Integrated Continuous Biomanufacturing VII
Final Program and Posters
Preliminary Program at a Glance
Session Descriptions
Product Quality Control through Integrated Continuous Biomanufacturing
Session Chairs:
Eva Gefroh, Just-Evotec Biologics, Inc
Sonja Berensmeier, Technische Universität München
As integrated continuous biomanufacturing (ICB) matures, ensuring robust product quality control remains a key process requirement. This session will explore case studies and strategies for maintaining product quality in an ICB process. Topics include process control strategies, utilization and implementation of Process Analytical Technologies, and the role of automation in actively managing product attributes. Additional themes include monitoring and mitigating process disturbances, segregation or diversion strategies, and leveraging material traceability and residence time distribution models for quality control. Regulatory considerations, comparability protocols from early to late-stage development and through scale-up, as well as approaches to lot definition and lot release in continuous manufacturing will also be considered. Attendees will gain insights into practical approaches for managing dynamic process conditions and ensuring consistent product quality.
ICB Large-Scale Implementation: Celebrating Achievements and Lessons Learned
Session Chairs:
David Garcia, Novartis
Weichang Zhou, WuXi Biologics
The complexity of biomanufacturing has increased over the last decade due to variable product demands, new product modalities, internal and CMO capacity constraints, and a constant need to be faster and more cost-effective. Integrated Continuous Biomanufacturing (ICB), and variations of it, have emerged as an alternative to traditional batch processes. Recently, there has been an increase in the adoption of ICB processes in the biopharmaceutical industry at non-GMP pilots scales, clinical and commercial manufacturing environments. This session aims to cover industry advances and lessons learned when implementing ICB into large-scale manufacturing operations and GMP implications. We encourage talks that share experiences during implementation, encountered challenges and the different approaches taken.
We strive to cover both strategic and real-world case studies with multi-disciplinary talks leveraging input from different functional areas such as process development, regulatory, non-GMP and GMP operations, supply chain, commercialization, validation, process automation, procurement and quality teams.
More specifically, we are seeking topics encompassing technical considerations for scale-up and scale-out (new technology tools for scaling and transfer), manufacturing experience (equipment and consumable designs), control and automation applications (including PAT strategies), facility design and constructions, or regulatory considerations (equipment and process validation, quality systems design and filing strategies).
Integrated Continuous Biomanufacturing for Emerging Modalities
Session Chairs:
Caryn Heldt, Michigan Technical University
Karol Lacki, Repligen
The scope of Integrated Continuous Biomanufacturing development continues to broaden from its roots in monoclonal antibody production to emerging modalities at an expanded rate. Advanced Therapy Medicinal Products (ATMP), such as viral vectors for gene therapy & gene editing, cell therapy, and nanomedicines such as mRNAs can still be considered as emerging biopharmaceutical products. The session will focus on Integrated Continuous Biomanufacturing (ICB) concepts as applied for production of ATMPs, nanomedicines, as well as other non-antibody formats (non-mRNA vaccines, antibody drug conjugates, extracellular vesicles), from several different perspectives; both theoretical and experimental contributions are encouraged. We look for contributions discussing the use of already proven ICB technologies as well as technologies specifically tailored for manufacturing of the emerging therapeutic modalities. Aspects such as quality, process economics, regulatory requirements, and market demand, to name just a few, are encouraged. In addition, the session also seeks to discuss ICB applications leveraging emerging hosts (e.g. microbial and plant systems) and/or emerging platforms (e.g. cultured meats and other novel bio-modalities) for biomanufacturing.
Digital (R)evolution for Integrated Continuous Biomanufacturing
Session Chairs:
Nuno Pinto, Merck & Co., Inc.
Maria Papathanasiou, Imperial College London
As bioprocesses transition into integrated and continuous systems, digitalization becomes crucial for enhancing system understanding, optimizing process control, increasing predictive capabilities, and fostering continuous improvement. The emergence of Industry 4.0 in the biopharmaceutical sector necessitates a robust digital infrastructure to support automation, real-time analytics, and effective management of process parameters. This session will explore mathematical models that encompass parts of or the complete process chain, bridging various scales and simulating operations to provide deeper insights and improved visibility during production. Additionally, we will examine the integration of Artificial Intelligence (AI) and Machine Learning (ML) to accelerate process development and refine process control, along with the application of soft sensors to bolster process robustness and reliability
Keeping Cells Continuous Happy – Strategies for Continuous Cell Culture Processes
Session Chairs:
Veronique Chotteau, KTH
Ken Lee, AstraZeneca
The biotech industry has progressed rapidly towards highly productive continuous cell culture, whether with dynamic perfusion or short- to mid-term steady state. This has been achieved through engineering strategies and novel technologies such as higher cell densities, better cell separation device, scale-down models, or via biological approaches, such as cell engineering and targeted integration. We are inviting presentations that aim to answer the following:
- How can the industry move towards higher productivity cell cultures and faster without compromising on product quality and safety?
