Agenda
Basel, 30 September 2025 - 2 October 2025
Schedule
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Chair's opening remarks
Achieving Sustainability in the Biologics Market
WuXi XDC: Novel Conjugation and Payload-linker Technologies to Empower Next-generation ADCs
1. WuXiDARx (x= 1, 2, 4, 6) conjunction technologies enable highly homogeneous ADCs without engineering mAbs or applying enzymes, achieving D1 > 90% using WuXiDAR1, D2 > 95% using WuXiDAR2, D4 > 70% - 85% using WuXiDAR4, and D6 > 80% using WuXiDAR6.
2. Application of WuXiDARx beyond traditional ADCs :
DAR1 AOC without engineering mAbs
Dual-payload ADCs with flexible formats(4+4; 2+4; 2+6) using traditional payload-linkers.
3. WuXiTecan-1 and WuXiTecan-2, the proprietary payload-linker (PL) technologies of WuXi XDC, enable next-generation ADCs with a wider therapeutic window, which is crucial for improving the efficacy and safety of ADCs.
The Digital Advantage
Antibody-based product successes and progresses in 2024
Biosimilars Development 2025 and Beyond: Coming Full Circle
Biosimilar streamlined development: returning to the roots of the “stepwise approach”
Paradigm of medicinal chemistry: structure determines function (not the other way around)
What we knew all along, but were hesitant to accept: analytics tell the story well (the clinic need not)
Why differential immunogenicity was never the problem it was made out to be.
Moving the adoption needle, bit by bit, step by step (working together to succeed together)
The biosimilar future: purposefully fit, fit for purpose (the beginning of a new era)
Biosimilars Late Stage Development: Back to the Future
Bringing Medicine Development to patients, the why and the how
Systems biology approaches in improving quality and titer of biologics
Accelerated and Robust Cell Line Development in HEK293 Cells for Increased Protein Yields and Improved Protein Quality
Senior Representative, ExcellGene
KojoX - A Transformative Operational Ecosystem Delivering Flexible Manufacturing Strategies and Security of Supply
Leveraging Biologics manufacturing capacity for supply of life impacting or saving medicine is the key to a flexible supply chain that can respond to unforeseen demand changes. FUJIFILM Biotechnologies’ kojoX™ operational ecosystem is transforming the CDMO industry, delivering across a globally harmonized network and over a range of scales. KojoX is founded on using standardized infrastructure and processes to enable rapid transfer and production of medicines across one global network. However, the constantly evolving landscape driven by scientific and technological advances requires flexibility within this kojoX framework.
The presentation will outline the tools and strategies Fujifilm deploy to integrate current ways of working with innovation activities to ensure future technical solutions and processing strategies can be effectively and efficiently deployed into the kojoX ecosystem to solve today’s challenges as well as future patient needs.
Genetic engineering strategies to eliminate lactate production and control ammonia secretion
Accelerating the Development and Manufacturing of Biologics
Biomarkers in clinical trials and clinical practice – why one biomarker is usually not enough
Biosimilars Keynote Panel
Optimising poloxamer 188 for CHO and HEK suspension cells for reduced batch-to-batch variation
The bioprocessing industry utilises Poloxamer 188 as a surfactant in parenteral biological formulations and as a shear stress protectant in cell culture. Poloxamer 188 is a non-ionic block copolymer with a hydrophobic polypropylene oxide (PPO) chain that is flanked by two hydrophilic polyethylene oxide (PEO) blocks. This unique molecular arrangement enables it to significantly reduce cell shear stress, which is essential for maintaining cell viability and overall health—a vital component in the successful production of biomolecules. However, the presence of impurities introduced during the manufacturing process can negatively compromise the functionality of Poloxamer 188 and adversely affect cell health, contributing to inconsistencies in performance between different production batches. Therefore, this inconsistency presents a persistent challenge in the bioprocessing market. As the demand for high-performance, batch-consistent cell culture ingredients continues to grow, Croda Pharma recently introduced Super Refined™ Poloxamer 188. Specifically optimised for cell culture, Super Refined™ Poloxamer 188 delivers excellent performance with tightly controlled impurity profiles, thereby reducing the risk of variable cell performance across different batches. To validate the efficacy of this innovative product, in this study we showed its exceptional performance in cell viability in both Chinese Hamster Ovary (CHO) and Human Embryonic Kidney (HEK) suspension lines. Furthermore, our study provides robust data that emphasises the batch-to-batch consistency of Super Refined™ Poloxamer 188, along with comprehensive analytical information that details its composition and impurity profile. As the need for reliability and batch-to-batch consistency of bioprocessing materials becomes increasingly evident, we believe Super Refined™ Poloxamer 188 will prove to be an exciting solution in this field.
Protecting healthy volunteers in clinical trial - The VolREthics initiative.
Healthy volunteersplay a vital role in advancing science and medicine through their participation in research studies. Their contribution is especially well recognized in the early stages of medicinal product development and pharmacokinetic studies. However, their motivations, the risks they face, and the ethical issues involved can vary significantly depending on the context. The Global Charter developed by the VOLRETHICS initiative seeks to strengthen the protection of healthy volunteers, particularly in relation to the risks of harm, exploitation, and compromised well-being.
Automated bioinformatics pipelines for rapid in silico analysis – In silico antibody assessment selection
Senior Representative, PipeBio, a Benchling Company
The critical role of the 5,000 L bioreactor: Bridging drug substance supply needs between early and late-stage development
Senior Representative, Thermo Fisher Scientific
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Senior Representative, Seromyx
Biosimilars- An update from the UK
BiXAb MAIT engagers: redirecting an abundant cytotoxic T-cell subset to control solid tumors.
BPT567 (PD1-IL18) induces potent anti-tumor immune responses by targeting IL-18BP-resistant IL-18 to PD-1+ T cells in the tumor microenvironment
Developability and risk-based control strategies of antibodies and ADCs
Developability and risk-based control strategies of antibodies and ADCs
Discovery, development and manufacturing of optimized biologics using engineered CHO cells.
From In Vitro Discovery to Modular Protein-Protein-Conjugation: Combinatorial Assembly of Bispecific Antibodies
Patient and Public Involvement in clinical studies. The importance of the contribution of a Patient Advisory Board
Promises and Challenges of Invio CAR - T therapies
Stimulating collaborations across the ecosystem to advance the impact of cutting-edge patient treatments
- The importance of innovation ecosystems to advance research into real-world applications
- How to stimulate collaborations in deep tech for patient treatments
- Building strong and resilient innovation ecosystems
The Impact of Tissue Biopsy in Clinical Trials
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Treating Solid Tumors
Clinical application of HLA peptidomics for precision immunotherapy
Cyto-Mine® Chroma: A multi-laser droplet microfluidics platform to accelerate clonal selection during therapeutic development
Sphere Bio’s Cyto-Mine® Chroma advances antibody discovery and cell line development with droplet microfluidics & multi-laser single-cell analysis. Leveraging picodroplet technology, it enables high-throughput screening of cells of interest, accurately sorting and dispensing single cells by productivity & viability, accelerating therapeutic development.
In this talk we will introduce Cyto-Mine® Chroma, highlight its multiplexing capabilities, present applications and assays for use with the platform, and have a look at the road ahead.
