystal Form in a Continuous Crystallization Process Scaled up to cGMP Manufacturing
3:30 pm Making CM more accessible: USP CM Knowledge Center, API process development, and capability building
Synopsis
How USP is helping the adoption of Continuous Manufacturing by:
• Developing a collaborative Knowledge Center
• Building a laboratory dedicated to CM API analytical process development, and
• Supporting manufacturers through end-to-end consulting for their CM
Automating Large Molecule Processing for Perfectly Pure Product
2:00 pm Enabling Downstream Continuous Processing with a Fully Automated & Integrated System
Synopsis
• The equipment and automation supporting Next Generation Manufacturing (NGM) for downstream unit operations can be complicated and expensive. In this talk we present an integrated solution for chromatography column operation, viral inactivation with pH control, filtration and in-line dilution
• This solution can lead to significant reductions in facility size, manufacturing costs, and enhanced product quality when compared to the usual batch mode of operation, or the alternative to integrate many different pieces of equipment through a Distributed Control System (DCS) from different vendors
• Details of operation, for the duration of a perfusion run, with bioburden control are explained
2:30 pm Standards support Continuous Manufacture
Synopsis
• The relevance of standards in a regulatory environment
• ASTM has a standard guidance for Continuous Processing and a work item for continuous biomanufacturer, aligning with ICH Q13
• Additional standards are available in support of enabling technologies (e.g. single-use, PAT, eData transfer, viral safety management)
• Desirable standards for unit operations upstream and downstream
3:00 pm Roundtable Discussion: Drug Substance Process Development for Biologics
Synopsis
• Which continuous processing technology would you consider as the most value-added? Why?
• What is your organization’s goal for adopting continuous processing? Single Step, leveraging useful technologies, or end-to-end approach?
• What is your organization’s decision making process on which technology should be adopted? Which functions are involved? What are the factors considered (Cost, time, production sites, etc.)?
• What effort or initiative would you like to see in biologics space to facilitate implementation of continuous processing?
• By comparing with Small Molecule production, what would you consider as challenges for implementing continuous processing on biologics production?
3:45 pm Afternoon Break & Poster Session
Synopsis
The annual CCP poster session is an opportunity to share your latest work with the KOLs in the continuous manufacturing space. Please see the
website for more details on poster submission.
Going Green through Novel Chemistry
4:14 pm Tech Transfer Timing & Green Chemistry to Accelerate & Advance Oncology Chemistry
Synopsis
• Investing time and resources into finding green and continuous solutions, after the proof of efficacy trigger has been pulled
• Internal collaboration to implement flow chemistry when working against the clock to expedite products to market
• Working in the pre-competitive space; how are various companies and industries valuing green chemistry in process development and manufacturing
4:45 pm Implementing Green Chemistry in Scale up from Lab to Commercial
Synopsis
• Case Study Fast Mixing Reaction; Reduction of PMI by running in flow & reduction of Carbon Monoxide by-product
• Greener Manufacturing of Belzutifan (MK-6482) Featuring a Photo-Flow Bromination
• Immobilized enzyme case study