Messe Basel, 13 - 15 October 2026
Schedule
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Chair's Opening Remarks
Biotechnology, the Renaissance
- Evolution of biotechnology
- Opportunities as complex biological molecules emerge
- Convergence of technologies
Microbial Platform Reimagined in the Era of Innovative Modalities – Enabling Lower COGs, Faster Development, and Scalable Manufacturing
Senior Representative, WuXi Biologics
From policy to patients: The landscape reshaping global biosimilar access
Sandoz Global Head of Biosimilars, Isabell Remus, will explore the recent developments creating unprecedented opportunities to drive biosimilar development and uptake. From thelatest regulatory shifts towards streamlining biosimilar developmentto theEU’s Critical Medicines Act, Isabell will explore what these movements mean for the biosimilar industry and patient access. She will discuss key opportunities to overcome barriers to access and how to build on current momentum as the global demand for affordable medicines continues to rise, delivering a definitive win for patients and the sustainability of healthcare systems worldwide
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Senior Representative, Danaher
Advances in Cell Line Development at Novartis
Antibody-Based Products: Successes & Progresses in 2026
Binding proteins from knowing just the target sequence
Bringing medicine development to patients, The why and the how
From reflection to implementation: streamlined development of biosimilars with pembrolizumab as case study
Biosimilars development: the next chapter and the impact of waiving phase III studies on biosimilars landscape
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Senior Representative, WuXi XDC
PANEL DISCUSSION: The Final Frontier: Microgravity and Low Earth Orbit as the Manufacturing Environment of the Future, sponsored by BioOrbit
Panel Discussion: The Next Frontier: Integrating Next-Gen Science with Sustainable Commercial Models in Cell Therapy
PB-223, A Novel Antibody Drug Conjugate Targeting Truncated Core-2 Glycans in Solid Tumors
Protecting healthy volunteers in clinical trial - The VolREthics initiative
Ensuring regulatory compliance in clinical trials
Patient-First Manufacturing: Closing the Mid-Scale Biologics Gap
Accelerating multispecific antibody discovery & development with the B-Body platform
Discover the B-Body® platform, thehigh-performancesolution for accelerating multispecific antibody development. Achieve CMC-ready bispecifics in just four weeks with B-Body Express™ platform. Our proprietary design eliminates light chain mispairing, delivers exceptional yields up to 11 g/L,and ensures low manufacturing risk using standard mAb purification. Screen in the final therapeutic format, including Fc mutations and ADC compatibility, and mitigate risk across all development stages.
Manufacturing & Industry Strategy Roundtables
From Components to Complete Solutions: Redefining Single-Use Supply in Bioprocessing
Scaling Up: Addressing Manufacturing Bottlenecks in Autologous Cell Therapies
First in Human Dose Selection for ADCs and TCEs Using PK/PD and QSP
First-in-human dose selection remains one of the highest-stakes decisions in oncology drug development—particularly for complex modalities such as Antibody-Drug Conjugates (ADCs) and T-cell Engagers (TCEs). Misjudging this step can lead to delayed development, unnecessary patient risk, and significant value loss.
In this workshop, LYO-X presents an integrated, model-informed strategy to de-risk and accelerate FIH dose prediction. For ADCs, the focus is on translating preclinical data into a robust understanding of therapeutic dose and window. For TCEs, the challenge lies in identifying a starting dose that is both safe and sufficiently close to pharmacological activity, minimizing dose-escalation steps and avoiding subtherapeutic exposure.
By combining in vitro and in vivo preclinical data with advanced PK/PD and quantitative systems pharmacology (QSP) modelling, LYO-X demonstrates how to generate data-driven, decision-ready dose recommendations. The session will highlight how this approach enables more confident clinical entry, optimizes trial design, and ultimately accelerates time to proof-of-concept.
An AI driven, cell-free vaccine platform
Digital and AI transformation strategies
Drug product development for biologics
Engineering Human Cell Surface Receptors for Epitope Editing and Selective Targeting
High-Affinity CXCR4 Antibodies enabled by Salipro Nanoparticles and Phage Display
Insights into successful clinical collaborations
Insights into the history and rationale of biological standardization
Switchable antibody technology
Systems biology approaches in improving quality and titer of biologics
Targeting T Cell Activation with JJP1008: A Novel Agonistic mAb in Preclinical Melanoma Cancer Models
Development of next-generation T cell engineering strategies targeting solid tumors
Driving Biologics Innovation: A New Innovation Ecosystem for High-Impact Discovery at Roche pRED
ISB 2001, a First-in-Class Trispecific BCMA and CD38 T Cell Engager Designed to Overcome Mechanisms of Escape from Multiple Myeloma Treatments
Navigating Speed, Complexity, and Scalability in Biomanufacturing Selecting Phase-Appropriate Upstream Strategies from Rapid Platform to Intensified Processes
The pressure to accelerate biologics to the clinic while accommodating an increasingly diverse range of molecule formats is reshaping biomanufacturing strategies. Using ProBioGen's CMC Navigator™ as an example of a structured manufacturing roadmap, this presentation explores how phase-appropriate CMC strategies and a fit-for-purpose manufacturing toolbox support informed manufacturing decisions aligned with evolving program priorities.
While platform fed-batch remains the preferred strategy for rapid clinical development, intensified fed-batch and perfusion offer opportunities to improve manufacturing efficiency where appropriate. Selecting the optimal strategy requires balancing development timelines, process complexity, scalability, and molecule-specific requirements rather than adopting a one-size-fits-all approach.
Drawing on a CDMO perspective, the presentation will feature case studies illustrating how different program priorities translate into different upstream process strategies, highlighting the trade-offs associated with scalability, operational complexity, and harvest design. In addition, examples of perfused seed trains and harvest strategies for intensified processes will highlight often-overlooked aspects of upstream process design, demonstrating that critical manufacturing decisions extend from seed train through harvest — not just the production bioreactor.
Pfanstiehl’s Arg.Glu* (Arginine Glutamate) as Ideal Excipient for High Concentration Monoclonal Antibody Formulations
Platform based approaches to collaborative clinical research
Testing Engineered Antibodies at Scale: Cell-Free Screening of AI Designed Panels
Antibody engineering campaigns, whether affinity maturation, humanisation, or computational and de novo design, generate large panels of variant molecules, but only a minority typically bind as intended. Confirming which designs work still depends on mammalian expression, purification and biosensor analysis, a 4–8+ week cycle that spends high-cost biology on variants before their binding is known and slows every design–test iteration.
We present a cell-free protein synthesis (CFPS) workflow that tests engineered antibody panels rapidly, at scale, and low cost. Full-length IgG variants are expressed in a 96-plex format with binary expression/binding classification plus SPR kinetics.
We will showcase two designed AI-generated libraries to illustrate the approach. An anti-PD-1 panel reached 98% expression, identified 66% as non-binders, and achieved 91% concordance with CHO BLI at 3% CV. An anti-IL-6 panel targeting a historically challenging epitope reached 100% expression, identified 83% non-binders, and achieved 94% concordance with CHO SPR.