Engineering Antibody-Cytokine Fusion Proteins (Immunocytokines) for Cancer Therapy
- Immunocytokines can increase the therapeutic index of the cytokine payload
- Immunocytokines can selectively localize at the tumor site
- Immunocytokines can induce potent anticancer activity either alone or in combination with other immunomodulatory drugs
Enhanced vector technology for improved expression control of bispecific antibodies
Senior Representative Lonza
Introducing a novel peptide linker technology for the direct modification of antibodies
STAb-T Immunotherapies: Novel Delivery Strategies for Bispecific T Cell Engagers in Cancer
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Senior Representative, Specifica, an Iqvia Company
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Senior Representative, Nanotemper
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Senior Representative, Genovac Antibody Discovery
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A critical look at acid-catalyzed deamidation, peptide solubility and other challenges in conventional Multi-Attribute Method (MAM) workflows – potential pitfalls and solutions
Bridging Science and Policy: Regulatory Pathways for Biosimilars in Emerging Markets
- Explore the evolving regulatory frameworks for biosimilars in emerging markets, with a focus on harmonization and local adaptation.
- Highlight the scientific, technical, and policy challenges that shape regulatory decision-making.
- Share lessons learned and success stories from the Iraqi and MENA region experience to illustrate practical approaches to accelerating biosimilar access.
Cytokine-based precision therapeutics addressing todays unmet medical needs in infectious diseases, oncology and autoimmunity
Improving ADC development: high-throughput and in-depth characterization of ADCs by high-resolution mass spectrometry
Antibody-drug conjugates (ADCs) are targeted biopharmaceuticals that combine potent cytotoxic drugs with highly selective monoclonal antibodies to deliver chemotherapy specifically to cancer cells, reducing damage to healthy tissue and minimizing side effects. This allows for higher drug doses and increased efficacy. However, ADCs with lysine or cysteine conjugation sites are highly heterogeneous, making their characterization challenging. Determining conjugation sites accurately is key to effective targeting. The drug-to-antibody ratio (DAR) also impacts efficacy, safety, and therapeutic potential. High-resolution mass spectrometry is essential for characterizing ADCs, providing data on conjugation sites, molecular weight, stability, and impurities, and aiding in optimization and quality control.
In the present study, we have developed two analytical workflows for the characterization of ADCs:
1. High-Throughput SEC-MS Workflow: This approach operates under native conditions, enabling rapid analysis of drug load distribution and DAR via fully automated data processing.
2. High-Resolution RPLC-MS/MS Workflow: This method facilitates precise determination of conjugation sites, quantification of site occupancy, and analysis of other post-translational modifications.
In a forced degradation analysis, we demonstrated that exposure to elevated temperature stress significantly impairs both the DAR and the conjugation site, highlighting the vulnerability of ADCs under stress conditions. In addition to the detailed assessment of conjugation site occupancy, we were also able to identify and quantify several critical quality attributes (CQA) of the antibodies, including several deamidation and oxidation sites. These results provide valuable insights into the stability and integrity of ADCs and emphasize the importance of stringent quality control in the development process.
With our approach, we show that these analytical workflows are very well suited for both high-throughput and comprehensive characterization of lysine- and cysteine-conjugated ADCs and can be transferred to ADCs with other conjugation strategies. In general, this approach can be used in the development process of ADCs for the comparison of production batches, stability studies and forced degradation analyses for quality control and assurance.
Repolarization and redirection of macrophages for tumor eradication
Robust bispecific antibodies through fusion of single-domain antibodies on IgG scaffolds
Therapeutic Antibodies: Rewiring Macrophages in the Tumor Microenvironment
As one of the most abundant immune cells in solid tumors, tumor-associated macrophages (TAMs) are characterized as high plasticity with both pro- and anti-tumor functions, depending on the microenvironment. On one hand, TAMs are capable of engulfing dying tumor cells, leading to the clearance of associated tumor antigens, which helps the tumor to escape the host immune surveillance. TAMs also secret immune-suppressive cytokines that maintain a pro-tumor microenvironment. Consequently, TAMs contribute to the resistance of checkpoint inhibitors, chemo/radio-therapeutic agents, and adoptive T cell immunotherapies in clinic. Alternatively, when TAMs are properly activated, they destroy live cancer cells or other immunosuppressive cells, acting as a defensive mechanism against tumors by killing them directly and indirectly. Thus, modulation of TAMs functions represents an attractive approach for cancer immunotherapy. Here, we share two case studies to exemplify that antibody drugs enhance cancer immunotherapy by modulating macrophage functions. First, we established a real-time, live cell imaging-based phagocytosis method that is fully automated with high throughput capability and less disturbance to macrophages. By using our established phagocytosis assay, we discovered potent anti-MerTK monoclonal antibodies (mAbs) that inhibit macrophage-mediated phagocytosis of apoptotic cancer cells both in vitro and in vivo. Dosing of anti-MerTK mAbs in a syngeneic mouse tumor model resulted in robust anti-tumor responses when combined with the checkpoint inhibitors anti-PD1/PD-L1. Leveraging our advanced imaged-based antibody-dependent cellular phagocytosis (ADCP) assay, we discovered a novel mAb with enhanced ADCP mediated by macrophages. This mAb uniquely targets and efficiently depletes tumor-infiltrating regulatory T (Treg) cells, a critical population of immune-suppressive cells in the tumor microenvironment. This constitutes another promising strategy for targeting the immunosuppressive tumor microenvironment. Besides drug discovery, our established imaged-based phagocytosis methods have broad applicability to dissect the kinetics and molecular mechanisms of cellular phagocytosis.
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Circular DNA, Circular Economy: Redefining Critical Quality Attributes for Sustainable Plasmid DNA Manufacturing
Clinical Data Management in Rare Diseases
Development and Dissemination of affordable cell based immunotherapies for low income countries
Developments at Phenomic
Human Antibody Discovery and Engineering: The Adimab Way
This presentation will explore how Adimab has revolutionized therapeutic antibody discovery, growing from an innovative startup into a leading platform technology company. We will examine key technological breakthroughs in our platform development, focusing on synthetic antibody library evolution, advances in multispecific antibody generation, and novel approaches to antibody developability optimization. Through specific examples, we will demonstrate how our engineering solutions have enhanced therapeutic candidates and improved their potential for success. Join us to learn how Adimab's systematic, engineering-driven approach is shaping the future of antibody therapeutics.
Innovative Approaches in Cell Line Development: Leveraging Technology and Case Studies for Scalable Process Optimization
Senior Representative Lonza
Leveraging the integrated ATUM platform for improved manufacturability of next-generation biologics
ATUM leverages its integrated gene design, synthesis, protein engineering, and cell line development platforms to accelerate the discovery, optimization, and manufacturing of bispecific antibodies. The platform enables rapid prototyping and functional screening of diverse bispecific formats. This talk will highlight case studies demonstrating how ATUM’s platform facilitates the efficient development of bispecific antibodies.
Regulatory Harmonization for Biosimilars: Global Challenges and Opportunities
- The role of clinical studies in biosimilar approval.
- Variability in biosimilar regulations across different regions and its impact on development.
- Opportunities for regulatory alignment to streamline approval processes and global access.
- Addressing challenges in pharmacovigilance and post-approval requirements for biosimilars.
