7:00 am Registration & Morning Refreshments

8:00 am Chair’s Opening Remarks

Where is Continuous Manufacturing Today?

8:15 am Panel Discussion: Emerging Technology to Maturing Capability, Where is Continuous in the Technology Adoption Life Cycle?


• As the ETT sees its first graduation with Continuous Direct Compression (CDC) technology, we reassess where continuous manufacturing stands on the technology adoption cycle. Is this still a technology for innovators and early adopters, or are we making the steady move towards the early majority?

• How does this differ between small molecules, traditional mAbs and newer modalities?

• Top-down or bottom-up: which approaches for continuous processing adoption has produced the most impactful results in pharma?

• Quicker Speed to Approval, Speed to Market and Improved Product Quality – Too Good to Be True or a Reality Ready to be Adopted? A recent audit by the FDA shows applications that used continuous manufacturing were approved in a shorter time than the comparator batch applications, and the products using continuous manufacturing entered the market twelve months faster on average after regulatory submission, and three months faster after approval when compared to the batch applications. Is this due to increased communication with emerging technology team (ETT) prior to submission or genuine faster approval?

8:45 am Why Continuous? One Company’s Journey for Continuous Processing Adoption In-House

  • Raymond Knox Chief Manufacturing & Engineering Officer, Lyndra Therapeutics


• Changing attitudes from ‘why continuous’ to ‘why not continuous’?

• Stakeholder engagement to operator training, where are the pinch points for a top-down vs bottom-up approach?

• Technical vs strategic challenges – where is the biggest gap in industry capability today?

• Case study with timelines for bringing in-house continuous manufacturing (CM) line online

9:15 am Session Reserved for Continuus Pharmaceuticals

9:45 am From Unit Operation Implementation to End-to-End Strategy


  • Strategic and technical evaluation of end-to-end vs hybrid/unit operation approach for small molecule continuous manufacturing 
  • Where does each application bring the most value for the process and business? 
  • Our approach for integrated continuous trains and data from recent projects 



10:15 am
Speed Networking & Coffee

Small Molecules Track

Drug Substance Automation for Next-Gen Control

11:00 am Keeping a Flow Profile: Progress in the Automation & Optimization of Flow Chemistry


• Lab-scale flow process development is differentiated in

the ability to handle challenging chemistries and

scale robustly

• Combining automation with microfluidics enables

transformational optimization opportunities with minimal

material requirement

• Application of data-driven algorithms supports selfoptimization

methods with minimal human-in-the-loop


11:30 am Bright Path Laboratories – AI-Enabled Continuous Flow Manufacturing Platform Greener, Faster, Safer


• Bright Path Labs is disrupting the Pharma industry by

domestically manufacturing safe and affordable medicine.

• The current state of drug manufacturing in the US and

worldwide and the looming supply chain crisis.

• AI-enabled technology has a significant part to play in

solving the global pharmaceutical supply chain and safety


• The future of pharma has already arrived, and Bright Path

Labs is ahead of the curve.

12:00 pm Closed Loop Control in Continuous Drug Substance Manufacturing


• The goal: optimal operation in the face of disturbances

without manual attendance

• Use of PAT as well as online sampling and non-PAT

techniques (LC) in closed loop system

• Robustness is key: ensuring your closed loop control setup

is robust to measurement errors/artifacts and stable

across all visitable scenarios

12:30 pm Rapid and Flexible Continuous Process Scale-up for Clinical Batches

  • Olivier Dapremont Executive Director - Process Technologies, Ampac Fine Chemicals LLC


  • The challenge of developing continuous processes in a regulated environment
  • The approach of Continuous Process Development from a CMO perspective – CAPEX and time
  • Transition between proof of concept and the first GMP kilo produced using qualified equipment.
  • Process monitoring at different scales

Biologics Track

Moving towards End-to-End Continuous Bioprocessing

11:00 am Opportunistic Continuous Bioprocessing: Small Volume, High Potency Applications


• Where is continuous adding value to bioprocessing across

biologic portfolios?

• Program specific applications to maximize opportunities

for continuous bioprocessing

• Ensuring platforms and processes are in place to enable

adoption of continuous bioprocessing where appropriate

11:30 am End-to-End Continuous Biomanufacturing for Exosomes & Bionanoparticles


  • The supply of advanced medicinal therapies such as viral vectors and exosomes has been constrained by inadequate process and production technology. Over the years, Codiak has focused on process intensification and debottlenecking the production of exosomes to enable ample clinical supply while reducing cost of goods.
  • Through case studies based on successful process development, CODIAK Bio will describe the evolution of exosome manufacturing technology from batch to continuous and highlight further opportunities for integrated, continuous bioprocessing.