By resolving which designs express and bind before mammalian scale-up, CFPS lets engineering teams iterate faster and commit resources only to validated molecules — accelerating the design–test cycle at the heart of antibody engineering.
The New Breath: Clinical data from Lunsekimig, a bispecific anti-thymic stromal lymphopoetin (TSLP)/anti-interleukin 13 (IL-13) NANOBODY® molecule in asthma
Think first, worry less, drive compliance: Building a quality culture that anticipates regulatory expectations
A New Paradigm for Biosimilar Development Without the Need for Clinical Efficacy Studies
- Scientific foundation for omitting efficacy studies
- Regulatory evolution and global convergence
- Impact on development efficiency and patient access
Development of novel CAR-NK cell treatments
Host Cell Protein Impurity Control in mAbs: Regulatory Recommendations Updated
Host Cell Proteins (HCPs) threaten the stability, efficacy, and safety of biopharmaceuticals. Regulatory expectations to CMC are rapidly changing to include advanced LC-MS HCP analyses aligned with ICH guidelines and USP chapter <1132.1>. EMA recommends early detection of well-known problematic HCPs in immunotherapies that can guide process optimization for improved HCP clearance, formulation development and risk assessment for patient safely. I will share the latest regulatory recommendations and client cases on regulatory rejections due to insufficient HCP control.
Personalised oral bacteria-based DNA vaccines in early and later-stage cancer patients
- Inducing robust neoantigen-specific immune responses in immunotherapy-treated cancer patients
- Exploring self-adjuvanted personalised cancer vaccines for best patient response
- Monitoring treatment response by ctDNA and other immune biomarkers
Predictive modelling and stability predictions
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Senior Representative, Mosaic Biosciences
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Senior Representation, Kactus Bio
Unlocking Intractable Targets: An In vitro Validated AI Platform for Therapeutic Antibody Design
Unveiling the Chromatic Secrets of a Therapeutic Protein
Antibody Secreting Cells Repertoire For Drug Discovery, Potential & Reality
Drug Product Development for Gene Therapies
How emerging technologies are accelerating next-generation life science innovation.
IgCheck: an LLM-Powered Platform for Early Immunogenicity Risk Assessment in Biotherapeutics
Independent Education about Clinical Development - There is a way!
Navigating the regulatory landscape of cyber and data security
Panel Discussion: From Research to GMP: Making MSC Manufacturing Reproducible at Scale
- Reproducibility as the differentiator:what actually drives batch‑to‑batch consistency in adherent MSC expansion (process + surface + media).
- Scale-up pathways:planar scale-out (stacked/closed configurations) vsmicrocarriers/bioreactors—decision criteria, risks, and “go/no‑go” signals.
- De-risking operations:reducing interventions (e.g., fewer media exchanges) and simplifying workflows without sacrificing phenotype/potency intent.
- Translating to GMP reality:closed/assembled solutions, documentation expectations, and practical lessons learned moving from development to clinical manufacturing.
Targeting Endosomal Escape to Convert Mesenchymal Stromal Cells into Vaccine Vectors
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Developability and manufacturability considerations for next-generation biologics
EMLy: Etcembly's AI platform for faster and smarter drug discovery
Enara’s Dark Antigen Platform for immunotherapies
Examining the effects of counterions on formulation stability, viscosity, and turbidity of mAbs
Exploiting the Molecular Mimicry for Cancer Vaccine Development
From In Vitro Discovery to Modular Protein-Conjugation
Next-generation CHO cell lines for cheaper biosimilar production
Antibody Roundtables
Advancing ADC Development
AI Based Approaches to Antibody Design
Interrogating patient samples, powered by AI
Recent Trends for Immune-Cell Engagers: TCR-mimic antibodies
Adaptive trial designs to expedite clinical development
- Design options to expedite development
- Regulatory hurdles and learnings
- Real life example of Memo Therapeutics and others
Advances in Lynch Syndrome cancer vaccine
Approaches to excipients and polysorbates for antibody modality formulation
Beyond Conventional T Cells: Exploiting iNKT Cell Biology for Cancer Therapy
· Overview of unconventional T cell biology and why iNKT cells are attractive therapeutic candidates
· How functional and metabolic diversity influences anti-tumour activity
· Translating these insights into next-generation, off-the-shelf cancer immunotherapies
Building cross-border AI-ready data infrastructure and next-generation clinical trials
Design of novel antibody therapies for solid tumours: Insights from studying the patient immune response and tumour vulnerabilities
Enhancement of Solubility of Inclusion Bodies of Recombinant Peptide Using AI
From Biogeneric to Biosimilar to Biogenetic: Finally, the FDA Removes Clinical Efficacy Studies for Monoclonal Antibodies
Optimizing recombinant protein expression workflows by leveraging automation and predictive models
-In silico and wet lab automated workflows for recombinant protein expression
-Developing the next generation predictive model for optimal codon usage at the translation initiation region
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BiXAb MAIT engagers: redirecting an abundant cytotoxic T-cell subset to control solid tumors.
Cultivating innovation: Evolving Cell Line Development for next-generation biotherapeutics
Advanced cell line development is critical to the success of biotherapeutic development, requiring high productivity, stability, and consistent performance from early stages through commercial manufacturing. Building on the Selexis® SUREtechnology™ foundation and CHO-M™ cell line, we have evolved our TranspoEase™ platform to enhance efficiency and flexibility. Our in-house engineered transposase drives improved integration and higher titers, while our novel Biselect multi-selection strategy ensures optimal chain pairing and strong expression of complex, multi-chain molecules without added vector design complexity. We also integrate developability assessment early in the workflow to support smarter candidate selection and reduce downstream risk. Looking ahead, we are redefining safety standards with the development of the first RVLP-low host cell line on the market—setting a new benchmark for next-generation biomanufacturing.
De novo and data-driven nanobody design with machine learning
From Bench to Bedside: The Role of Routine Immunology in Patient Management
From Rational CAR Design to First-in-Human Translation: Expanding CAR-T to T-ALL and Beyond
In vivo modulation of IgG glycosylation via endothelial FcRn
Misaligned Decisions in Vaccine Regulation: A Hidden Driver of Delay and What Sponsors Can Do About It
- Regulatory decisions follow a structured logic - but this logic is often implicit and not clearly articulated.
- Through case studies, this talk illustrates how this "hidden gap" in understanding by sponsors can lead to misalignment, rework and delay - slowing vaccine development.
- Practical strategies are derived to help sponsors navigate regulatory interactions more effectively. By clarifying regulatory assumptions, constraints and framing risk effectively, sponsors can navigate regulatory uncertainty more effectively and reduce risk to vaccine development program
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Senior Representative, Lonza
Towards a polysaccharide-based Group B Streptococcus vaccine for Global Health
VHH Antibody Discovery Pipeline Combining Cell-Free Expression in Picoliter Droplets and Bead-Based Digital Droplet PC
APC-targeted immune-priming technology using sdAb for cancer therapy
Despite the breakthrough of immune checkpoint blockade, the majority of cancer patients still fail to benefit due to a lack of cancer-specific T cells. Although various immunization approaches have been explored to increase T cell responses, most rely on non-targeted antigen delivery systems, leading to limited efficacy. Using our single-domain antibody (sdAb) platform, we selectively deliver cancer antigens directly to antigen-presenting cells (APCs), thereby inducing stronger T cell responses compared with conventional methods. This novel immune-priming technology has the potential to significantly boost anti-tumor T cell responses and promote cancer elimination by harnessing the patient’s own immune system.
