8:00 am Registration & Morning Refreshments
8:45 am Chair’s Opening Remarks
Where is Continuous Manufacturing Today?
9:00 am Key Opinion Leaders Panel: Emerging Technology to Maturing Capability, Where is Continuous in the Technology Adoption Life Cycle?
Synopsis
• 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?
9:45 am Why Continuous? One Company’s Journey for Continuous Processing Adoption In-House
Synopsis
• 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
10:15 am
Speed Networking & Coffee
Small Molecules Track
Drug Substance Automation for Next-Gen Control
11:30 am Keeping a Flow Profile: Progress in the Automation & Optimization of Flow Chemistry
Synopsis
• 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
intervention
12:00 pm Bright Path Laboratories – AI-Enabled Continuous Flow Manufacturing Platform Greener, Faster, Safer
Synopsis
• 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
problems.
• The future of pharma has already arrived, and Bright Path
Labs is ahead of the curve.
12:30 pm Closed Loop Control in Continuous Drug Substance Manufacturing
Synopsis
• 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
1:00 pm SK pharmteco needs to be added to talk ‘Flow Chemistry Platforms to Integrate Multiple Processes Using Flexible Systems – CDMO Perspective’
Biologics Track
Bioprocessing 4.0 for Upstream Innovation
11:30 am Opportunistic Continuous Bioprocessing: Small Volume, High Potency Applications
Synopsis
• 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
12:00 pm What is ‘Success’ for PAT in Continuous Bioprocessing?
Synopsis
• 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
12:30 pm End-to-End Continuous Biomanufacturing for Exosomes & Bionanoparticles
Synopsis
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.
1:00 pm Advancing End-to-End Continuous Manufacturing for Biologics & Biosimilars
Synopsis
- CM implementation hurdles when moving from development to phase III manufacturing
- Regulatory assessment of CM
- CoGs is the driver for CM of Biosimilars & Biologics
Regulatory CMC Track
Regulatory Harmonization for Global Adoption
11:30 am Has the Publication of ICH Q13 Delivered the Global Regulatory Harmonization the Industry So Desperately Needs?
Synopsis
• 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?
12:00 pm Overview of the Regulatory Industry for Continuous Manufacturing
Synopsis
• 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?
12:30 pm Control Strategy: Telling the Story
Synopsis
• Clearly communicating the control strategy utilization of raw material specifications, in-process tests, process monitoring and controls, and end-product testing
• What is must-include, and how to translate into a meaningful story?
1:00 pm Roundtable Discussion: Does ICH Q13 Leave Any Unanswered Questions?
Synopsis
Roundtables 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 Lunch & Networking
Small Molecules Track
Innovations in Continuous Drug Product for Efficient Workflows
2:30 pm Predictive Tools in Tablet Coating: Current and Future Development
Synopsis
• Understanding tablet motion with particle simulations
• Case study: Optimising pan load for of film coating
batches
• Transferring film coating from pilot to commercial scale
coaters
• Leveraging digital tools to increase process efficiency and
capability, improve product quality, reduce
3:00 pm Digital Solutions to Facilitate Adoption of Continuous Manufacturing
Synopsis
- 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
3:15 pm Continuous Personalized Drug Product Manufacturing using Drop-on-Demand Dropwise Additive Manufacturing
Synopsis
• 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
2:30 pm Scaling-Up Continuous Purification
Synopsis
• 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
2:45 pm Introduction to NIST, NIIMBL & Leveraging Private- Public Partnerships
Synopsis
• 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
Regulatory CMC Track
Collaboration & Communication for Commercial Success
2:30 pm Regulatory Reflections on Batch to Continuous Conversion
Synopsis
-Case study on batch to continuous conversion when were regulatory teams engaged and what challenges were presented
-How to ensure proper communication and collaboration between development, commercial, internal, and external regulatory teams
-Integration of real time release testing; what are the implications from regulatory perspective?
3:00 pm Panel Discussion:Quicker Speed to Approval, Speed to Market and Improved Product Quality – Too Good to Be True or a Reality Ready to be Adopted?
Synopsis
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?
• What are the regulatory concerns for companies new to the commercial manufacturing commercial space?
3:45 pm Poster Session
Synopsis
Submit a poster to show case your latest work, and potentially get the opportunity to present your work onstage amongst the expert
speaker faculty. See the website for more details on submitting a poster.
4:15 pm SMART Cycling and Advances in Protein A Chromatography Resins
Synopsis
• Jetting Technology
• Sustainability in Jetting
• Advances in Protein A Offerings: increased pH Elution
Is End-to-End the Be All & End All?
4:45 pm From Unit Operation Implementation to End-to-End Strategy
Synopsis
• 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