The Tubutecan Platform – Technology Enabled Payload Solutions Targeting Topoisomerase-I: Preclinical Data for Solid Tumor Targeting ADC Candidates TUB-030 and TUB-040
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A next generation ADC for Nectin-4 expressing tumors: preclinical characterization of IPH45, a novel and differentiated exatecan-based ADC targeting Nectin-4
ANV700: A Proximity-Activated IL-21 Therapeutic Targeting PD-1+ Tumor Infiltrating Lymphocytes
- Targeted IL-21 delivery:ANV700 is a Proximity-Activated Cytokine (PAC) that selectively delivers IL-21 to PD-1+ tumor-antigen specific T cells, maintaining strong IL-21 signaling in PD-1+ cells while minimizing off-target activation and systemic toxicity.
- Enhanced Tumor-Specific CD8 T Cell Activity: In mouse tumor models, ANV700 surrogate compound treatment leads to tumor growth retardation by increasing the number and functionality of tumor antigen-specific CD8 T cells.
- Synergistic Therapeutic Potential:ANV700 synergizes with PD-1 checkpoint inhibitors and PD-1-targeted IL-2Rβγ agonists, combining proliferative and reinvigorating effects for a durable anti-tumor response, supporting its development as a monotherapy or combination therapy.
Generating potent CAR T-cells for targeting solid tumours
Sane in the membrane - Discovery of antibodies against challenging membrane protein targets using Salipro nanoparticles
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Precision controlled biomanufacturing using off the shelf, ready-to-use components: from bench to clinic
Precision-controlled biomanufacturing, cell processing tools, and particle separation technologies are pivotal in the production of Advanced Therapy Medicinal Products (ATMPs), synthetically cultured biologics, and laboratory-grown food. As the demand for efficient, consistent, high-performance, and scalable manufacturing solutions intensifies, adaptable downstream cell processing platforms have become essential. Single-use systems offer a promising solution by providing operational simplification, reduced cross-contamination risks, flexibility, and minimal downtime. Nevertheless, the validation of these systems remains a critical concern, necessitating assurance of consistent performance, material compatibility, integrity, sterility, and regulatory compliance.
This session will present data from the development of a ready-to-use, sterile plug-and-play assembly designed to streamline critical processes such as cryo-preservation, cell banking, mammalian cell growth, separation, filling, and storage applications. We will also explore key validation considerations for single-use systems, highlighting the challenges and risks associated with transitioning from traditional aseptic technologies to innovative alternatives like the featured plug-and-play assembly.
Attendees will gain valuable insights into cutting-edge systems utilized across the life sciences and the meticulous steps required for their successful validation
Vytal®: The ready-to-use snap-fit system for container closure solutions, setting the standard for the future.
In recent decades, the landscape of parenteral drug production has undergone significant transformation, driven by the emergence of novel molecules and advanced therapies. The pharmaceutical industry has witnessed a notable shift towards biologics, mAbs, and cell-based therapies, which now represent some of the most successful pharmaceutical products globally.
The production of biotherapeutics presents unique challenges due to their inherent instability and specific containment requirements. This has necessitated a fundamental reimagining of manufacturing processes, with aseptic filling becoming essential in modern pharmaceutical production.
Vytal®, an innovative RTU snap-fit closure is specifically designed for small to medium-batch production of advanced therapeutics, including biologics, viral vectors, mRNA, antibody-drug conjugates, cell & gene therapies and orphan drugs.
Developed under ISO13485 and GMP Annex I requirements, Vytal® offers:
· Snap-fit system
· Ready-to-use
· Glass & COP vial compatibility
· CCI assured even at low temperature (-80 °C)
· Compatibility with standard marketed CSTDs
· ISO dimensions
· Nested & Bulk
· Full visibility
· Reduced particle generation
· Low residual volume
· Anti-counterfeiting: Tamper-evident features & laser marking
Vytal® helps pharmaceutical companies accelerate time-to-market while maintaining high-quality standards, meeting the demands of modern filling technologies and competitive market pressures.
Benefit risk framework for regulatory decision next steps
Beyond the Protocol: Key Steps for a Successful and Timely First Clinical Trial
- Quality Management System: Implement robust processes to ensure consistency and compliance
- Clear Project Management: Align timelines and budget from planning through execution
- Strategic Framework: Define trial objectives, resources, and collaboration essentials for success
Engineering human cytokines for therapy
Engineering of bispecific antibody-based IL-12 mimetics with biased agonism capacities
Engineering of bispecific antibody-based IL-12 mimetics with biased agonism capacities
Harnessing IgA for Cancer Therapy: A Local Production Approach with Tumor-On-Chip and In Vivo Validation
Streamlining M-gager Development: From CHO Pool to Process Lock
CDR-Life is transforming the treatment of cancer and autoimmune diseases with its proprietary M-gager® T cell engager format, enabling highly selective targeting of both conventional and previously difficult-to-addressantigens. Our integrated, end-to-end development approach accelerates the creation of promising drugs against challenging targets. This is achieved through synergistic, multidisciplinary collaboration across the discovery, pharmacology, preclinical, and technical development functions at CDR-Life. To streamline process development toward clinical manufacturing, our CMC team leverages a strong partnershipwith a cell line developer for synchronized CHO cell line and upstream process development. Our established M-gager® platform process facilitates efficient process development starting with stable pools, enabling the production of representative material for animal and preclinical safety studies at an early stage. We reduce risks and ensure smooth, timely tech transfers by aligning clone selection and process optimization with both the cell line provider and the CDMO. Our integrated approach supports rapid development and scalable manufacturing, positioning CDR-Life to deliver transformative immunotherapies to patients with high unmet needs
The Therapeutic Potential of IgE and IgE-derived Antibodies
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Senior Representative, Tubulis
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Senior Representative, ABSCI
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Senior Representative, Lightcast
Antibody-Cytokine Fusions for Cancer Therapy: Late-Stage Clinical Results
- Cytokines are modulators of the immune system that can be used for cancer therapy
- Cytokines can be anchored to the TME by means of antibody delivery
- Combinations of tumor-targeted cytokines can elicit a potent, synergistic anti-cancer activity
Bifunctional antibody derivatives for immune system manipulation
- Generation and characterization of single-domain antibody derived bispecifics
- Mimicking the function of a cytokine by triggering agonism on its receptor
- Antibody engineering to further improve the agonism
Bifunctional antibody derivatives for immune system manipulation
Disrupting Peptide Therapeutics: Numaferm’s Numaswitch Platform for Sustainable, Scalable, and Scarless GLP-1 Analog Manufacturing
The demand for high-purity, scalable, and cost-effective production of GLP-1 receptor agonists and related peptide therapeutics continues to rise—yet traditional synthesis approaches remain constrained by sustainability, scalability, and cost limitations. Christian Schwarz, PhD, Founder and CSO of Numaferm GmbH, introduces a new paradigm in peptein manufacturing with theNumaswitch platform: a fully biotechnological production system enabling thetraceless, efficient, and sustainable manufacture of native peptides and proteins.
At the core of this platform isNumacut, a proprietary protease engineered to cleave after nearly all amino acids (except proline), enabling scarless removal of fusion tags and overcoming a longstanding limitation of conventional sequence-specific proteases like TEV. In tandem with Numaferm’sSwitchtag technology, this platform allows seamless integration ofnon-canonical amino acids, high-purity expression, and simplified downstream processing.
Numaswitch offersproduction timelines of less than 2 weeks,scalability to 100 kg per campaign, and isfree from toxic solvents, TFA, and non-sustainable reagents. Compared to traditional chemical synthesis, it deliversCO₂ footprint savings exceeding 90%andcost-of-goods reductions of over 85%, meeting increasing regulatory and environmental expectations.
