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

  • Petrus Johannes Geldenhuis Associate Director - Manufacturing & Supply Chain Data Engagement & Governance, Vertex Pharmaceuticals

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

  • Flavien susanne Head of Chemistry, Manufacturing & Controls Site, Drug Substance Process Development & Clinical Manufacturing, Sanofi

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

  • 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

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

  • Daniel Hogan Sr. Team Lead External Manufacturing North and South America, Bayer

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

  • Tim Lee Senior Scientist, Team Lead - Chemistry, Manufacturing & Control Synthetics, Sanofi

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?

  • Moiz Diwan Director - Pharmaceutical Development, Abbvie
  • Sarwat Khattak Head of Cell Culture Development Proteins, Biogen Idec
  • Petrus Johannes Geldenhuis Associate Director - Manufacturing & Supply Chain Data Engagement & Governance, Vertex Pharmaceuticals
  • Matthew Beaver Director - Process Development, Amgen Inc.
  • Daniel Hogan Sr. Team Lead External Manufacturing North and South America, Bayer

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?

4:25 pm Chairs Closing Remarks

4:30 pm Close of CCP 2023