12:00 pm Advancing End-to-End Continuous Manufacturing for Biologics & Biosimilars 


  • CM implementation hurdles when moving from development to phase III manufacturing 
  • Regulatory assessment of CM
  • CoGs is the driver for CM of Biosimilars & Biologics

12:30 pm Secoya Emulsification Technology: a robust and versatile tool for the development of molecules encapsulation

  • Adrien Dewandre Tech leader & co-founder – Emulsification & Droplet Generation, Secoya Technologies


  • Why to use microfluidics to produce microcapsules ?
  • Development of a capillary based device for single and double emulsion
  • Detailed discussion on several practical case studies
  • Introduction to the Secoya Emulsification Platform

1:00 pm Lunch & Networking

Small Molecules Track

1:45 pm Execution of Continuous-by-First-Intent Portfolio With Commercial Examples


  • Ensuring infrastructure and capabilities for commercial continuous manufacturing 


Innovations in Continuous Drug Product for Efficient Workflows

2:15 pm Predictive Tools in Tablet Coating: Current and Future Development

  • Filip Willemse Scientist Drug Product Development, The Janssen Pharmaceutical


• Understanding tablet motion with particle simulations

• Case study: Optimising pan load for of film coating


• Transferring film coating from pilot to commercial scale


• Leveraging digital tools to increase process efficiency and

capability, improve product quality, reduce

2:45 pm Session Reserved for GEA

3:15 pm Continuous Personalized Drug Product Manufacturing using Drop-on-Demand Dropwise Additive Manufacturing


• Novel modular 3D printing platform using drop-on demand(DoD) technology for continuous manufacturing of various formulations is presented

• Specially designed PAT and control system enables reduced within dose and between dose variations

• A combined process and product design framework for the DoD system using machine learning is presented

• Integration with upstream drug substance process, and application to personalized and distributed drug product manufacturing is discussed

Biologics Track

Emerging Technologies for Downstream Innovation

1:45 pm Technology Implementation in GMP Stainless Steel Facilities

  • Divya Vasudevan Senior Engineer, Global MSAT & Engineering,, Genentech Inc

2:15 pm Scaling-Up Continuous Purification


• Continuous processing has made enormous strides in the biopharmaceutical industry over the past decade. In PAK’s own journey, technologies have moved from messy laboratory setups to out-of-the box, fully automated commercial offerings that run an end-to-end continuous biopharmaceutical process. As we look ahead, the company plans to scale up its systems to enable the manufacture of volumes not previously seen in the industry

• With these systems and facilities, we aim to be able to provide the world with biopharmaceutical products at rates that would enable vaccine inoculation of the world population in less than three months

• In this talk, we will explore the technologies that will enable this as well as the bottlenecks to global implementation of this network

2:30 pm Introduction to NIST, NIIMBL & Leveraging Private- Public Partnerships

  • Kelley Rogers Director & Chief Of Biosciences, Technical Program, Operations Division & Federal Program Manager, National Institute of Standards & Technology - NIST
  • John Schiel Technical Program Manager for NIIMBL, National Institute of Standards & Technology - NIST
  • Kelvin Lee NIIMBL institute director, NIIMBL


• What is the NIST strategy to ensure the biopharma industry can adopt emerging technologies in a timely manner with quality and cost in mind?

• Overview of how the government advancing continuous processing in pharma/biopharma industry, the role and model of NIIMBL and what successes and challenges have been seen on the journey so far? Roundtable Discussion. Audience to discuss:

1. How to ensure collaboration, connection and communication between quality and process development teams, why is this important?

2. How aware are you of the private-public partnerships in the US that can help your organization advance continuous?

3. What modalities still need more support? How can partnerships continue to help commercialize emerging technologies? e.g. Real time release

3:30 pm End of Biologics Track

3:45 pm Poster Session


Submit a poster to show case your latest work, and discuss your progress with a community of experts. See the website for more details on submitting a poster.

4:15 pm SMART Cycling and Advances in Protein A Chromatography Resins


• Jetting Technology

• Sustainability in Jetting

• Advances in Protein A Offerings: increased pH Elution

Regulatory CMC

4:45 pm Has the Publication of ICH Q13 Delivered the Global Regulatory Harmonization the Industry So Desperately Needs?


• Overview of regulatory and industry view

• Plans for Implementation training

• What are the next steps to ensure global harmonization, and what opportunities would this mean for the continuous manufacturing community?

5:15 pm Overview of the Regulatory Industry for Continuous Manufacturing

  • Moheb Nasr Principal, NPRC, Nasr Pharma Regulatory Consulting (NPRC)


• Industry perspective on the implementation of continuous manufacturing & related regulatory guidelines

• How does regulatory adoption and harmonization differ globally?

• What are the remaining challenges or regulatory gaps for both small molecule & biologic continuous manufacturing?

5:45 pm Chair’s Closing Remarks