RXXI - Session Topics
Oral session 1: Process Mastery
Chairs:
Glen Bolton, Amgen
Angela Lewandowski, Bristol Myers Squibb
Nick Vecchiarello, University of Virginia
Process Mastery: Leaning into our Knowledge Base to Innovate Process Development
We have a deep knowledge base, built on over 40 years of large-scale production of recombinant insulin and monoclonal antibodies for therapeutic use. With a wealth of molecular and process development knowledge to lean on, we’re well-equipped to tackle emerging and challenging molecular formats and align intensified upstream processes with equally intensified downstream operations. But how are we cultivating this knowledge to advance novel formats and conquista even the toughest technical challenges? This session invites discussion from those ready to harness their molecular and process development data to solve these challenges and to create the future of process development.
Specific focus areas include:
• How have platforms failed us and how do we balance the benefits of consistent platforms versus cultivating innovation? How do we leverage and build upon our platform knowledge to address challenges with increasingly complex modalities?
• How do we leverage our knowledge and innovate to design more complex separations such as large shifts in charged species or glycans?
• How do we innovate for the removal of trace level host cell proteins that may be bound to or associated with the proteins of interest and be difficult to measure?
• With upstream titers reaching 15+ g/L in traditional fed batch and 30+ g/L in intensified batch, how do we innovate to attain facility fit as batches push well above 100 kgs?
• How can we leverage our prior and platform knowledge to progress towards in-silico and model-based process development and characterization?
This session aims to provide an appreciation and understanding of the wealth of knowledge that has grown across academia, small and large companies, regulatory agencies, and all geographical regions. This session will demonstrate how our process mastery is driving innovation and helping us deliver complex new medicines to patients.
Oral session 2: Digital Mastery
Chairs:
Andre Dumetz, GSK
Jennifer Pollard, Bristol Myers Squibb
Matthias Franzreb, Karlsruhe Institute of Technology
Digital Mastery: Leveraging Digital Tools to Accelerate Innovation in Process Development
Big data and Artificial Intelligence (AI) have revolutionized several industries in recent years. Following this trend, all major biopharmaceutical companies are currently undergoing a digitalization effort aimed at reshaping how to approach downstream process development. This session explores how novel digital tools using modelling, analytics, big data and AI are being applied to solve pressing challenges in the purification of complex biological products—from early development through scale-up and tech transfer, clinical and commercial manufacturing, to file authoring and submission, and finally through the life cycle of approved products.
This session will explore:
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How to build smart data strategies to ensure data quality and relevance, and avoid the pitfalls of Garbage In, Garbage Out (GIGO).
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The role of advanced data analytics in supporting efficient and insight-driven process development and process monitoring during manufacturing.
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Application of biophysical/molecular, mechanistic, and hybrid models to enable predictive, in-silico process development.
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Digital twins and AI agents supporting decision-making from early development to manufacturing.
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How machine learning, artificial intelligence, and large language models can accelerate workflows and decision-making.
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Case studies in facility fit and plant modelling that showcase digital strategies for robust and efficient tech transfer.
This session aims to provide practical insights and forward-looking strategies from leading industrial practitioners, tool developers, and academic experts. It is encouraged to cover both successes and failures, as well as to discuss organizational challenges encountered during the implementation of new digital tools. Join us to discover how digital mastery is not only enabling faster process development but also setting the stage for smarter, more flexible manufacturing operations.
Oral session 3: Transferable Learnings
Chairs:
Sanjeev Ahuja, Merck and Co., Inc.
Kelvin Lee, NIIMBL / University of Delaware
Andrew Maier, Genentech
Transferable Learnings: Drawing Inspiration from Beyond Biotherapeutic Downstream Processing
The evolving landscape of therapeutic formats demands innovations in downstream bioprocessing to ensure rapid, efficient, and high-quality development and manufacturing of biopharmaceuticals. While significant strides have been made, further improvements may be accelerated by leveraging insights and technologies from adjacent industries and non-biotherapeutic processes. This session will explore how cross-functional, cross-disciplinary, and cross-industry transferable learnings can serve as catalysts for novel solutions in downstream processing, addressing current challenges and fostering a new era of bioprocess innovation.
This session will explore:
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Novel High-Throughput Analytical Methods: Innovative, multiplexed, or high-throughput biophysical characterization (e.g., protein footprinting, proteomics, interactomics, drug discovery) to assess protein properties or predict manufacturability.
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Molecular and Process Engineering for Manufacturability: Modifications (process, sequence, or genetic) to enhance processability, improve stability, introduce purification handles, or reduce problematic host cell protein interactions.
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Advanced Harvest Technologies: Innovations in filtration and centrifugation (including and beyond traditional TFF/ATF) for challenging conditions (e.g., excessive fouling due to high cell density and suboptimal shear), drawing from other industries such as desalination, chemical industry, semiconductor manufacturing, or food processing.
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Cross-Industry Downstream Bioprocessing Learnings: Transferable insights from adjacent industries (e.g., enzymes, vaccines, diagnostics, small molecules, peptides, food/nutraceuticals, consumer products, or waste stream valorization).
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Enhanced Efficiency and Automation: Case studies demonstrating fully automated manufacturing and integrated analytics for feedback control and digital twins, from non-biotherapeutic sectors.
We invite researchers and practitioners to submit abstracts detailing scientific advancements and efficiency improvements that can inform and transform biotherapeutic downstream processing. This session provides a unique platform to share knowledge across industries and disciplines, leveraging diverse experiences to overcome current purification hurdles, drive future bioprocessing innovation, and enable production of the next generation of biotherapeutics.