Engineering iNKT cell based therapies
From CFD to Digital Twins: Modeling Temperature-Driven Oxygen Transfer in Aerated Bioreactors
From Fermentation to Vaccination: Non-Animal Origin Squalene for High-Risk Application
Involving patients in the Dev lifecycle, rising requirements and impact of engaging
- Involving patients in R&D is no longer a nice to have – expectations of regulators and payors (and patients) are growing
- Input from patients has tangible impact – publications and own examples of impact
- Showcasing a systematic engagement and measurement framework to embed patient involvement in the fabric of R&D
Panel Discussion: Accelerating the Biosimilar Approval Process
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?
The science behind robust cell line development to produce complex biologic therapies
The development of therapeutic biologics is being transformed by advanced technologies with the goal of accelerating timelines while enhancing productivity, quality, and scalability.
This presentation explores how AI/ML-driven analytics, transposase-based gene integration technology, and a proven CHO- K1 cell line platform work together to enable robust cell line development and efficient process optimization.
Attendees will learn how process intensification strategies can drive enhanced cell growth and productivity, achieving titers of up to 11 g/L, while maintaining critical quality attributes.
The session will also highlight how the science behind a robust cell line development platform, combined with advanced analytics and platform expertise, can accelerate the journey from cell line generation to IMPD submission and Phase I clinical trials in as little as nine months,* with the goal of helping biopharmaceutical developers reduce risk and bring innovative therapies to patients faster.
In this session, we’ll discuss:
The role of advanced technologies such as AI/ML, transposase technology, and CHO-K1 cell line in developing a therapeutic biologic
Process intensification strategies to increase growth and titer performance capable of achieving 11 g/L
How the science behind robust cell line development has enabled us to accelerate to IMPD and Phase I clinical trials in as little as 9 months*
*Terms and Conditions: Titer levels provided are estimates based on third party results and may vary depending on molecule type or other factors. Timeline from DNA to drug product and start of clinical trials may vary depending on molecule type or other factors and are estimates to be finalized after third party cell line development dates are available and confirmed. 8-month timeline will incuradditionalrisk and is based on U.S. based sites only. Timeline for clinical trials is dependent on clinical trials being conducted in Australia or New Zealand.
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Senior Representative, Cradle
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Senior Representative, IQVIA, a Specifica Company
Advancing Antibody Discovery Through Integrated single B-Cell Technologies
- Immunisation strategies to maximise immune responses.
- Leveraging single B-cell profiling to identify therapeutic antibody candidates.
- Bridging experimental and computational antibody discovery through integrated wet lab and in silico pipelines.
AI systems for wearable sensors in digital clinical trials
Data privacy and management for trials
Individualized Cancer Vaccines TG4050
PASylation technology – a new dimension in antibody engineering
Rethinking Formulation Development of Biologics
Protein formulation development has traditionally prioritized vial stability, shelf-life, and manufacturability under static conditions — an approach increasingly insufficient for today's high-concentration biologics and subcutaneous delivery formats. This presentation reimagines formulation as a lifecycle discipline that spans from molecule design through to in-vivo performance. High-throughput screening, physiological compatibility testing, and biopharmaceutics-informed strategies can replace narrowly focused stability paradigms. By embedding this integrated mindset early in development, the industry can reduce attrition, lower cost of goods, and improve clinical outcomes.
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The Clinical Landscape: Changes in Clinical Development and Patient Safety
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Senior Representative, Nona Biosciences
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Senior Representative, Lonza
A next generation ADC for Nectin-4 expressing tumors: preclinical characterization of IPH45, a novel and differentiated exatecan-based ADC targeting Nectin-4
Biosimilars in Denmark: Market access. High uptake. Patient care. Sustainable budgets
Characterization and Developability of Next-Generation Biologics: ADCs, CAR T Cells, rAAVs, mRNA and VLPs
CQA of ATMPS: analytical strategies to ensure commercial viability
De Novo Design Via Computational Platforms
Engineering human cytokines for therapy
Regulation of cell therapies and decentralized independent drug development for patients
TCR-Specific Engagers that Selectively Target IL-2 to Tumor-Specific T Cells
Trispecific EGFR x cMET x VEGF Antibody, TAVO412, has Clinical Responses in colorectal, Esophageal and Lung Cancers
What makes your antibodies happy if not (anti-)genius purification
Accelerating Biologics Design with State-of-the-Art In Silico Modeling and Collaborative Enterprise Informatics
Biologics discovery programs face mounting demands to accelerate timelines while navigating increasing molecular complexity, constrained experimental capacity, and data scattered across modeling and experimental systems. Critical decisions — from variant selection to developability risk assessment and structure-guided optimization — are frequently hampered by siloed workfl ows and the challenge of reliably bridging computational predictions with experimental outcomes. In this talk, we will present how physics-based computational modeling (BioLuminate, FEP+) and collaborative enterprise informatics (LiveDesign) can be combined to accelerate modern biologics design. We will walk through an end-to-end workfl ow spanning early structural assessment, liability and developability analysis, and structure-guided engineering powered by advanced free-energy methods. We will also illustrate how in silico predictions can be integrated with experimental data within LiveDesign to drive iterative design cycles, hypothesis generation, and variant prioritization — enabling faster, more confi dent biologics discovery and optimization.
Advances in Ion Exchange and Multimodal Chromatography Resins for Monoclonal Antibody Polishing
The polishing stage of monoclonal antibody (mAb) purification is critical for achieving meeting stringent product quality requirements while maintaining high process yields. Following Protein A capture, residual process- and product-related impurities, including host cell proteins (HCPs), Protein A leachate, aggregates, fragments, nucleic acids, endotoxins, and charge variants, must be efficiently removed to meet regulatory expectations. Ion exchange (IEX) and multimodal chromatography resins have become essential tools for addressing these purification challenges.
Recent advances in resin design have expanded the capabilities of both traditional ion exchange and multimodal chromatography platforms. Anion exchange (AEX) and cation exchange (CEX) resins provide selective impurity removal through electrostatic interactions, while multimodal resins combine ionic, hydrophobic, hydrogen-bonding, and other aromatic interaction mechanisms to enhance selectivity and process robustness. These technologies enable effective impurity clearance across a broader range of operating conditions and facilitate the development of streamlined polishing strategies.
The performance of polishing resins is strongly influenced by critical process parameters, including pH, conductivity, and resin loading. Optimization of these parameters is essential to balance product recovery with impurity clearance and to establish robust operating spaces suitable for large-scale manufacturing. Modern multimodal resins have demonstrated particular value in reducing HCPs, residual Protein A, aggregate levels and viral contamination while maintaining high mAb recovery and preserving product quality attributes.