These capabilities make Numaswitch a compelling solution for next-generation GLP-1 analogs, where molecular complexity, sustainability, and time-to-market are critical. Real-world applications will be discussed, highlighting how Numaferm's innovations translate intosecure supply chains,lower environmental impact, andtransformative economicsfor advanced peptide-based therapeutics.
Navigating regulatory success for Biologics: why early establishment of a Quality System is essential
TCR-Specific Engagers that Selectively Target IL-2 to Tumor-Specific T Cells
The Path to Enlightenment: Strategic Photostability Testing & Light Mapping in Fill & Finish Operations
- Photostability Studies in CMC Development: Strategic implementation of forced degradation and confirmatory photostability testing at critical development milestones to identify light-sensitive products and establish appropriate protection requirements.
- Comprehensive Light Mapping Methodology: Systematic approach to quantify light exposure across fill and finish operations, focusing on critical processing areas where product is most vulnerable to photodegradation.
- Risk Mitigation Strategies: Development of effective light protection measures based on photostability data and light mapping results, including facility modifications, process adjustments, and monitoring protocols.
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Senior Representative, BSP Pharmaceuticals
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Directed Luck®: Transposase targeting and Transposon design push expression beyond limits
Transposases have eased cell line development. Taking this concept to a new level, we equipped our hyperactive transposase with epigenetic readers that targets highly active genomic sites in the host cell line and designed advanced transposons with optimized ITRs for most efficient and clean integration. DirectedLuck® delivers highly productive clones and bulk pools ready for manufacturing and is particularly suited for heterodimeric formats, polyclonal antibody cell lines and viral vector packaging cell lines.
Leveraging a toolbox approach to enhance cell line development for multi-specific molecules
In recent years, the emergence of more complex biologics has been driven by the need to address diverse disease indications. These novel molecule formats including multi- and bispecific antibody formats, present challenges for standardized cell line development platforms. To overcome these challenges, both innovative technologies and highly customizable strategies are essential for creating optimal cell lines for manufacturing. At Sartorius, we have adopted a toolbox approach and combined it with automation and predictive modeling to achieve optimal titer and product quality profile. In this talk, we will expand on how this highly adaptable framework enables us to develop optimal cell lines for multi- and bispecifics and push the boundaries of non-standard antibody formats.
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Senior Representative, Bio-Rad
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Senior Representative, Catalent
Unveiling the PanCancer potential of dual-mechanistic uPAR-targeting ADCs across cancers
Currently, most approved antibody-drug conjugates (ADCs) target tumor-associated antigens. However, this approach hinders effective treatment of solid tumors, particularly those with a dense stromal microenvironment, like pancreatic cancer (PDAC), where the tumor stroma contributes to disease progression, immunosuppression, and drug resistance. To address this challenge, we have developed PanTarg, a novel ADC designed to target both cancer cells and the surrounding stromal environment. PanTarg specifically targets the urokinase plasminogen activator receptor (uPAR), which is overexpressed in both the tumor and stromal compartments of many aggressive cancers, particularly PDAC, with limited expression in normal tissues. This dual-target strategy aims to overcome stromal barriers and expand the range of indications and patient populations that can benefit from ADCs. PanTarg is based on a proprietary uPAR antibody with optimal ADC properties. In preclinical models of PDAC and other uPAR-positive tumors, PanTarg has demonstrated strong anti-tumor and stromal effects, bystander and immune modulatory activities, and good tolerability. These promising results validate uPAR as a compelling ADC target and position PanTarg as a potential new therapeutic option, either as a monotherapy or in combination therapies.
Amanitin-based ADCs Overcome Resistance in Cancer Patients
Developability and manufacturability considerations for next-generation biologics
Next-generation antibodies, including bispecifics and multispecifics, offer unique therapeutic applications in various human diseases. However, in order to do so, their deviations from traditional monoclonal antibody structures also present developability and manufacturability challenges. We will discuss our latest work on the developability assessment, such as the polyreactivity and aggregation propensity properties of various next-generation biologic candidates, in the overall aim of driving their rational development and optimization towards therapeutic success.
Developing Avidity-driven Tumour Selective Multispecific Antibodies
eIg-based bispecific T-cell engager: Format matters
Enhancing Cancer Immunotherapy by Targeting Cancer-Associated Glycans
- Immune checkpoint inhibitors have led to long-term remission in some cancer patients, but the majority still do not benefit from current immunotherapies.
- Targeting cancer-associated glycans—via glycan-specific antibodies, CARs, and bispecific antibodies—offers a promising strategy to overcome resistance to current treatments.
- Modifying the tumor microenvironment through glycan-engineering using enzymes or small molecules has shown enhanced efficacy in preclinical models, with early clinical trials now underway.
NANOBODY® VHH as a modality for Targeted Protein Degradation
Sustainability in Clinical Operations
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Accelerate antibody variant screening and development
Biotherapeutics is the fastest growing sector in the pharmaceutical industry.While the market is still largely dominated by monoclonal antibodies (mAbs), a growing number of non-traditional antibody formats are driving increased molecular diversity. These new formats offer advantages like dual targeting, better tissue penetration, and the ability to cross the blood-brain barrier. However, their structural complexity introduces new challenges in purification, analytics, and manufacturing. Traditional mAb purification relies on platform methods using affinity resins like Protein A. For novel antibody formats, customized solutions are needed, and in this presentation, we will introduce new chromatography resins like MabSelect™ VH3 and MabSelect™ Mild Elution, designed to meet these evolving needs. As the biologics pipeline expands, the demand for robust, high-resolution analytics grows. Biacore™ systems provide detailed insights into titer, potency, binding kinetics, and epitope specificity across a wide range of molecule types. In this presentation we will show how selecting antibodies based on developability, efficacy, and safety is key to successful CMC progression. Case studies will include epitope binning, clone selection, bispecificity assessment, and thermal stability testing under physiological conditions. We will close by briefly mentioning PrismA ELISA™ kit, specifically designed for detecting residual PrismA protein A ligand from chromatography resins.
Advancing Therapeutic Oligonucleotide Manufacturing: Oligo Factory’s GMP Solutions for Clinical Success
The increasing demand for high-quality oligonucleotides in therapeutic applications necessitates scalable, efficient, and compliant manufacturing processes. Oligo Factory is at the forefront of this demand, offering ICH Q7 GMP-compliant oligonucleotide manufacturing with a focus on therapeutic oligonucleotides such as ASOs, siRNA, aptamers, and guide RNAs. This presentation will highlight Oligo Factory’s proprietary synthesis platform, scalable production capabilities, and comprehensive analytical services designed to meet rigorous regulatory standards.
Attendees will gain insights into how our U.S.-based and sourced GMP facility streamlines oligonucleotide manufacturing, ensuring the highest quality, rapid turnaround times, and flexible support from late discovery through clinical phases. In addition, we will explain our key process optimizations that enhance efficiency and consistency, enabling the reliable production of complex oligonucleotides for therapeutic development. Join us to explore how Oligo Factory is advancing the next generation of oligonucleotide-based therapies.
Operational Excellence in Drug Development and Supply Chain Management
- Operational Excellence in Drug Discovery Supply Chain Management" is structured to provide a comprehensive overview of how operational excellence drives efficient, resilient, and high-quality processes across the pharmaceutical value chain—from drug discovery to commercialization. The discussion opens with a focus on Operational Excellence (OpEx) in the context of drug discovery, development, and commercialization, emphasizing its pivotal role in enhancing quality, productivity, and innovation throughout the product lifecycle.