- How can more product be continuously and sustainably separated towards DSP? Is filter-based cell separation still the answer?
- Which approach should be adopted to engineer or select the cells for continuous culture? Should cells for continuous process be different than for fed-batch and how?
- How can we streamline, simplify or intensify the logistics around liquid handling, i.e. medium and harvest, in continuous bioprocessing?
- How should we tackle the process robustness and regulatory challenges to increasing productivity and process duration? Are we now closer to a cliff? How can this be solved?
- Which strategy should be adopted for the process characterization? How should the scale-down model be defined?
ICB for Resolving Challenges in Continuous Downstream
Session Chairs:
Dong-Qiang Lin, Zhejiang University
Maarten Pennings, Biosana Pharma
Continuous downstream processing is essential for the successful implementation of ICB. This session will explore the latest advances in overcoming challenges in continuous downstream processing, with a particular focus on novel technologies and strategies that enhance process efficiency and address process dynamics. We invite presentations addressing the following topics: (1) Applications of continuous downstream that balance high selectivity with throughput, including techniques such as linear gradients, electrokinetics, and micro- and nanofluidics. (2) Novel approaches for process development and characterization of continuous processes, supporting interchangeability and technology transferability between batch and continuous. (3) Development of novel downstream unit operations or reconfiguration of existing technologies (precipitation, nanoparticles, fluidized beds, centrifugation) to achieve novel separations of product- or process-related impurities, remove or inactivate adventitious agents, or enable delivery of high concentration or novel formulations.
Workshop Descriptions
Debugging ICB – Next Generation Bioburden Control Upstream
Workshop Chairs:
Gene Schaefer, NIIMBL
Jason Walter, Sanofi
This workshop will focus on the critical aspect of microbial control strategies for ICB. Topics to discuss include: Segregation and quarantine strategies, rapid microbial testing approaches; over-testing and when to react to a positive signal; corrective action plans; root cause investigation tips and tools.
ICB Sustainability by Design
Workshop Chairs:
Magali Barbaroux, Sartorius
John Erikson, NIIMBL
In this session the strategies towards a circular bioeconomy will be discussed, including SU vs reuse, regulatory influence for reuse, technology to enable recycling, co-location of recycling technology with facilities, transportation, process design, intensification, closed system to reduce requirement for quality of air, reduction of floor space, waste reduction, ecofriendly raw materials, and also government and investors incentives. The workshop will start with an educational segment that reviews the latest bioprocess research in lifecycle analysis and circularity for plastics to set the stage for the second part where participants will discuss and debate prioritization of key areas. A short pre-conference survey will ask about current practice and barriers to implementation for implantation of reduction, reuse and recycling of the following key elements:
| Reduce | Reuse | Recycle | |
| Energy | |||
| Water | |||
| Medium | |||
| Buffers | |||
| Plastic bags, tubing | |||
| Resins/filters | |||
| Devices | |||
| Packaging (materials and medicine) | |||
| Transportation/supply chain |
The discussion will take into consideration the following:
- Local and national regulatory agencies, including transportation, EHS, waste management, and drug regulators.
- Employee and patient safety
- Cost
- To what extent we can collaborate with adjacent industries, e.g. food, hospitals, pharmacies, etc.
Upstream and Downstream Integration – Challenges and Opportunities
Workshop Chairs:
Andreas Castan, Cytiva
Riley Myers, NIIMBL
Continuous biomanufacturing has made major strides but one critical bottleneck remains: the interface between upstream and downstream. Even in well-designed systems, mismatched flow rates, impurity spikes, or pH and conductivity drifts can stall downstream performance and disrupt the entire process. In many cases, the handoff isn’t just a physical connection - it’s a poorly defined control point that needs more attention. This workshop puts that interface at the center. We’ll explore how to turn it from a vulnerability into a strategic advantage by defining critical parameters, embedding real-time analytics, and aligning process controls.
Key topics will include:
- Optimal sizing and strategic placement of surge vessels
- Residence time distribution (RTD) analysis
- Development and deployment of process-wide digital twins
- Implementation of feed-forward and feedback control strategies
- Standardization of data interfaces and communication protocols
- Modular process design
Join us to share your challenges, compare strategies, and shape the roadmap for truly connected continuous manufacturing. Whether you're running a pilot or implementing end-to-end ICB, you’ll find out what others are doing differently - and what you might be missing.
Optimal Facility Design for ICB
Workshop Chairs:
Hemanth Kaligotla, Lonza
Kevin Ingham, Just Evotec
Optimal Facility Design for ICB aims to equip attendees with actionable knowledge and strategic insights for designing, operating, retrofitting, and expanding Integrated Continuous Biomanufacturing (ICB) facilities. The workshop output will be a "Top-10" list of facility design principles as they relate to ICB to be published post-conference.
