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

  • Arlene Joyner Branch Chief CDMO Network, PCI/BARDA/ASPR/HHS
  • Thomas Warf Expert Consultant, PCI/BARDA/ASPR/HHS
  • Flavien Susanne Head of Drug Substance Process Development & Clinical Manufacturing, Sanofi

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

  • Fred Ghanem Director of Business Development, Purolite

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

  • William Hein Senior Director, Technical Operations, Small Molecule Platform, Janssen Pharmaceuticals

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

  • Jörg Sedelmeier Platform Leader, Continuous Flow Technology , F. Hoffmann-La Roche

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

  • Flavien Susanne Head of Drug Substance Process Development & Clinical Manufacturing, Sanofi

Biologics Track

Implementing Digitalization in Bioprocessing for Advanced Process Control

11:15 am Continuous Manufacturing for Biologics: Opportunities & Challenges

  • Andrew Chang VP Quality & Regulatory Compliance, Novo Nordisk

11:45 am Why Batch Can’t Match Multi-Column Chromatography: A Throughput Analysis

  • Karl Rogler Product Manager Chromatography Systems, Sartorius Stedim

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

  • Alastair Florence Director , EPSRC Future Continuous Manufacturing & Advanced Crystallisation Hub

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

  • Bart Rimez Co-Owner & Technology Lead , Secoya Technologies

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

  • Martin Johnson Senior Engineering Advisor, Process Design & Development , Eli Lilly and Company

3:30 pm Making CM more accessible: USP CM Knowledge Center, API process development, and capability building

  • Atul Dubey Principal Investigator (Director), Continuous Manufacturing, US Pharmacopeia

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

  • Irina Ramos Director Bioprocess Technology & Engineering , AstraZeneca

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

  • Chiali Liu Senior Director, Process Development, Biologics CMC , Teva

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

5:15 pm Continuous Extraction for Green Chemistry and Process Intensification

5:45 pm Women in Pharma Manufacturing Panel Discussion & Poster Award

6:30 pm Evening Reception