This presentation reviews current approaches to the development and application of ion exchange and multimodal chromatography resins for mAb polishing. Emphasis will be placed on resin selection, process optimization, and the role of advanced chromatography media in supporting efficient, scalable, and cost-effective downstream manufacturing of therapeutic antibodies.
Ensuring Comparability to Bridge Phase I and III
Overcoming Manufacturing Bottlenecks in Multispecific Design via Native Scaffold Engineering
The landscape of modern protein engineering allows for unprecedented multi-affinity designs, yet geometric complexity often comes at the cost of developability, manufacturing bottlenecks, and unpredictable in vivo mechanisms. To address these liabilities, we leveraged our years of bispecific development experience to design a novel solution that minimizes mutations while still enabling correct assembly. By retaining the structural integrity of the native IgG scaffold, this approach supports heavy-chain heterodimerization and correct light-chain pairing without compromising expression titers or stability. This presentation details the mechanism of our Lock-In platform, demonstrating how it serves as a robust, plug-and-play foundation for the predictable and scalable production of complex multispecific therapeutics.
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Seniorr Representative, ACROBiosystems
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Senior Representative, BSP Pharmaceuticals
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Reserved for Nanotemper
Unlocking the Discovery of Novel Therapeutics Against GPCRs, Ion Channels and Transporters
Discovery of Novel CD20 Antibodies via Antibody-Phage Display Technology Preserving the Native VH/VL Pairing from Immunized Animals
Economic security, resilience and defense preparedness: leveraging industrial policy to enhance Biosimilar Market Access and Sustainability
- The Critical medicines Act, the Biotech Act & Competitiveness Compass: balancing funding/incentives and new obligations
- Implementing of the New Pharmaceutical Legislation & reforming the Procurement Directive for a New Access Paradigm
- Closing the Biosimilar Void
From AI Target Discovery to Patient Clinical Response in Three Years — The IGSF8 Story
The AI: STEAD / PhialBCR. A permutation-invariant deep-learning model that learns target specificity directly from B-cell receptor (BCR) repertoires computationally assembled from tens of thousands of tumor samples — enabling concurrent target and antibody discovery without protein structure modeling or pre-existing antigen databases.
The discovery: IGSF8 as a novel innate immune checkpoint. PhialBCR prioritized IGSF8 from patient-derived antibody repertoires; orthogonal TCGA genomics and a CRISPR NK-cytotoxicity screen converged on the same target. The same AI then designed GV20-0251, a fully human anti-IGSF8 antibody, from the tumor-derived BCR pool.
The clinical readout: NCT05669430 (n=42). GV20-0251 monotherapy was well tolerated with no DLTs; in anti-PD-1 primary-resistant metastatic melanoma, 3 of 9 evaluable participants achieved confirmed partial responses (ORR 33.3%), with one response ongoing >20 months — AI target prediction to first patient clinical response in ~3 years versus the typical 10–15.
Insights from Big Data and Novel Platforms to engineer Next Generation of Antibody, Bi-and Multispecific Therapeutics
Introducing PAT into control strategies
Purification of Recombinant Pharmaceutical Proteins from Complex Feedstocks
The Science of Talent in Biopharma – Measuring Human Performance as a Strategic Asset
- Biopharma 4.0 transforms discovery, clinical, and manufacturing systems, workforce capability has emerged as a strategic differentiator. This session explores how predictive, finance-grade talent analytics can measure and optimise human performance, linking Talent Efficiency (TE) directly to productivity, quality, and financial outcomes.
- Introduces a quantitative Talent Efficiency framework applied by leading CDMOs, ATMP developers, and biologics manufacturers.
- Demonstrates how data-driven models quantify workforce readiness and return on capability investment.
- Provides a European benchmarking perspective on skills gaps, digital maturity, and the next-generation biomanufacturing workforce.
I’ve delivered Talent Science™ Boardrooms and keynotes at major global conferences including BPI (Europe & Boston), The Economist, Advanced Therapies, Bio-IT, Bio-Europe and DCAT, and would be delighted to explore how this could enhance the Festival’s strategic and leadership-focused sessions.
Key Takeaways:
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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Senior Representative, Adimab
Discovery of novel tumor derived antibody/target pairs for ADC drug development
- Creation of tumor derived antibody libraries
- Identification of novel targets based on tumor derived antibodies
- ADC proof of principle vs these novel targets
Engineering of bispecific antibody-based IL-12 mimetics with biased agonism capacities
Gene Editing CAR-T Cells to Treat Solid Tumours
High throughput analysis supporting cell line development
Learnings from latest launches of biosimilars in EU and US- Biosimilars are still a sustainable business?
Next-Generation Tumor-Specific Anti-CD30 ADC as a New Therapy in Hemato-Oncology
Scale your chromatography with confidence. A practical roadmap for column sizing, system selection, and GxP readiness
The Biotech Efficiency Gap: Why Building from Scratch is Costing the Clinic Billions
- The Lifecycle Paradox & Value DestructionBillions of R&D capital are lost annually due to poor execution and fragmented early-development capabilities.In the traditional biotech lifecycle, value is systematically destroyed when teams are disbanded after an exit or asset failure, forcing the next innovation to start from zero and waste years recreating institutional knowledge.
- The Talent Trap in BiologicsWith only 20% of assets successfully moving from pre-IND to Proof-of-Concept (PoC), the operational risk of building a high-performing team from scratch is often higher than the scientific risk.Assembling a senior, multi-disciplinary team for CMC, regulatory, and clinical operations takes years—time that most early-stage assets simply do not have.
- A New Model: Biotech-as-a-Service (BaS)The industry must shift from a "hire-and-build" approach to a plug-and-play development engine.By embedding an exit-proven leadership team—acting as operating partners rather than transactional vendors—portfolios can bridge assets from IND to PoC faster, maximizing the "dollars-into-the-clinic" ratio while providing a layer of operational risk management between capital and the clinic.
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Senior Representative, Lonza
Immunotherapy Roundtables
AI-Driven Precision Oncology: Challenges and Future Directions
CAR-T 2.0: Transitioning from Liquid to Solid Tumors
From Discovery to Developability – Ensuring Success at Any Stage
Harnessing Innate Immunity: The Next Frontier in Multi-Modal Immunotherapy
WORKSHOP: Operational Excellence: Powering the Molecule to Market Journey
Applying Nuclear Engineering Rigor to Protein Stability Prediction
Bifunctional antibody derivatives for immune system manipulation
Building Sustainable Biologics Ecosystems in Emerging Markets: From Regulation to Local Manufacturing
De novo discovery of fully human monoclonal antibodies
Developability at Boehringer Ingelheim
This talk presents Boehringer Ingelheim’s platform‑based approach to developability for biologics, supporting a broad and diverse pipeline of molecule modalities. It highlights standardized, partially automated screening work packages across upstream processing, downstream purification, and formulation development, designed to generate early, comparable insights under harmonized conditions. By embedding automation, platforming, and risk mitigation into early CMC activities, this approach enables data‑driven candidate selection, improves predictability, and lays a robust foundation for efficient, scalable manufacturing strategies.
