8:30 am Morning Coffee

9:05 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


• 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, Drug Substance, Process Development & Clinical Manufacturing, Sanofi


• 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 Session Reserved for Dec Group

10:45 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


• How to apply these processes at commercial scale

• Outlining the nuances of applying PAT tools in the GMP environment

12:00 pm Digital Solutions to Facilitate Adoption of Continuous Manufacturing

  • Katie Baumer Pharmaceutical Continuous Manufacturing Community Engagement Manager,, U.S. Pharmacopeia


  • Supporting the innovation of CM through funding from US FDA and National Institute of Pharmaceutical Technology (NIPTE) by addressing barriers to CM adoption via a digital platform designed for industry, academia, and regulators 
  • Providing a user-friendly online space to discuss, comment, and collaborate on research and best practices and solve collective problems 
  • Enabling aspiring adopters to engage with experienced practitioners and find curated and contextualized research, news, and events in one location 
  • Creating a knowledge solution to increase efficiency and harness the collective expertise of CM professionals 

12:15 pm We Are Building It .. & They Are Coming!


• 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

12:45 pm Continuous Flow Process Development for a Radical Chlorodifluoromethylation Reaction


• 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

Biologics Track

Bioprocessing Control for GMP

11:30 am What is ‘Success’ for PAT in Continuous Bioprocessing?

  • Sarwat Khattak Head of Cell Culture Development Proteins, Biogen Idec


What areas of bioprocessing benefit from continuous unit operations with PAT application? 

How useful is Process analytical technology (PAT) for process ‘success’ from 

a) A regulatory point of view 

b) A manufacturing point of view 

Raman probe and other analytical techniques that drive value 

12:00 pm CIP Cleaning Sustainability

  • Fred Ohsiek Sr Global Technical Consultant, Ecolab Ltd


  • Elements of an optimized cleaning process
  • How to efficiently optimize a CIP cleaning process 
  • Hidden benefits of optimizing legacy cleaning processes

12:30 pm Utilizing Modelling & Simulation to Facilitate Advanced Process Control, Integration of Biopharma Upstream & Downstream Processes for Continuous Manufacturing


• 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 Control Strategy: Telling the Story

  • Ciby Abraham Senior Director and Group Manager, Project and Product Leadership, AstraZeneca


• Clearly communicating the control strategy utilization of raw material specifications, inprocess

tests, process monitoring and controls, and end-product testing

• What is must-include, and how to translate into a meaningful story?

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


• 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 Digital Twins for Biologics and Small Molecules for Next Gen Manufacturing


• Ensuring infrastructure and capabilities for commercial continuous manufacturing

3:30 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
  • Daniel Hogan External Manufacturing Team Lead, Bayer


• 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?

4:15 pm Chairs Closing Remarks

4:30 pm Close of CCP 2023