Jan 29 – Jan 31, 2019
Boston, MA

Day One
Wednesday January 31, 2018

Day Two
Thursday February 1, 2018

Coffee & Refreshments

Chair’s Opening Remarks

Commerciality of CM

Opening Address: Manufacturing the Future: The Journey from Batch to Continuous Manufacturing from an Industry Perspective


• Janssen’s historic FDA approval – gaining key insights into the successful change from batch to continuous manufacturing of Prezista®
• Understanding the vision and strategy for deployment of continuous manufacturing at Janssen
• Challenges and path forward – addressing the implementation of CM in development

  • API needs
  • Tech transfer

Continuous Small Molecule API Manufacturing: Development & Technology Transfer to a CMO

  • Kevin Cole Principal Research Scientist, Small Molecules Design & Development, Eli Lilly & Co.


• Discover the case for and status of small molecule continuous processing at Eli Lilly
• Developing a multi-step fully continuous process
• Assessing the selection criteria and transfer of key elements of the continuous process to a CMO

How a Key Customer Collaboration Lead to the Development and Deployment of Advanced Separations Technology (UPLC) into Their CM Process and Beyond

  • Ernie Hiller Principal Systems Manager, Waters Corporation


  • Separations technology is the gold standard in delivering information rich with quantitative results for their process and product in the QC laboratory: however for the PAT initiative does not meet the need
  • Introducing a major breakthrough in separations technology which combined all elements of a chromatographic system: from chemistry, instrumentation, software to service was introduced, and how this combined increase in speed, sensitivity and resolution which will now meet the needs of the PAT initiative
  • With this advancement in separations technology systems lead to a key collaboration with a major pharmaceutical company to develop a fit for purpose PAT system that could be directly connected to their process and in addition provide key information about their process and product back to their DCS for close loop communication and control
  • What have been the lessons learned from this collaboration and others that followed

Morning Refreshments and Networking

Mastermind: Redefining Continuous Manufacturing Workflow


In this session, delegates will be split into groups of 10 to brainstorm and share ideas
and challenges in the following areas for transitioning to CM:

  • Continuous operation as a post approval change: can we switch to continuous operation for a product that has been developed and launched as a batch process without repeating the clinical trials? What needs to be demonstrated? What are the requirements for the continuous setup?
  • How do we define a batch and release the product? How do we correlate the drug substance to the raw materials and process data?
  • What is the sensible campaign length? What are the limitations? How do we validate very long production campaigns? What is the flexibility of continuous processing regarding amount of product per campaign? 

As discussed in previous presentations, workflow, process steps and involved
stakeholders require a completely different approach, while integrating nicely
to ensure a secured control strategy. We will share the results with the rest of the
attendees at the end of this session to help redefine best practice.

The Supporting Act – Technology Advancements to Enable CM

The Roll Out – Smooth Implementation of Continuous Manufacture of Small Molecules


• Applying QbD throughout product development to ensure absolute control over the quality of end products
• Formulation considerations for continuous manufacture
• Why collaborate? Collective approach to tackle common challenges and accelerate implementation

Lunch & Networking

Bridging Continuous, Integrated & Batch Processing as a Path to Implementation

  • Jon Coffman Global Head of Innovation, Technology Biopharm, Boehringer Ingelheim


• Discussing how the largest issue in continuous and integrated processing is not technology – it’s stakeholders
• Understanding how Boehringer Ingelheim’s continuous and integrated technology was developed to satisfy stakeholders to achieve implementation
• Evaluating targeted hybrid systems to bridge the gap between a batch culture and a continuous processing future

Continuous Process Development & Monitoring

  • Jana Spes Head of CMC & Supply Chain, Boston Biomedical


• Maintenance and update of models correlating process signals to CQAs
• What are the requirements from FDA and ICH?
• Advantages of CP in generics and biosimilars market and how it can address challenges with existing capacity

Chair’s Closing Remarks

Close of Conference