Gene therapy for kidney disease
MCC process implementation - from batch to continuous
The Evolving Landscape of Next-Generation Antibody–Drug Conjugates
Antibody-drug conjugates (ADCs) are a rapidly expanding class of targeted therapeutics that combine the specificity of antibodies with potent payloads. Advances in antibody engineering, linker chemistry, and payload design have enabled the development of next-generation ADCs with increased versatility. This presentation will provide an overview of emerging ADC modalities, including conventional cytotoxic ADCs, bispecific ADCs, unconventional ADCs incorporating novel payloads, and immunoconjugates designed to modulate biological responses.
Trispecific eFab-eIg T-cell engagers using the eIg technology
ADCs for Immuno-oncology
Age-Related Macular Degeneration and Diabetic Macula Oedema in low and middle-income countries: policy & practice options for medicine formularies
Developing Avidity-driven Tumour Selective Multispecific Antibodies
Impurity control in complex monoclonal antibody purification via next-generation resins
A new wave of monoclonal antibody therapeutics is in development that utilize complex molecular structures as a route to enhanced efficacy. These challenging molecules require new synthetic pathways for their creation, pathways that present unique purification challenges which must be overcome for commercial viability. Increasingly, the choice of affinity resin in the purification workflow is critical to obtaining viable results that can be scaled to commercial volumes. This presentation describes how the unique features of modern affinity resins can be leveraged to create robust purification workflows for even the most challenging molecules.
Novel Multi-Payload ADCs Assembled in One Step from Native Antibodies show High Efficacy and Tolerability in vivo
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Senior Representative, Genscript
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Senior Representative, Lonza
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Senior Representative, Abzena
A bioinformatics, AI, and ML-based TCE target discovery platform
Breaking the half-life ceiling: Novel pH-dependent FcRn-binding Nanobody® molecules enable superior pharmacokinetics and broad therapeutic applications
Improving pharmacokinetics (PK) remains highly relevant for enabling flexible and patient‑centric therapies. Our novel pH-dependent Nanobody® molecules target a unique epitope on the neonatal Fc receptor (FcRn) that does not compete with albumin- or Fc-binding sites. We harness this non-competitive binding mechanism to achieve significantly improved PK properties across multiple therapeutic modalities. In a complementary application, we exploit our FcRn-binding Nanobody® domain to improve on existing FcRn antagonists. Our studies and subsequent human simulations provide compelling evidence that the enhanced potency of our molecules could translate into meaningful clinical benefits
Clinical development, regulatory considerations, and long-term safety and efficacy challenges for gene therapies in hemoglobinopathies
Platform process for downstream processing of viral gene therapy vectors and vaccines
- Overview gene therapy vectors, their size andtheir biophysical properties
- General overview of downstream processing gene therapy vectors and viruses
- Unit operations for downstream processing of gene therapy vectors
Playing by the same rules? Physicochemical developability profiling is generalisable across antibody modalities
- We recently developed a workflow to help rationalise mAb developability screening, grouping assay variables together and ranking developability profiles.
- To test how applicable our approach is to newer modalities, we have constructed a panel of 42 antibody therapeutics, derived from clinically relevant sequences, then subjected these to an array of 20 developability assays.
- Our results show that newer formats exhibit unfavourable biophysical behaviour compared to canonical IgGs, exacerbated by problematic variable domain sequences. Our workflow identifies a consensus set of physicochemical features shared by antibodies, which should help focus efforts during early developability screening.
Regulatory Reliance as a Catalyst for Biologics Access in Emerging Markets
As the global landscape of biologics evolves, many regulatory authorities in emerging markets face the challenge of balancing rigorous safety assessments with the urgent need for patient access. This presentation explores how regulatory reliance pathways, where authorities leverage the assessment work of mature agencies can serve as a critical bridge. We will examine how this strategy enables patients to receive life-saving treatments while providing emerging agencies the time, framework, and collaboration opportunities needed to build their own robust, sustainable regulatory capacities.
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Senior Representative, Icosagen
Utilizing AI/ML in monoclonal antibody discovery
Views from the ground up: changes to Phase III and its actual impact
Advancing the Development of Biologics with NAMs
Approaches to improve myeloid effector cell recruitment
Biosimilars opportunities in LMI countries: is this the future of biosimilars?
Implementing new technologies for continuous downstream processing
Novel platform of glycoengineered sEV for superior drug delivery and gene therapy
Panel Discussion: Skilful handling of pricing strategy/market access-related challenges
Targeted killing of HER2 overexpressing cells by Single domain antibody-based TNFR1 mimetics
Unveiling the PanCancer potential of dual-mechanistic uPAR-targeting ADCs across cancers
Antibody-cytokine Fusions for Cancer Therapy: Late-Stage Clinical Results
Bridging the Developability Gap
Engineering biologics to cross targeting extracellular and intracellular markers
From Global Innovation to Regional Impact: Creating Healthcare Opportunities for Latin America's Specialty Care Biologics Market
1. Latin America's biologics landscape: complexity and opportunity. Understanding the region's unmet healthcare needs, the growing role of biosimilars as cost-effective alternatives, and the unique challenges of navigating diverse regulatory and market environments.2. A strategic framework for market entry and expansion. Exploring how global innovation can be translated into regional impact through three key levers:regulatory timing, market access strategies across public and private systems, and sustainable pricing models in dynamic markets.3. Collaboration models that drive sustainable access. Examining successful partnership models that have enabled the adoption of high-regulation biosimilars across multiple markets — delivering measurable savings for healthcare systems and payers, achieving first-to-market positioning, and expanding patient access to specialty care therapies previously unavailable in the region.
Next generation of carboneous nanocarrier for light-controlled siRNA delivery
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Reserved for Heidelberg Pharma
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Senior Representative, Novartis Contract Manufacturing
Clinical Trials Roundtables
Can and should patient input be measured?
Clinical Study Protocol Complexity
Translating immunogenicity risk assessment into the clinic
The pivotal role of regulated bioanalysis in biotherapeutics development and approval
Accelerating Breakthrough Innovations in Healthcare
Brain Pretargeted PET. New Horizons to Image CNS Targets with Monoclonal Bispecific Antibodies
Bridging developability gaps
Challenges in utilizing recombinant counterparts of endogenous targets when assessing interference during bioanalysis
Cytokine-based precision therapeutics addressing todays unmet medical needs in infectious diseases, oncology and autoimmunity
Drug conjugates targeting HER2 based on engineered affibody molecules
Integrating AI/ML into Biologics Discovery: Design, Optimization, Developability, and Immunogenicity
Leveraging Fungal Precision Fermentation to Break Cost Barriers and Enable Global Access to Biologics
The high cost associated with manufacturing biologics calls for alternative production platforms that can challenge current paradigms in the pharmaceutical industry. Filamentous fungi are evolutionarily optimized for high-titer protein secretion and while biotechnological workhorses likeTrichoderma reeseihave a decades-long track record in the biofuel, textile, food, detergent, and animal feed industries, their potential for manufacturing of biologics remains largely untapped. We are leveraging the available molecular toolkit forT. reeseito develop next-generation cell factories capable of secreting dozens of grams per liter of heterologous proteins with human-type glycans. This presentation will outline technoeconomic and life cycle assessment data for production of biologics inT. reesei, alongside case studies for production of a human IgA fragment, a plasma protein and an IgG monoclonal antibody currently in development for a high-burden infectious disease. Beyond technical feasibility, our work positions filamentous fungi as a disruptive, low-cost and viable chassis for the production of biologics using processes that are compatible with global access to life-saving treatments.
