8:00am Registration & Morning Coffee
8:50 am Chair’s Opening Remarks
Advancing Lab Scale Continuous Manufacturing Using Automation & Analytics to Maximize Quality
9:00 am Exploring Amgen’s Insight Towards Process Technology Progression & Lab Automation to Enhance Efficiency for Small Molecule
Synopsis
- Moving towards industry 4.0 and innovative process technology to improve continuous manufacturing efficiency
- Understanding what is being actioned at early-stage process development to increase automation-aided continuous manufacturing
- Exploring how to use a flow-based experimental system to change pump flow rates in incorporating automation and data management
9:30 am Assessing Development of a Multi-Column Continuous Chromatography Process for Antibody Drug Conjugates
Synopsis
- Assessing the benefits of implementing continuous chromatography: evaluating the advantages of integrating continuous chromatography in ADC manufacturing
- Using mechanistic modeling for continuous chromatography optimization: applying mechanistic modeling to improve the development process for continuous chromatography in order to enhance efficiency and maintain purity
- Addressing scale-up considerations: discussing considerations for scaling up the continuous chromatography process and the advantages of using scale-down models
10:00 am LNP mRNA Drug product Continuous Manufacturing: Leveraging Single Vial Freeze Drying Unit Technology To Improve Drug Product Cycle Time & Stability
Synopsis
- Discussing single vial freeze drying technology presentation – equipment / process / PAT
- Exploring technology interest and limitations – footprint / Lyo cycle time / scale up is a scale out / development cycle time to market / GMP
- Exploring perspectives in the context of LNP mRNA : end to end integration from LNP self assembly to drug product manufacturing process
- POC sue case on LNP mRNA
10:30am Speed Networking & Refreshments
Shifting From Batch to Continuous Along the Production Line to Improve Flexibility & Manufacturing Efficiency
11:15 am Enhancing a Continuous Manufacturing process by Implementation of an Automatic Refill System
Synopsis
- Eliminating process pauses by installation of an automatic refill system has increased production capacity and process capability of a solid oral dosage form manufacturing process
- Understanding and navigating post approval changes of an established continuous manufacturing control strategy
- Reduction of material handling by expansion of capabilities and integration to an existing continuous direct compression system.
11:45 am Session Reserved for CONTINUUS Pharmaceuticals
12:15 pm Advancing Continuous Manufacturing in Cell & Gene Therapy for More Efficient Production
Synopsis
- Implementing PAT tools, including non-invasive instruments and cutting-edge analytics to facilitate process monitoring
- Contextualizing continuous processing for viral vector production to streamline cell and gene processes
- Tapping into opportunities for continuous manufacturing to drive broader adoption of cell and gene therapies in clinical and commercial settings
12:45pm Networking Lunch
Perfecting Process Modeling & Streamlining Your Strategy for Quality Outcomes
1:45 pm Case Study: Streamlining Sanofi’s Process Modeling for Drug Substance Manufacturing for Scale-Up Success
Synopsis
- Optimizing process modeling from development through to verification and scale up to minimize process errors
- Outlining Sanofi’s digital development for drug substance process modeling to explore opportunities for process efficiency
- Understanding current work being done to advance process modeling for drug substance
2:15 pm Roundtable Discussion: Evaluating Continuous Manufacturing for Your Drug Development to Help “Make the Shift” & Further Your Production Line
Synopsis
- What are priority factors when assessing process compatibility with continuous approaches?
- How do you approach a cost-benefit analysis to best consider ROI?
- Is continuous manufacturing truly the right way to go?
2:45 pm Session Reserved for CINC Industries
2:55 pm Leveraging Process Modeling & Risk-Based Decision-Making for Direct Compression to Facilitate the Transition to Continuous Manufacturing
Synopsis
- Utilizing process models to identify optimal process parameters for scale-up and minimizing tech transfer challenges
- Evaluating formulations to support decision-making for direct compression
- Integrating DS-DP process models and risk assessments to ensure direct compression strategies are robust and future-proofed for a smooth transition to continuous manufacturing when required
3:25pm Afternoon Break & Poster Session
Synopsis
Grab this opportunity to share your current work ahead of your process development and CMC peers to hear specialized feedback to make your processes greener, more cost-effective, and highly controlled.
Optimizing PAT Applications & Branching Out Across the Pipeline for Effective Production
4:00 pm Leveraging End-to-End PAT Applications From Exploration to GMP Implementation to Shorten Timelines Moving Towards Real-Time Release
Synopsis
- Exploring platform potential and portfolio strength to understand potential for investment in soft sensors to ensure ROI
- Obtaining conditional release during biologics continuous monitoring to help shorten timelines and move closer to RTR
- Addressing challenges surrounding late-stage implementation of PAT to equip for regulatory readiness
4:30 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