- Real-world case studies, such as the supply chain maps for Fasenra and Imfinzi, will illustrate the practical application of OpEx principles in managing the complex logistics and regulatory requirements of life sciences products. The summary then explores the core principles underpinning operational excellence, including continuous improvement, process standardization, and value creation, as well as the importance of robust business process management.
- A detailed review of the tools and techniques used to achieve operational excellence will be provided, encompassing methodologies such as Lean, Six Sigma, and digital enablement. This will be supported by further examples highlighting successful operations and supply chain initiatives, demonstrating how OpEx concepts translate into measurable performance improvements. The agenda also addresses how to navigate volatile, uncertain, complex, and ambiguous (VUCA) environments, reflecting on the need for agility and adaptability in current global supply chains. Finally, the role of people and culture in underpinning operational excellence will be considered, highlighting the importance of leadership, cross-functional collaboration, and a continuous improvement mindset.
Roundtables
AAV as a Vector for Gene Therapy Delivery
Analytical and structural characterization of mAbs, biosimilars, ADCs, BsAbs, and Fc fusion proteins
Automation and AI in Mass Spectrometry Workflows: Hype or Hope?
Dry State, High Stakes: Formulating the Future of Biologics
Generative AI for Protein Design General Inception - A venture capital firm that partners with innovators to nurture groundbreaking ideas across the biotechnology sector
Identifying and resolving pain points in biomanufacturing
ML for engineering multi-specific antibodies
Recent Trends for Immune-Cell Engagers: TCR-mimic antibodies.
Targeting the CNS
Advancing Peptide Therapeutics: Cell-Based Potency Assays for GLP-1, GLP-2, and GIP Receptor Agonists
Peptide-based drugs represent a cornerstone of modern therapeutics, particularly in the treatment of metabolic disorders. In the evolving landscape of obesity research, GLP-1, GLP-2, and GIP receptors have emerged as key targets for next-generation therapies. Reaction Biology supports this innovation by offering custom research-grade peptide synthesis and robust cell-based potency assays tailored to these receptor systems.
Our assay platform utilizes an indirect cAMP readout to quantify receptor activation, enabling precise IC₅₀ determination for each receptor independently. This approach supports both early-stage drug development and batch release testing. We demonstrate the platform’s capabilities through in-house synthesis of Semaglutide, development of a GLP-1 assay using Saxenda as a model agonist, and comparative analysis of marketed reference compounds including Liraglutide, Tirzepatide, and Teduglutide.
By enabling receptor-specific potency profiling and supporting single- or dual-receptor targeting strategies, our assay system provides a powerful tool for advancing peptide drug discovery. Importantly, these assays can also be performed under GMP conditions for batch release testing.
Biosimilars in Denmark: Easy market access, high uptake, increased patient care and sustainable health care budgets.
Building trust through Pharmacovigilance, Compliance, and Quality
Enhancing Antitumor Responses through Combined Checkpoint Inhibition
- Review of key checkpoint inhibitors and their individual mechanisms of action
- Preclinical and clinical evidence supporting the synergistic effects of combination strategies
- Perspectives on future directions, safety considerations, and patient selection for combination therapy
Expanding the use of monoclonals antibodies into cellular immunotherapy
Gene Therapies: What the future holds
Generative AI for Protein Design
Insights into the future of Gene Therapy
Multifunctional Antibodies for Oncology & other diseases (Preclinical & clinical examples of different formats from Oncology & further indications)
Multifunctional Antibodies for Oncology & other Diseases (Preclinical & clinical examples of different formats from Oncology & further indications)
Predicting Intestinal Therapeutic Protein-Target Engagement in Inflammatory Bowel Disease with a Minimal Physiologically-based Pharmacokinetic (PBPK) Model
Prediction of antibody developability properties at scale
- We developed machine learning models to efficiently predict key antibody developability properties.
- Predictions can be scaled up to process large numbers of antibodies.
- Our models can be used in a multi-objective optimisation setting.
Selective Human Receptor Modulating Peptides for GPCR agonism and antagonism
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What makes your antibodies happy if not (anti-)genius purification
Advances in Structure-Based Computational Modeling and Collaborative Enterprise Informatics for Biologics
Optimizing biologic drug candidates to enhance favorable traits or minimize liabilities often demands significant experimental effort. This presentation will showcase recent progress in our physics-based, structure-guided computational methods that help accelerate the optimization process. It will cover key challenges in antibody engineering—including predicting antibody-antigen binding affinity, improving structural stability, and addressing developability concerns. The talk will also illustrate how these approaches can be integrated within a collaborative informatics platform for biologics discovery, which can merge machine learning (ML) results, experimental data and advanced modeling, execution, and analysis tools to streamline decision-making and centralize essential project information.
Cutting Through the Hype: Real-World Applications of AI in Antibody Discovery and Engineering
Senior Representative, Ailux
Expediting Online Liquid Chromatography for Real-Time Monitoring in Downstream Processing of Biopharmaceuticals
The application of Process Analytical Technology (PAT) principles for manufacturing of biotherapeutics proffers the prospect of ensuring consistent product quality along with increased productivity as well as substantial cost and time savings. Although this paradigm shift from a traditional, rather rigid manufacturing model to a more scientific, risk-based approach has been advocated by health authorities for almost two decades, the practical implementation of PAT in the biopharmaceutical industry is still limited by the lack of fit-for-purpose analytical methods. In this regard, most of the proposed spectroscopic techniques are sufficiently fast but exhibit deficiencies in terms of selectivity and sensitivity, while well-established offline methods, such as (ultra-)high-performance liquid chromatography, are generally considered as too slow for this task. To address these reservations, we introduce here a novel online Liquid Chromatography (LC) setup that was specifically designed to enable real-time monitoring of critical product quality attributes during time-sensitive purification operations in downstream processing. Furthermore, we will highlight the expansive opportunities of online LC based applications to serve as a PAT tool for biopharmaceutical manufacturing.
Improved Antibody Discovery using High-Density Antigen Display with Engineered Virus-Like Particles
Senior Representative, Icosagen
Myeloid checkpoint blockade in combination with IgA antibodies
- IgA antibodies improve myeloid effector cell recruitment
- myeloid checkpoint blockade to enhance antibody efficacy
- novel approaches to interfere with sialic acid/Siglec interactions
Panel Discussion: Finance & Investment for Start Ups
Promises and Challenges of CAR - T therapies
Revisiting Biomarkers in Lupus Nephritis
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Affinity by Design – Building Scientific Software Inspired by Natural Antibody Evolution
Anti-tau immunotherapy targeting the core demonstrates potential best-in-class potency for indication of Alzheimer’s disease and other tauopathies.
Artificial intelligence methods to detect dengue-specific antibody repertoire and sequence patterns
Challenges of Viral Clearance in a Downstream AAV Process and future directions
Ensuring Fast & Reliable Antibody Drug Development for Autoimmune Diseases
Autoimmune disease is a collection of multiple severe clinical conditions that affect 3-5% of the total population worldwide, involving disrupted immune cell activation and escalated inflammation in the patients. Amongst other biologics, therapeutic antibodies are a leading and increasingly widely applied approach. With the rapid exploration of new targets and signaling pathways, numerous targets remain to be discovered and optimized. In this talk, we present various case studies, technologies, and analytical methods designed to ensure a ‘native’ protein that is structurally and conformationally accurate, maximizing bioactivity and assisting in the discovery of new targets for autoimmune diseases.
