Integrated Continuous Biomanufacturing VII
Session Descriptions
Product Quality Control through Integrated Continuous Biomanufacturing
Session Chair:
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.
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)