Room temperature formulation of freeze sensitive biologics
- Next generation therapies (AAv, cell therapies) are the future of oncology
- Widespread delivery and acceptance also relies on innovative handling, shipping and preservation technologies
- In this talk we introduce proof-of-concepts of a solid-state technology, enabling the room temperature preservation of advanced biologics, from ADC to living cells
Targeting the inhibitory FcγRIIB (CD32B) checkpoint to enhance cancer immunotherapy
Beyond the Kozak sequence: an extended translation initiation sequence (eTIS) for higher-yield, higher-fidelity protein expression
Expression platforms optimize vectors, host cells, UTRs and codon usage, yet translation initiation, a rate-limiting step in protein synthesis, is still guided by the 40-year-old Kozak consensus sequence, a short sequence flanking the start codon. Here, using massively parallel reporter assays, machine learning and high-resolution structural analysis, we identified a greatly improved start-codon sequence grammar: the 'extended translation initiation sequence', or eTIS. eTIS-guided mRNA design improves start-codon recognition to >99%, strongly suppresses off-target protein production and increases protein output without changing the encoded protein. Across therapeutic protein and vaccine-antigen constructs, we observe typical expression gains of 15–40%, with several-fold gains in some cases. This talk will discuss the mechanism of eTIS-driven translation initiation and how eTIS can be integrated into biologics expression workflows to improve yield and product quality.
Clinical application of HLA peptidomics for precision immunotherapy
Developability of antibodies: challenges and future directions
The rapid expansion of antibody-based therapeutics has intensified the need for robust and predictive developability assessment to ensure a successful transition from discovery to clinical development. Developability encompasses the evaluation of key biophysical and biochemical properties of antibody candidates, including stability, solubility, aggregation propensity, and manufacturability. Despite significant advances in screening technologies, a considerable proportion of otherwise promising candidates continue to fail at later stages due to suboptimal developability profiles.
This presentation will explore the major challenges associated with antibody developability, including the limited predictive power of early-stage screening workflows, the inherent complexity of forecasting long-term stability, and the influence of formulation and environmental conditions on molecular behaviour. Particular attention will be given to the interpretation of biophysical datasets and their effective integration into decision-making processes, especially within a CRO context.
A central theme of this talk will be the urgent need for more standardized, scalable, and predictive methodologies to improve data comparability and decision confidence across programs. Greater adoption of plate-based, high-throughput, and automation-compatible platforms will be highlighted as a key step toward enhancing robustness, reproducibility, and throughput in early developability assessment. In parallel, emerging trends underscore the growing impact of advanced bioinformatical tools and in silico approaches, including sequence- and structure-based analytics, molecular modeling, and the application of machine learning algorithms for predictive developability. Recent advancements in AI-driven models enable improved prediction of stability, aggregation propensity, and manufacturability, supporting more informed candidate selection. Combined with expanded assay portfolios tailored to increasingly complex antibody modalities, these innovations are driving the establishment of standardized, fit-for-purpose strategies aligned with evolving industry needs.
Overall, this presentation aims to provide practical insights into current best practices, identify existing gaps, and outline innovative solutions shaping the future of antibody developability in biologics research and development.
How LensAI Uses a Biology-Native Context Layer in Drug Discovery
Biologics discovery has become one of the most data-rich environments in life sciences, spanning decades of program histories, assay results, structural data, multi-omics outputs, ELN records, and competitive intelligence across hundreds of targets and therapeutic areas. The challenge is not a shortage of data. It is that the infrastructure built to store it was never designed to reason across it. Sequence results, assay outputs, structural models, ELN records, and competitive intelligence are generated across different systems, stored under different identifiers, and shaped by the conventions of the teams that produced them. Standard integration makes data accessible, but accessibility is not the same as computability. Reasoning over biology requires the relationships between records, and when those relationships are implied rather than represented, they must be reconstructed from scratch on every project. At the scale most discovery organizations operate, that reconstruction cost compounds across programs, teams, and therapeutic areas. A representation that loses provenance as it harmonizes is not usable in discovery, no matter how well it performs on a benchmark or how capable the model reading it is. This is the gap MindWalk built ReefIQ™ to fill. ReefIQ™, the governed biological context layer, is powered by HYFT® Technology, MindWalk's biology-native representation engine that links sequence, structure, function, pathway, and literature into a single connected language. ReefIQ harmonizes an organization's discovery data against that representation without flattening the original records or losing provenance. Above it, LensAI™, MindWalk's reasoning and workflow layer, retrieves and reasons over governed context directly, rather than reconstructing it from fragmented records. This session shows what becomes reachable when reasoning runs over governed, computable biology, and how to evaluate it on your own data without disrupting the systems you already run.
Panel Discussion: Finance & Investment for Start Ups
Selective Human Receptor Modulating Peptides for GPCR agonism and antagonism
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An Oligonucleotide Program in Late-Stage Clinical Trials
This abstract describes the experience gained with the life‑cycle management of the Inclisiran Anti-Drug Antibody (ADA) assay, covering regulatory‑driven assay optimization and validation followed by the ADA assay transfer to a strategic partner.
The increasing use of oligonucleotide‑based therapeutics has heightened regulatory expectations for robust immunogenicity assessment throughout the clinical program. Therefore, Anti‑drug antibody (ADA) readout represents a critical component of clinical development and long‑term safety monitoring.
Inclisiran is a GalNAc‑conjugated double‑stranded siRNA, targeting hepatic PCSK9 mRNA, leading to sustained reduction of Low-density lipoprotein (LDL) Cholesterol in circulation. Following FDA approval, a Post‑Market Commitment (PMC 4186-4) required the introduction of an affinity‑purified positive control. In parallel, supply shortages of ADA assay plates necessitated evaluation of alternative assay formats to support an expanding clinical program with a global footprint.
A partial revalidation, was successfully completed, demonstrating increased ADA assay sensitivity and improved drug tolerance. The updated assay was subsequently transferred to enable high‑throughput analysis of study samples from late-stage clinical trials.
Bridging the Translational Gap: A New Ecosystem Approach to De-risking CMC and Tech Transfer
Engineering novel tetraspecific t cell engagers
From Code to Cure with Unigen AI/ML Platform: Compugen Advance the Next Generation of Cancer Immunotherapies
From Tumors to Neurodegeneration: Reconstructing Disease Dynamics with Multimodal AI
Neurodegenerative diseases and cancer, despite their differences, share a fundamental challenge: both are complex, dynamic processes driven by heterogeneous and often latent biological mechanisms. In both domains, artificial intelligence has been widely applied, yet many current approaches remain largely correlative, limiting interpretability and clinical impact.