Oral session 4: Back to Fundamentals
Chairs:
Julie Robinson, Merck and Co., Inc.
Alexei Voloshin, Solventum
Dorota Antos, Rzeszow University of Technology
Fundamentals as Inspiration for Innovation
As timelines shrink, pipelines diversify, and manufacturing facilities evolve towards greater agility, an advanced understanding of scientific and engineering principles – and their strategic applications is essential in modern downstream bioprocessing. From idea to implementation: Explorations and examples of the pursuit of a deep understanding of biophysical, physical, material science, colloidal, interfacial, transport, and thermodynamic phenomena in downstream processing environments that lead to innovations in separations media, equipment design, and process strategy are welcomed. How does the innovation address specific high value challenges, advance the current bioprocessing megatrends, and create new ones?
We welcome submissions that include but are not limited to:
· Design of novel filtration and chromatographic media informed by molecular-level understanding of biotherapeutic/stationary phase interactions
· New approaches that exploit novel separation principles and harness fundamental understanding of transport, colloidal, electrokinetic, or related physical phenomena
· New process strategies for building and operating separation processes that exploit the understanding of target, contaminants, and technology interactions
· New strategies for acceleration of purification development and improve process robustness
This session explores how fundamentals serve as the foundation for innovation. We invite talks that draw connection between fundamental understanding and purification challenges for consideration in this session.
Oral session 5: New Complexities
Chairs:
Stefano Menegatti, North Carolina State University
Rahul Sheth, BioMarin Pharmaceutical Inc.
Anne Kantardjieff, Biogen
New Complexities: Innovations in Process Development for Alternative Therapeutic Modalities
The next generation of biological medicines – including multi-specific antibodies, gene-editing nucleases, DNA and RNA-based modalities, viral vectors, and engineered cells – is rapidly transforming the landscape of modern therapeutics. With these advancements come unprecedented challenges in downstream bioprocessing, driven by increasing biomolecular and functional complexity. Purification technologies must now confront feedstocks with an increasing complexity of both product- and process-related impurities, while operating in a narrow range of process conditions to preserve biomolecular integrity and product functionality throughout the purification pipeline. This session invites abstracts that showcase innovative approaches and enabling technologies for the purification of advanced modalities.
We seek contributions that address the following themes:
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Flexible purification: strategies and tools that accommodate diverse product formats and host systems, while ensuring product integrity and activity as well as robust impurity clearance.
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Innovative ligands: development and application of affinity and mixed-mode ligands that expand molecular recognition and separation mechanisms for complex biotherapeutics.
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Advanced materials and media: design and implementation of next-generation materials, such as convective adsorbents, polymers, and hybrid substrates, that enable high-resolution, scalable, and sustainable Bioseparations.
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Robust and scalable GMP Production: Examples of successful transition from bench to at scale GMP production
Case studies demonstrating a quantum leap in product yield and critical quality attributes, integration with upstream or analytical workflows, and discussions on environmental sustainability and cost reduction, are highly valued.
Join us to share your breakthroughs and practical solutions that are shaping the future of bioseparations. This session offers a unique platform to connect with peers, exchange ideas, and contribute to making advanced medicines more accessible.
Oral session 6: Efficiency Enablers
Chairs:
Jeffrey Salm, Pfizer
Andrea Rayat, University College London
Gisela Ferreira, AstraZeneca
Efficiency Enablers: Seeding Next-Generation Capabilities to Catalyze Innovation in Bioprocess Development and Biomanufacturing
Advancements in bioprocess development and biomanufacturing have significantly improved efficiency, streamlined workflows, and enhanced process understanding, enabling optimized designs and manufacturing footprints. As we look to the future, integrating these innovations will be key to addressing emerging challenges such as developing complex molecular modalities, reducing costs, navigating diverse regulatory landscapes, and supporting personalized medicine.
This session invites you to envision the future of bioprocessing and biomanufacturing, where AI-driven processes, automation, high-throughput tools, and advanced monitoring redefine efficiency while maintaining impeccable quality. Attendees are encouraged to collaborate on strategies like zero development, sustainable manufacturing, and lights-out facilities to inspire new breakthroughs and shape the next decade of innovation.
Talks in this session will highlight current state and future vision for topics such as:
- Advances and applications of high throughput tools and automation
- Advanced biomanufacturing (Continuous and beyond; innovative modes of separation)
- Case studies in process analytical technologies and advanced process control
- Innovations in sustainability of biomanufacturing processes
- Novel raw materials and reagents that enhance bioprocess efficiency and robustness
- Tools and technologies that reduce regulatory risk and enable accelerated approvals
We welcome abstract submissions from champions of this future-focused strategy. Contributors are encouraged to share their vision for where we will be in 2036, identify and resolve critical paths, or open the horizons to new paradigms of how scientific knowledge is applied.
Poster Session
Chairs:
Caryn Heldt, Michigan Technological University
Andrew Tustian, Regeneron Pharmaceuticals
Simone Dimartino, University of Edinburgh
Poster Session: Innovation in the Recovery of Biological Products
Innovative work spanning the range of biotherapeutic downstream bioprocessing, including: innovation within and inspired by platform processes; the leveraging of digital tools; processes and approaches that draw on technologies outside of downstream processing and outside of biotherapeutics; an increase in the understanding of fundamentals; innovation driven by the complexities of new modalities; and the leveraging of efficiency-enhancing tools.