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Unlocking Precision: The Versatility of Athebody Platform for targeted Therapeutics
CUE-401: A Novel IL-2/TGF-beta Fusion Protein for the Induction & Expansion of FOXP3+ Regulatory T Cells
In Silico Immunogenicity Risk Assessments: AI- Enhanced Prediction of Clinical Immunogenicity Outcomes with EpiVax’s ISPRI Toolkit
The development of biologic therapeutics necessitates comprehensive strategies to assess immunogenicity, a key factor influencing drug efficacy and safety. This presentation will focus on the innovative use of in silico immunogenicity risk assessment tools, particularly the AI-enhanced ISPRI (Interactive Screening and Protein Reengineering Interface) toolkit from EpiVax. ISPRI’s computational methods identify effector and regulatory T cell epitopes and predict anti-drug antibody (ADA) responses, offering insights into minimizing risks during the drug development process.
As biologic formats increase in complexity, assessing the immunogenic potential of various constructs becomes critical. The adaptation of established immunogenicity analysis approaches to evaluate CD4+ T cell epitope content in multifaceted biologic formats, including non-antibody scaffolds and bispecific antibodies, will be discussed. This adaptation offers valuable insights into the distinct characteristics of individual components that may influence immunogenic responses. In a retrospective analysis of monoclonal and bispecific antibodies, ISPRI predictions provided consistent results in a fraction of the time and cost compared to published immunogenicity risk assessments made by combining observations from three in vitro assays and public in silico tools. In addition, nearly all (92%) promiscuous T cell epitopes predicted by ISPRI aligned with peptides identified in MHC-Associated Peptide Proteomics (MAPPS) assays, considerably outperforming traditional public T cell epitope prediction tools.
AI and machine learning (ML) have recently been integrated into ISPRI, significantly enhancing its predictive accuracy by a six-fold increase in the correlation between predicted and observed ADA rates, as well as an 85% reduction in false negatives. The integration of AI into in silico immunogenicity assessments represents a significant leap forward in the biopharmaceutical development landscape. By enhancing the predictive capabilities of existing tools like ISPRI, researchers can make informed decisions early in drug development, ultimately leading to safer and more effective therapeutic options.
IOMX-0675 - A Differentiated and Highly Potent LILRB1 and LILRB2 Targeting Antibody
- LILRB1 and LILRB2 play an important role in modulating the immunosuppressive tumor microenvironment in solid tumors while LILRA1 and LILRA3 are closely related immune-activating family members
- We applied our proprietary phage display library to select IOMX-0675, a fully human antibody, clearly differentiating between LILRB1/2 and LILRA1/3
- The unique binding profile translates into high efficacy positioning IOMX-0675 as a dual-targeting checkpoint inhibitor with best-in-class potential.
- Recent CTA approval enables preparing for a FIH study
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Senior Representative, Kactus
Unlocking Europe’s Biotherapeutic Potential: Biosimilar Policy That Works for Patients and Industry
- The Biotech Act & Competitiveness Compass: Reframing Biosimilar medicines as Strategic Assets
- CompetitionBeyond Price: A New Access Paradigm in Pharma Legislation Reform
- Closing the Biosimilar Void: Converting Potential into Uptake and Access
A Brief History of Biosimilars Development,...an Unfinished Symphony
A machine learning-driven approach for the multi-parametric optimisation of T-cell engagers
T-cell engagers (TCEs) promise breakthroughs in the treatment of solid tumors, but their progression in the clinic is limited by on-target, off-tumor toxicity. In this talk, I describe how our platform integrates active learning, automation, and high-throughput functional assays to efficiently identify highly selective and potent TCEs. I highlight our utilization of the design-build-test-learn ecosystem to generate high-quality data that powers our machine learning models and therapeutic assets.
Clinical Trial Design and Regulatory Considerations for Hematological Gene Therapies
Computational Protein Stabilisation: What Works, What Doesn’t, and Why
- I present a structured overview of computational methods currently available for protein stabilization.
- Drawing on both published literature and our internal efforts, I evaluate the relative effectiveness of these tools.
- I propose potential factors underlying the different success rates of these methods in stabilizing proteins.
Engineered IL-2/antibody fusion proteins confer autoimmune disease protection through selective expansion of specific immune cell populations
- Progress in cytokine engineering is driving therapeutic translation by overcoming the limitations of these proteins as drugs
- We designed intramolecularly assembled single-agent fusion proteins (immunocytokines, ICs) which comprise of IL-2 linked to various biasing anti–IL-2 antibody that direct the cytokine towards regulatory immune cells, leading to superior autoimmune disease protection
- F5111 IC, which potently and selectively activates and expands regulatory T cells, conferring disease protection in mouse
- models of ulcerative colitis and immune checkpoint inhibitor-induced diabetes mellitus
Light On – Tumor Off: How Quencher - Fluorophore Technologies Improve ADC Designs
- Mechanism of Action: Understanding how ADCs deliver cytotoxic drugs directly to cancer cells.
- TORCH Technology: A groundbreaking tool for tracking internalization and release kinetics.
- Insightson target receptor expressions and ADC potencies.
New opportunities to overcome the efficacy and toxicity problems of immunotherapies with affinity-switchable antibodies
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Accelerating Breakthrough Innovations in Healthcare
- The Johnson & Johnson external innovation team is interested in collaborating with entrepreneurs at startup companies, universities and institutes who are developing early-stage innovations that are pre-proof of concept in humans across the Innovative Medicine and MedTech business segments
- Our JLABS incubators offer the largest global network of open innovation ecosystems that enables and empowers emerging companies with knowledge, experience, partnerships, and venture connections across a broad healthcare spectrum
- JJDC is Johnson & Johnson's corporate venture capital (CVC) organization. With more than 50 years of experience, we are the longest-running healthcare CVC in the world. We invest in medtech and biotech innovation across all stages of translation
Clinical and Molecular Characterisation of Primary Refractoriness to Atezolizumab plus Bevacizumab in Patients with Unresectable Hepatocellular Carcinoma
- Primary refractoriness to atezolizumab plus bevacizumab in hepatocellular carcinoma, as defined by SITC criteria, is associated with poor clinical outcomes.
- Tumour microenvironment profiling reveals an immunosuppressive phenotype characterized by high myeloid infiltration, reduced interferon-γ signalling, and T-cell depletion.
- The combination of systemic inflammation and low IFN-γ signature expression strongly predicts primary refractoriness and may inform therapeutic decision-making.
Engineering a multimodal protease inhibitor for respiratory indications
Formulation development for biologics
Generative AI for Inverse Problems in Biomedical Computational Microscopy
Advanced microscopy techniques, including three-dimensional, super-resolution and quantitative phase microscopy, remain at the forefront of biomedical discovery. These methods enable researchers to visualise complex molecular processes and interactions at the level of single molecules or molecular complexes, capturing yet unseen information and pushing the boundaries of our understanding of health and disease. These innovations have been made possible, among others, through rapid progress in biophotonics, as well as computational processing and analysis of image-based data. However, advanced biophotonics comes at the cost of complex equipment, as well as difficult and lengthy data acquisition and necessitates highly-trained personnel. We demonstrate in several works that this hurdle can be addressed using generative and discriminative AI algorithms by formulating the conversion from conventional microscopy modalities like widefield, to advanced like super-resolution, as a set of inverse problems. We show that incorporating nuance of the data domain into the algorithm design, as well as leveraging synthetic data pre-training, leads to better performance in these algorithms. Among other examples, we demonstrate how Generative AI algorithms can be utilised for Virtual Staining of virus infection in cultured cells, allowing for quasi-label-free detection of infected cells.