We will use interactive working sessions to explore the following topics:
- Key lessons from the first generation of ICB facilities —what has worked, what hasn’t, and why and the Insights will be applied to retrofitting existing facilities or building new ones.
- Use of modular strategies (e.g., PODs and portable skids/equipment) for ICB implementation and their practical challenges in layout, integration, and scale.
- Facility contamination control considerations for long-duration processes of ICB.
- Design enablers that improve process portability, reduce buffer/media prep burden, and eliminate equipment constraints.
- Impact of design decisions on Cost-of-Goods-Made (COGM), especially under uncertain pipeline and volume scenarios.
- Digital-first design principles: how can AI/ML can be embedded from the ground up and what level of building and process automation is required (eg MES/SCADA/ERP)
- Warehousing and infrastructure required for single-use heavy material management
- The impact of facility layout on the way teams get trained and collaborate.
The Value for Audience will be to confidently navigate the complexities of ICB facility projects-delivering facilities that are efficient, flexible, compliant, and ready for the future of biomanufacturing.
- First-hand insights from process scientists, engineers, and biomanufacturing leaders involved in designing and operating ICB-ready facilities.
- Practical case insights on how companies have dealt with multi-modality portfolios in these facilities
- Walk away with a practical checklist of design elements that enhance facility flexibility, operational simplicity, and scalability for next-gen ICB facility.
Disruptive Technologies for Disruptive Products
Workshop Chairs:
Linda Matthiason, Cytiva
Nihal Tugcu, Sanofi
Todd Przybycien, RPI
The participants in this workshop will explore the push and pull between disruptive products and disruptive manufacturing technologies - how cutting-edge biomanufacturing technologies are reshaping the development of next-generation biologics, how these biologics are driving the development of enabling biomanufacturing technologies, and the gaps/unmet needs in current and near-term biomanufacturing technologies. From innovative CDMO strategies to breakthrough Integrated Continuous Biomanufacturing (ICB) techniques, we will discuss the transformative potential of mRNA, ADCs, virus and other emerging modalities.
Example scenarios include:
- Harnessing the reduced residence times associated with continuous unit operations and processes to address inherently unstable products such as mRNA and enveloped virus.
- The use of “flow chemistry” to produce conjugates such as ADCs with narrow species distributions.
- The use of flow reactor configurations with immobilized enzymes for IVT to enable the efficient use and recycling of expensive catalysts and raw materials in the production of mRNA.
We aim for the group to share additional scenarios as well as insights into how disruptive technologies drive paradigm shifts — challenging legacy systems, enabling seamless integration, and fostering a start-from-scratch mindset for scalable, efficient production of new modalities.
We will focus the discussion by moving sequentially through a series of questions:
- Which modalities do we consider as disruptive modalities?
- What are the disruptive technologies on the horizon which support, enable or complement ICB?
- What are the manufacturing challenges associated with disruptive modalities?
- What are the ways these disruptive technologies can aid these disruptive modalities?
- Are we lacking any technologies to solve the challenges? What could they be?
- What would be our criteria for choosing the right technologies? Manufacturability?
Unlocking the Promise of Distributed MFG via ICB
Workshop chairs:
Kelvin Lee, NIIMBL
Scott Wheelwright, Biochromatographix
As the technology to perform ICB continues to mature, new opportunities to deploy ICB in a distributed network of manufacturing facilities becomes a reality. A more distributed manufacturing base would provide a more resilient supply and could allow companies to adjust supply to meet demand – being particularly helpful when demand forecasts do not accurately predict actual demand. However, to realize this future state of distributed manufacturing via ICB, our industry must overcome a number of barriers and address a number of important questions. While there may be lessons learned from other industries that have evolved distributed manufacturing networks, a number of issues may be unique to biopharmaceutical manufacturing and the workshop will be an opportunity to explore all of these issues in an engaging way.
Accordingly, this workshop will address key questions related to distributed manufacturing:
- What are drivers for a distributed manufacturing capability?
- What are some of the financial considerations and challenges?
- What are some of the regulatory considerations and challenges?
- What are some of the raw material and consumables supply chain considerations?
- What are key infrastructure considerations (workforce, power, water, etc.)?
- What are considerations around automation, PAT, and quality management systems?
For these topics (and others), we will aim to identify key benefits, drawbacks, and barriers to be breached. We hope to use the summary of the discussions to prepare a white paper that can be used to further the discussions within individual companies and across the biopharma industry.