In this talk, we present a multimodal AI framework designed to integrate imaging, molecular, and clinical data to model disease dynamics over time. Originally developed in oncology to characterize tumor behavior at both local and systemic levels, this approach is here extended to neurodegenerative diseases, where long temporal evolution and subtle biological changes pose additional challenges.
The framework focuses on capturing latent biological processes, enabling the identification of patterns not directly observable through standard clinical assessment. We will discuss how this paradigm supports clinically relevant tasks such as early detection, patient stratification, and prediction of disease trajectories, while maintaining interpretability and alignment with known physiological mechanisms.
Finally, we explore how such models can move beyond prediction toward hypothesis generation, bridging domains and providing a unified perspective on complex diseases, with implications for more personalized and adaptive therapeutic strategies.
IgG glycans as biomarkers
PANEL DISCUSSION: From Contract to Collaboration: Effective CDMO Strategies for Biopharma Manufacturing
Aligning strategic relationship management, manufacturing science, and CDMO execution
· Technology Fit and Platform Compatibility
· Transferring Process Knowledge, Not Just Methods
· Process Robustness, Scalability, and Lifecycle Thinking
· Managing Change in a Science-Driven Environment
· Enablers: Governance Models That Support Technical Excellence
The SGC and Target 2035: Generating Proteins and Ligands to Enable Machine Learning
- The SGC is an international public-private partnership with a mission to accelerate the discovery of new medicines through open science.
- Target 2035 aims to develop pharmacological modulators for every human protein by 2035 to provide tools to enable a better understanding of biology.
- In the next 5 years, SGC will generate and share protein-ligand datasets, enabling AI and machine learning to expedite the mission of Target 2035 more effectively and efficiently.
Biomarker potential of circulating methylated cfDNA signatures
Expression of novel therapeutics through moss-based platforms
Extended Q&A - ask the investors
Particle Shedding from Infusion Bags: Characterization and Emerging Concerns for Therapeutic Proteins and Patients
Responsible AI agents for toxicologic pathology and non-clinical safety in drug development
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Create your personal agenda –check the favourite icon
Fine-tuning Affinity and Selectivity of an anti- PD-L1 Antibody through Deep Learning-guided affinity maturation
Radiotherapy and the Tumor Microenvironment
Technology transfer strategies: working with external partners for cell therapy production
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Evolving trends in biosimilar clinical trials
Inducing antigen-specific immune tolerance with chimeric non-classical HLA molecules inspired by pregnancy
Scaling the Future of Cell & Gene Therapies: From Scientific Innovation to Sustainable Platforms
Cell and gene therapies have reached an important inflection point. While early commercial successes have demonstrated the clinical potential of these technologies, the next challenge is creating scalable, sustainable platforms capable of supporting increasingly diverse therapeutic modalities.
This presentation explores how organizations can move beyond product-by-product execution to develop integrated technology, operating and manufacturing platforms that accelerate innovation, improve resilience, and enable long-term portfolio growth. Drawing on experience across commercialization, strategic operations and advanced therapy deployment, the session will discuss the leadership decisions required to bridge scientific innovation with industrial scalability.
Engineering Tomorrow’s Therapies Today: A GMP Hub for Biologics & ATMP Acceleration
This presentation will cover a multimodal facility offering aseptic manufacturing services for biotech and ATMP products. The main focus is a new concept designed to accelerate launch readiness and streamline technology transfers.
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Senior Representative, SKAN
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A Universal AI Design Framework and Brokerage Platform for Democratised Manufacturing of mRNA Therapeutics
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Senior Representative, Lonza
Engineering CHO cell lines for improved efficiency and productivity
Sabah as the Borneo Reservoir for Non-Cannabis Phytocannabinoid Derivatives and Mimics in Next Generation Biologics Development
The discovery of next-generation biologics increasingly depends on identifying novel, high-affinity bioactive molecules from complex natural systems that can be translated into safe, scalable therapeutic platforms. While global drug discovery has traditionally focused on established geographies and synthetic pipelines, emerging biodiversity reservoirs offer untapped opportunities for biologics innovation. This presentation introduces Sabah, Borneo as a strategic reservoir of non-Cannabis phytocannabinoid derivatives (PD) and cannabinoid-mimetic compounds (PM) with therapeutic relevance. Using an integrated discovery pipeline combining hyphenated analytical platforms (LC-MS/QToF-NMR), computational molecular dynamics, and bioactivity-guided screening, we have systematically mapped Sabah native plant species with cannabinoid-like pharmacological profiles. To date, 22 species have been identified to contain PD or PM compounds structurally and functionally related to cannabidiol (CBD), cannabinol (CBN), N-acylethanolamines, β-caryophyllene, and flavonoid-based mimics such as kaempferol. Importantly, selected species including Trema orientalis and Rhododendron rugosum offer a legally compliant, non-psychoactive, and sustainable alternative to Cannabis sativa, addressing regulatory, safety, and supply-chain challenges faced in many jurisdictions. We will present pre-clinical in vivo data on a PD/PM-based formulation targeting antinociception and neurogenic pain, alongside early translational insights relevant to metabolic, anti-infective, and inflammatory indications. The session will conclude with a roadmap for biologics translation, outlining OECD GLP-aligned pre-clinical workflows and NPRA/MOH regulatory readiness in Malaysia, positioning the Borneo reservoir as a scalable and globally relevant pipeline for next-generation antidiabetic, antibacterial, and analgesic biologics.
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Clinical development of Biosimilars: Lessons From 2025
Every disadvantage has its advantage
Spatial Transcriptomics in Solid Tumor Immunology
Ubituin modified proteomic approaches to CHO lines
Local substrate and response to local immunotherapy with InC01, compartment-locked IL-12
Analytical approaches for developing clinic ready multispecifics antibodies
Bioassays for Biologics: Modalities, Challenges and Best Practices
CD28bsAb reinforce T cell function and overcome anergy in CD3bsAb-treated patients
Charge Variants characterization of a noncovalent dimeric fusion protein
- Charge variants characterization is a fundamental step in biopharmaceutical development.
- For non-antibody-like compounds, limited literature and platform knowledge are available, making method development and data interpretation particularly challenging.
- This talk describes the charge variant characterization of a noncovalent dimeric fusion protein, highlighting specific challenges and key differences compared with monoclonal antibody analysis.
CUE-401: A Novel IL-2/TGF-beta Fusion Protein for the Induction & Expansion of FOXP3+ Regulatory T Cells
Disrupting Peptide Therapeutics: Numaferm’s Numaswitch Platform for Sustainable, Scalable, and Scarless GLP-1 Analog Manufacturing
Endpoint Selection as a Determinant of Reimbursement Success
Positive trial results do not automatically translate into positive reimbursement decisions. Increasingly, the determining factor iswhatwas measured, not justhow wella treatment performed.
This presentation explores endpoint selection as a critical driver of reimbursement success, examining how misalignment between clinical trial endpoints and payer evidence needs can undermine coverage decisions. Using recent reimbursement and HTA examples, it highlights why certain endpoints fail to convince decision-makers and identifies features of endpoints that support favourable assessment, such as clinical relevance, patient meaningfulness, and suitability for comparative and economic evaluation.