ISB 2001, a First-in-Class Trispecific BCMA and CD38 T Cell Engager Designed to Overcome Mechanisms of Escape from Multiple Myeloma Treatments
Optimization of a Next Generation FcRn Inhibitor Fused to an Albumin-Binder for Improved IgG Clearance
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Advances in pHLA directed T cell engager discovery and design
Insights into Successful Industrial Clinical Collaborations
Panel Discussion: Finance & Investment for Start Ups
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Senior Representative, Lonza
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Attenuated cytokine antibody fusions for enhanced anti-tumor activity
Designing Potent TCR-based T Cell Engagers for Cancer Immunotherapy with Generative AI
Etcembly is the first company to leverage generative AI to discover and engineer a T cell receptor (TCR) to picomolar affinity. We formatted our lead PRAME targeting molecule, ETC-101, into a trispecific T cell engager and demonstrated that ETC-101 specifically redirected T cell killing of PRAME-positive cancer cells only, while demonstrating a promising safety profile with no detectable off-target effects. Our data highlights the efficacy of ETC-101 as a novel drug candidate for the treatment of a wide range of PRAME-positive malignancies.
Drug Discovery from Bench to Bedside: The Story of Anti-Factor XI Antibody Abelacimab (MAA868)
- Abelacimab (MAA868) is a monoclonal antibody targeting Factor XI, which promises a paradigm shift towards safe, long-acting thrombosis prevention, without the bleeding risk inherent to current anticoagulant drugs
- The presentation traces the discovery journey of abelacimab - from the initial target hypothesis through the identification of its unique mechanism of action, pivotal preclinical findings, and first-in-human clinical proof-of-mechanism.
- Abelacimab is currently undergoing active clinical evaluation in Phase 3 trials.
Engineering bispecific sdAb-based antibodies
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Biosimilar Market Sustainability Panel
Biosimilar Sustainability Panel
First-in-class anti-TRPV6 antibody as a new therapeutic agent in oncology
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Unlocking the Clinical Potential of Immunoglobulin G Glycosylation through Integration of Large-Scale Population Data and Mechanistic Insights
- Changes of IgG glycosylation in aging and disease (IgG glycans as biomarkers)
- Functional role of IgG glycosylation in the immune system (IgG glycans as functional effectors of inflammation)
- Targeting IgG glycosylation
- In vitroto fine-tune therapeutic IgG glycosylation
- In vivoto fine-tune serum IgG glycosylation by lifestyle and medical interventions
Antibody Secreting Cells Repertoire for Drug Discovery, Potential & Reality
Drug therapies based on Monoclonal Antibodies are an incontestable success for patients, but the rapid generation of potent antibodies remains a challenge. Secreted antibodies from ASC appear to be promising but require new technologies to be addressed and have yet to demonstrate a clear advantage over traditional display antibodies. To interrogate the antibody secreting cells (ASC) repertoire we optimized a single cell droplet microfluidic pipeline to increase the robustness. For the display antibody repertoire, we used the traditional pipeline based on single B cell (sBC) technology that combines the use of a FACS (Fluorescent Active Cell Sorting) and scRT-PCR (single cell Reverse Transcriptase PCR). We also evaluated an optimization of this sBC pipeline by replacing the scRT-PCR by a scRNA-Seq based on a 10x Genomics. Based on these two pipelines, we elaborated a head-to-head comparison of the antigen affinity of their respective antibodies.
Conquering The Last Frontier: Developing Ion Channel Modulating Antibodies
Ion channels are an important target class implicated in several untreated or poorly treated diseases. Despite the unmet need and the potential of monoclonal antibodies (mAbs) in this domain, no mAbs targeting ion channels have achieved clinical approval or are in clinical development. Maxion has shown that small cysteine-rich miniproteins (knottins) with ion-channel modulating activity can be inserted into antibody CDRs to create a novel mAb format called KnotBodies. KnotBodies maintain the ion channel activity of knottins while benefitting from the optimal drug-like properties of antibodies. This presentation will illustrate the discovery and optimisation of KnotBody inhibitors to therapeutically relevant ion channel targets.
Engineering a linker-less ADC
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Keynote Panel Discussion: Next Generation Antibody Formats
· Exploring the current state of antibody modalities and emerging therapeutics
· Advances in established formats: next generation bispecifics and ADCs
· The potential of AI in antibody engineering – what place does this technology hold in antibody development?
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Clinical mass spectrometry
Developability assessment of antibody modalities with complex antigen-binding regions
How to prevent protein aggregation through stabilizers and surfactants
Insulin Neoepitopes as Biomarkers and Potential Therapeutic Targets in Type 1 Diabetes
Synthetic Genetic Systems for Improving Protein Expression
The Localization of T-cell epitopes in biopharmaceuticals: from peptides to gene therapy vectors
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Turning enzymes into effective enzybiotics
This presentation explores the innovative approach of engineering enzymes to develop enzybiotics—enzyme-based antibacterial agents—as a promising alternative to traditional antibiotics. It highlights how specific modifications, such as domain swapping, mutagenesis, and fusion with targeting peptides, can enhance enzyme stability, specificity, and bactericidal efficiency. The talk also covers recent successes in combating multidrug-resistant pathogens and discusses future directions for optimizing delivery, broadening the antibacterial spectrum, and overcoming resistance mechanisms.
Unlocking New Target Opportunities In Oncology
A Single Punch to Rewire Immunity: Reprogramming the Tumor Microenvironment via Metabolic Intervention
- PLT012, a monoclonal antibody blocking CD36-mediated lipid uptake,demonstrated strong anti-tumor activity in liver malignancies with durable protection.
- PLT012 remodelsthe tumor microenvironment through reduction of immunosuppressive cell populations and simultaneously boost effector cell populations with remarkable safety profile.
- Pilatus has established a robust translational framework—including ex vivo patient-derived tumor fragment testing, in silico analysis, and multiplex staining—to explore predictive biomarkers. This strategy supports rational patient stratification and increases the likelihood of clinical trial success before entering FIH.
Next-generation TCR-like antibodies with improved specificity profiles
In this talk, we introduce YUMAB’s advanced TCR-mimic discovery platform addressing the off-target-pHLA binding challenge. Employing our technology, we discovered highly specific, human antibodies against the cancer antigen WT1. Our antibodies outperform established references (e.g., 11D06, ESK1) in affinity and specificity without additional engineering. As a next step, we integrate these TCR-like antibodies with proprietary anti-CD3 antibodies to develop bispecific T cell engagers (“safeTY-engagers”). This innovative approach, funded by the BMBF (safeTY-engager, ID: 16LW0341), aims to enhance precision and safety in cancer immunotherapy.
Role of automation in Protein mass spectrometry: from lead discovery to bioprocess modeling
Modern biopharmaceuticals, a substantial part of Roche's Large Molecule Research (LMR) project portfolio, are highly engineered, often bispecific proteins that address complex modes of action for disease treatment. Mass spectrometry (MS) is a well-established technology, easily capable of identifying proteins and their potential side products. Automation of protein MS analysis has already been successful in applications that require repeated analysis of samples from one well-characterized protein, e.g., throughout process development of biotherapeutics in clinical development.
This talk will showcase the approach taken by Roche's LMR MS unit to enable high-throughput MS analysis for protein screening or process modeling applications that were previously too demanding due to sample diversity and sample numbers.