Pre-conference Tutorials
Tutorial overview
The ICB conference series will, for the first time, offer pre-conference tutorials designed for newcomers to the field, providing a solid foundation in the principles and concepts of integrated continuous biomanufacturing. These tutorials will facilitate cross-functional learning and grant access to high-quality resources, including lecture notes and consolidated engineering fundamentals. Covering the design and scale-up of end-to-end processes, they also provide an overview of continuous chromatography and other often-overlooked continuous unit operations, equipping participants with essential knowledge for advancing in the field. Attendees of the pre-conference tutorials will also receive invitation to attend the ICB VII conference in its entirety.
To express interest in joining the pre-conference tutorials as well as the ICB VII conference, please complete this survey: by May 16th, 2025.
Design and operation of continuous chromatography
Instructor: Giorgio Carta, University of Virginia, Charlottesville, VA, USA
This tutorial will provide an overview of Multicolumn Chromatography (MCC) principles, advantages over batch chromatography, and applications in biopharmaceutical and bioprocess industries. Detailed explanation of key components, configuration, and theoretical analysis of continuous chromatography systems, including multicolumn capture chromatography and simulated moving bed chromatography (SMB), will be provided. With fundamentals in hand, strategies for designing continuous processes, including consideration of feed composition, flow rate gradients, resin properties, and separation targets will also be discussed.
Design and scale-up of upstream and end-to-end integrated processes
Instructor: Konstantin Konstantinov, Ring Therapeutics, Cambridge, MA, USA
This tutorial provides an in-depth exploration of two key elements of integrated continuous biomanufacturing: (1) upstream process development and scale-up and (2) integrated process workflows, emphasizing the importance of holistic design to achieve efficiency and sustainability from raw material input to final product. It covers fundamental process design principles, including material flow optimization and unit operation selection. Participants will learn effective scale-up strategies for transitioning upstream processes from lab-scale to industrial production, addressing challenges such as equipment design, process intensification, and maintaining product quality. Finally, case studies from various industries will illustrate successful end-to-end process implementations, providing practical insights and strategies for overcoming common challenges.
Non-Chromatographic unit operations for continuous biomanufacturing
Instructor: Alois Jungbauer, BOKU University, Vienna, Austria
This tutorial provides a comprehensive overview of unit operations tailored for continuous biomanufacturing, highlighting their role in enabling seamless, efficient, and scalable processes. Core topics include upstream operations such as continuous bioreactors and downstream techniques like continuous filtration, continuous virus filtration, continuous solid-liquid separation with various types of centrifuges, continuous micro/ultrafiltration and application of tubular reactors for non-chromatographic separation methods such as flocculation, precipitation and crystallization. Emphasis is placed on process integration, ensuring compatibility and synchronization between unit operations for end-to-end continuity. The tutorial concludes with case studies showcasing successful implementations of continuous biomanufacturing across diverse applications.
Abstract Submissions
Abstract Submissions are closed. Abstracts for all presentations will be made available to conference participants prior to the start of the conference.
Click here to see the status of your abstract.
Poster Guidelines
The best posters display a succinct statement of major conclusions at the beginning, followed by supporting text in later segments and a brief summary at the end. Click here for instructions and more information.
Poster Size: 1.0 meter wide and 1.5 meters in length (Portrait style).
Special Issues
Call for Papers
Deadline for submissions: 31st July 2026
Special Issue on Integrated Continuous Biomanufacturing in Biotechnology and Bioengineering
Integrated continuous biomanufacturing (ICB) creates opportunities to reduce manufacturing costs while enhancing flexibility and product quality. Impressive technological advances have been made over the past decade to enable the implementation of continuous bioprocessing, including advances related to Simplification, Emerging Therapeutic Modalities, Process Analytical Technology (PAT), Regulatory Science, Sustainability, as well as Modeling, Automation, and Control. Manuscripts describing successful implementation, applications of ICB to bionanoparticles, potential to modulate product quality leveraging ICB, advances in cell culture and high-resolution purification unit operations, as well as opportunities to leverage data science are welcome.
Through this Special Issue, we’ll seek to address key questions related to ICB technology development and adoption, including:
- How can we achieve an autonomous bioprocess with integrated continuous biomanufacturing?
- What are lessons learned from leading commercial-scale, GMP manufacturing implementations?
- How should we apply continuous biomanufacturing concepts for production of new and emerging modalities?
- What are the impacts on cost of goods, environmental footprint, process development approaches, and regulatory strategy?
- What role does process modeling and new concepts of process control leveraging machine learning, artificial intelligence and soft sensors play in advancing ICB?
Presented by:
Ana Azevedo, Instituto Superior Técnico (Portugal_
Kevin Brower, Sanofi (USA)
Mark Brower, Merck (USA)
Alois Jungbauer, BOKU (Austria)
Aaron Noyes, Apogee Therapeutics (USA)
Irina Ramos, Johnson & Johnson (USA)