Global Industry Alignment on Continuous Processing
8:00 am Registration & Welcome Coffee
9:00 am Welcome & Chair’s Opening Remarks
9:15 am ICH Q13 – What’s Next for Continuous Processing?
Synopsis
• What do the ICH Q13 guidelines mean for the future harmonization of global regulatory and industry acceptance of continuous processing
• Following recent public consultation; what are the possible changes to this document
• ICH Q13 EWG’s areas of focus moving forward and what now needs to be done by regulators and industry to make continuous process common place in pharmaceutical manufacturing
9:45 am Panel Discussion: Where Does the Implementation of CM Bring the Most Value?
Synopsis
• Legacy vs Pipeline Products: Contrasting a potentially quicker time to market with saved manufacturing costs, what brings the most value?
• What are the switch points to move into continuous at R&D, Early Phase or Late Phase?
• Which modalities stand to benefit the most from this technology?
• As drug move off patent – how will the generics market influence the continuous manufacturing landscape
10:30 am Structured Networking & Morning Coffee Break
Synthetic Molecules Track
Drug Substance Strategy for Advanced API Production
11:30 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
12:00 pm 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
12:30 pm Supplying Commercial Pharmaceutical Materials using Continuous Flow Processing
Synopsis
• Scaling up from kilos to multi-ton for global leading pharmaceutical companies
• State-of-art manufacturing facilities, with the capability to manufacture APIs
and intermediates
• Continuous flow processing has many advantages over traditional batch processes; it is not just greener, highly efficient, cost-effective, and regulatory support; but also has the capability to conduct low-temperature reactions, hazardous reactions (azide/ hydrogen peroxide, etc.), catalytic reactions, and other extreme chemistries not possible by batch processing
Biologics Track
Implementing Digitalization in Bioprocessing for Advanced Process Control
11:30 am Continuous Manufacturing for Biologics: Opportunities & Challenges
Synopsis
• What are the central questions and business opportunities for introducing continuous manufacturing (CM) for biologics?
• What are the opportunities and challenges ahead for wider spread adoption and application of CM for biologics
• A case study: Post-approval change of upstream manufacturing process to CM
12:00 pm End to End Processing in Large Molecules/ Biologics
Synopsis
• Challenges in the integration of upstream and downstream bioprocesses
• Long term vision for scale up and supply chain
• Forecasted business case/ cost saving for end to end model
12:30 pm Continuous Manufacturing of Agarose Resins and Its Applications
Synopsis
• Jetting of uniform agarose particles
• Cost effective purification of mAbs with Praesto jetted protein A resin
• AVIPure affinity resins for continuous processing of non-mAb
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
Synopsis
• In light of ICHQ13 discussions we anticipate that regulators will request PAT to verify real time that continuous drug substance processes are operating at state of control. In a 3-step continuous process that we ran in cGMP manufacturing, PAT was used at the outlet of 3 different continuous reactions running simultaneously, but PAT was not used for the continuous crystallization of the final API
• A robust form control strategy was designed, developed, and proven at pilot scale, primarily using mass flow rate and temperature parameters, mass balances, vapor-liquid equilibrium, and knowledge of feed concentrations, to achieve the desired anhydrate form
• Regulators may request PAT to verify correct form in real time, especially because API exiting the MSMRPs accumulates in batches that each span several days of operation, and there is not way to separate out monohydrate from crystals from the batch downstream. However, this presentation will explain why on-line analytical was not necessary in this embodiment of continuous evaporation, crystallization, and filtration in order to achieve the desired anhydrate crystal form robustly and reliably
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 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?
3:00 pm Biologics Tech Slam
Synopsis
With the advancement of novel biologics processing platforms, we will take this moment for a biologics tech slam to get us equipped with the latest solutions to enable continuous bioprocessing.
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
5:15 pm Continuous Extraction for Green Chemistry and Process Intensification
Synopsis
• Discussion of the advantages of continuous extraction compared to batch extraction
• Introduction to continuous extraction: devices, contacting patterns, and theory
• How to design and scale-up continuous extraction for API manufacturing processes with an emphasis on minimizing solvent use
• Case study of continuous extraction with discussion of the solvent reduction and process improvements compared to batch extraction