By positioning endpoint selection as an early strategic decision with downstream access consequences, this talk aims to help stakeholders design trials whose results are not only positive, but reimbursable.
Extroducer: a minimally invasive targeted delivery device
Platform technology: status quo in the area of novel biological entities
Expectations, perspectives and benefits for different modalities, incl. key elements of a successful technology platform
- Examples and real benefits of using platform technologies for different types of biologics
- Expectations and anticipated benefits towards platform technologies in the future
- Key elements of a real technology platform
- Current examples from their daily business for platform development initiatives, incl. aspects of stakeholder commitment and project priority
Rethinking Immunogenicity Risk: Integrating Tolerance, ML, and Human Insights
Immunogenicity remains a challenge when developing novel biotherapeutics. In silico approaches primarily evaluate immunogenic potentials by predicting HLA ligands. However, not all predicted T cell epitopes result in immune activation, requiring additional screenings to assess immune tolerance and refine immunogenicity analyses.
We introduce here an update to our JanusMatrix algorithm, first designed to assess cross-conservation between therapeutic-derived epitopes and epitopes from the human proteome. JanusMatrix 2.1 enhances assessment of tolerance by integrating expression and prevalence information into a new ML-based model. This new analysis enables the adjustment of immunogenic potentials based on total foreign – non-tolerated – epitope content.
JanusMatrix-adjusted immunogenicity scores provide a better alignment with clinical observations. These improvements were integrated into a new model predicting anti-drug antibody (ADA) responses, leading to a 7-fold increase in the correlation between predicted and observed ADAs, and with over 75% of predicted ADAs falling within 10% of observed values.
A Single Punch to Rewire Immunity: Reprogramming the Tumor Microenvironment via Metabolic Intervention
Analytical Strategy for Therapeutic Synthetic Peptides: From Development to Quality Control
- Designing an analytical strategy across the peptide lifecycle in line with regulatory expectations
- Key peptide-specific analytical challenges and solutions
- Bridging development methods to robust QC implementation
Closing the Analytical Gap: A Rapid Fluorescence Activity Assay for Polysorbate-Degrading Enzyme Risk in mAb Drug Substances
Enzymatic polysorbate degradation is a recurring cause of biologics stability failure, driven by host-cell lipases and esterases that co-purify with the antibody at sub-ppm levels. Total HCP by ELISA can pass release spec while these enzymes stay active, and LC-MS names the species present without showing which are catalytically dangerous at formulation pH. This talk presents a high-throughput fluorogenic activity assay, qualified across five drug-substance matrices at pH 4.0 to 6.5, that detects and ranks active enzymes in the sub-ppm risk zone. Using a biosimilar IgG1 case study co-developed with Sandoz, we show a 33% polysorbate-80 loss that passed ELISA, resolved by inhibitor fingerprinting to identify the dominant active driver and a latent acidic-excursion risk.
Regulatory compliance for analytical methods: frameworks and guidelines for QA/QC
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Senior Representative, Datwyler
Unraveling CD4 T-Cell Responses to Therapeutic Antibodies through TCR Sequencing: A Novel Approach to Immunogenicity Risk Assessment
A generic strategy for the conditional activation of therapeutic antibodies
A High-Throughput, Free-Solution Screening Platform for Ternary Complex Assembly: From One Health Diagnostics to Next-Generation Therapeutics
Conventional solid-phase ELISA workflows for antibody characterization and pair selection are often costly, reagent-intensive, and time-consuming. To address these limitations, we introduce Spectral Shift Technology (SST), a sensitive fluorescence-based platform that quantifies biomolecular interactions through sub-nanometer emission wavelength shifts under native, free-solution conditions. SST enables rapid assessment of affinity and binding compatibility, facilitating identification of productive ternary complexes in a miniaturized, automated high-throughput screening (HTS) format. As a proof of concept, SST was used to rapidly select anti-FeLV p27 monoclonal antibody pairs recognizing distinct epitopes. The platform identified compatible antibody combinations capable of simultaneous target engagement, forming stable ternary complexes for downstream assay development. Compared with conventional workflows, SST achieved up to a >100-fold reduction in sample consumption and reduced characterization time from overnight protocols to less than one hour. Selected antibody pairs outperformed commercially available benchmark anti-FeLV p27 antibodies and were successfully translated into a highly sensitive prototype lateral flow immunoassay (LFIA). These findings establish SST as a rapid, reagent-efficient platform for high-throughput biomolecular interaction screening and functional ternary complex discovery. Beyond antibody pair selection, SST offers a scalable framework for accelerating One Health diagnostic development and supporting next-generation biologics, with potential applications in quality control across research, manufacturing, and clinical development.
CMOs as Strategic Partners: The Evolving Landscape of Fill-Finish in Commercial Biologics
High-performance separation of mAb proteoforms by CE-MS on the intact and subunit level for ultrasensitive charge variant characterization
Integrating multiparameter PAT sensors with smart labware to enable high-throughput, upstream microbioreactor screening tools
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Bioprocessing 4.0: From Data Infrastructure to Autonomous Biomanufacturing
- Shift from fragmented, one-way data capture to FAIR, reusable, and value-driven data assets is the prerequisite for everything that follows.
- Autonomous laboratories are no longer theoretical as knowledge-centric, self-optimising process development approaches evolve
- Technology alone is insufficient and better alignment between biopharma, CDMOs, tools providers, and investors is needed to move beyond pilots across the industry.
Clinical Batch Release and ICH Stability Compliancy
Drug innovation and patient engagement: learning from risk communication science
How LNPs Change Under Stress: Analytical Insights for Translational mRNA Medicine
- Antibody Engineering using Machine Learning assisted Yeast Surface Display enables affinity maturation of an immune checkpoint blocker with low sequence intrusiveness.
- Deep Learning models are trained on context specific biological data to infer new variants not observed by sequencing and accurately predict their properties.
- in vitroantigen binding andin vivotherapeutic assessments confirms the efficacy of the approach.
Immunogenicity Publication Bias and Its Consequences for Predictive Models: A Call for Transparent Reporting
Moving away from Acetonitrile and TFA to greener eluents in Biopharma LC-MS
Non-clinical immunogenicity risk assessment for biotherapeutics
Scalable production of 3D in vitro models using hydrogel microbead technology
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3D in vitro models for drug screening
A novel -in-1 formulation liquid handler for high-throughput screening
Antibody Sequencing And Screening Technologies
Attenuated cytokine antibody fusions for enhanced anti-tumor activity
Automation and high throughput platforms for cell therapy production
Development of Novel Ultra-Long Acting GLP-1 Analogues for Diabetes and Obesity
Integrating T-Cell Epitope Prediction and Population-Level Immunogenicity Assessment for ADA Risk Profiling in Biologic Drug Design
Step-Wise Optimization of a Next Generation FcRn Inhibitor Fused to an Albumin-Binder for Improved IgG Clearance
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Applying AI to Overcome in vivo Barriers to Targeted Delivery
Closing Panel Discussion: Advanced Therapies in 2026 – Success, Challenges, and Opportunities
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