Fc-enhanced monoclonal antibody therapeutics to activate the tumour microenvironment
Antibody design to fine tune effector functions harbours potential to improve therapeutic effects. This talk will focus on two antibody Fc modification approaches that consider the immune composition of the tumour microenvironment: IgG Fc-engineering and generation of antibodies with IgE class Fc regions. Cancer biology and immunology guided antibody design can harness immune effector mechanisms and may hold promise for precision medicine, especially for patients with aggressive and treatment-resistant cancers.
In silico Immunogenicity profiling
In vivo models to predict clinical outcome of multispecific cancer therapeutics
Profiling and characterizing O-glycosylation in the hinge region of immunoglobulin A by bottom-up mass spectrometry.
IgA Nephropathy is an autoimmune disease which has been recognized as an important cause of chronic kidney disease and end stage kidney failure. This condition is marked by the production of aberrantly glycosylated IgA1 by memory B and plasma cells. Therefore, characterizing the glycosylation pattern of IgA1 is crucial.
IgA1 undergoes post-translational modification through O-glycosylation at six serine and threonine residues in the hinge region. This results in a wide heterogeneity of O-glycoforms, which can be categorized into two groups: galactose-deficient (where at least one GalNAc residue is not linked to a Galactose residue) and non-galactose-deficient.
An automated profiling workflow is employed to classify the O-glycosylation pattern of IgA1 using LC-MS after tryptic digestion. Additionally, an in-depth characterization method has been developed to pinpoint the galactose-deficient sites. This method combines specific enzymes, IgASAP™ Sub1+2 (Genovis), and O-glycosidases, along with EAD fragmentation, a feature of the ZenoTOF 7600 mass spectrometer from Sciex.
Streamlining Biosimilar Development
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Utilising protein engineering and chemistry to functionalise antibodies
Reserved for AstraZeneca
VHP Ingress unveiled: Protecting Quality in Closed System for ATMP Manufacturing
ATMPs are very promising therapies for many diseases, from several cancer types to rare genetic disorders. Their type, nature and manufacturing processes are quite different, as well as the doses and way of administration. Due to this wide variety, the Bill of Material for manufacturing processes can be quite big and heterogeneous, from patient’s cells to sensitive materials such as media or specific reagents.
Isolators are a safe and compliant platform for ATMP manufacturing, being a closed system with a sound decontamination control of chambers and materials by H2O2 (VHP, Vapour Hydrogen Peroxide).
Material decontamination by H2O2 can be challenging when materials such as the above must be transferred into the A zone. How to overcome those challenges and how to ensure a safe and compliant material transfer to the isolator chamber? SKAN will show VHP ingress studies on typical raw materials for ATMP as well as current ways of fast and safe material transfer
Bioanalytical studies of oligo based therapies
CMOs as Strategic Partners: The Evolving Landscape of Fill-Finish in Commercial Biologics
As the commercial biologics landscape grows increasingly complex, fill-finish Contract Manufacturing Organizations (CMOs) have become critical strategic partners in ensuring product quality, supply continuity, and speed to market. This presentation will explore the evolving role of CMOs in commercial biologics manufacturing, highlighting key trends, emerging technologies, and operational challenges. Drawing from real-world experience, the talk will examine best practices for building resilient, collaborative partnerships with CMOs and provide strategic guidance on navigating capacity constraints, regulatory expectations, and global supply chain risks. Attendees will gain practical insights into how to future-proof their fill-finish strategies in an ever-changing environment.
Generation of antibodies for HCP monitoring
Mass spectrometry-based biodistribution of biotherapeutics: an alternative to radio-biodistribution
Merus Class of Bispecific ADC (ADClonics) to Achieve Improved Binding Selectivity, Internalization, and Tumor-Cell Killing
Translating Bispecific Costimulatory Antibodies into First-in-Human Trials: Bridging Preclinical Development to Clinical Application
Immunogenicity potential assessment at Novartis
Evaluating the immunogenicity potential of biotherapeutics is becoming increasingly important and challenging at the same time. The presentation will provide an overview over how Novartis is conducting immunogenicity potential assessment from the design space to the clinics. Categories and elements of this assessment will be presented, for example the mode of action of the drug, similarity to endogenous proteins, critical quality attributes or the immune status of the patient. The presentation will cover the immunogenicity risk assessment questionnaire as well as different types of assays which can be applied to support the selection of biotherapeutic candidates and to understand mechanistic root causes of immunogenicity.
Moving away from Acetonitrile and TFA to greener eluents in Biopharma LC-MS
With growing awareness of the environmental impact of laboratory operations, the principles of green chemistry are gaining momentum within the analytical community. Although not typically viewed as major sources of greenhouse gas emissions, reversed-phase liquid chromatography (RP-LC) reliant analytical labs consume large volumes of environmentally hazardous solvents such as acetonitrile (ACN) and halogenated additives. In this study, we present a biodegradable, less toxic solvent system for RP-LC-MS that replaces the conventional solvent mixtures, by combining an uncommon but highly effective solvent for RP and an exceptionally strong non-PFAS ion pairing agent. The resulting system demonstrated superior chromatographic resolution and mass spectrometric sensitivity compared to the ACN standard, while significantly reducing organic solvent usage and CO₂ emissions. This approach supports a broad range of biopharmaceutical applications, including intact, subunit, and reduced antibody analyses. The method offers a practical and scalable path toward greener LC-MS workflows in therapeutic protein analysis.
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Inducing antigen-specific immune tolerance with chimeric non-classical HLA molecules inspired by pregnancy
Panel Discussion: 2025 In Review and Trends into 2026
· Reviewing key advances in recent trends for antibodies and immunotherapies
· Current status of projects outside of oncology: advances in autoimmune conditions, treating inflammation and infectious diseases
· AI and it’s impact on the industry – have we arrived at a tipping point?
· The drive for accessibility and patient centric care
· Europe’s place in the global market: Europe’s pricing and regulatory framework, and changes in the US research landscape
Targeting TNFR2 for Therapeutic Purposes
Powder Power: Transforming Biologic Modalities with Dry Formulations
- Biologic therapies are transforming medicine, but their full potential is often limited by challenges in stability, storage, and delivery (especially for complex modalities like cell and gene therapies).
- Dry powder formulations offer a promising solution, enabling enhanced stability, simplified logistics, and new routes of administration, including needle-free options like nasal delivery, that can improve patient access and compliance.
- By rethinking formulation from the ground up, we can unlock new possibilities for advanced therapies, accelerating innovation and expanding the reach of life-changing treatments.
Minimizing Polysorbate Degradation with Pfanstiehl’s Histidine - Case Study Presentation & Challenges of Formulating Complex Biologics
Polysorbate degradation is a persistent challenge in biologics formulations, often driven by trace metals contamination such as iron (Fe) and copper (Cu) often found in excipients. Pfanstiehl's highly processed & purified excipient grade amino acids , refined to remove trace metals to single-digit parts per billion, offer a solution. In a customer-developed case study, the use of Pfanstiehl's High Purity Low Endotoxin Low Metals L-Histidine successfully prevented polysorbate degradation under high-temperature accelerated stability conditions, demonstrating its effectiveness in preserving surfactant integrity. The presentation will also cover some aspects of challenges of formulating complex Biologics.
Unlocking the Clinical Potential of Immunoglobulin G Glycosylation through Integration of Large-Scale Population Data and Mechanistic Insights
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