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Programme
Day
From Model To Medicine: Fixing The Translation Gap
Panel Discussion Conference Room 1• Are we building better models—or just more complex ones?
• Replacing or reducing animal models
• Achieving regulatory compliance
• Achieving Pharma buy in.
Reduction Of Animal Bi-Products In Cell Cultures
Industry Presentation Conference Room 1• Fetal Bovine Serum (FBS) is widely used in cell culture but is associated with sustainability, cost, and experimental variability challenges.
• We evaluated two chemically defined serum alternatives.
• Later we assessed cell growth across 70+ adherent and suspension cell lines in reduced serum.
• Growth was comparable in all lines using 5% versus 10% FBS. Consistency was maintained across multiple FBS batches.
• These findings support reducing serum concentrations, therefore we are transitioning away from 10% serum.
Manufacturing Next-Generation Therapeutic Modalities
Panel Discussion Conference Room 2• Synthetic products, emerging & new modalities.
• How can manufacturing systems be rapidly adapted for highly synthetic products?
• Progressing forward to stable cell lines and what tech is needed?
From Delivery To Tumor Control: Designing Preclinical Studies For In Vivo CAR-T Therapies
Solution Provider Presentation Conference Room 1In vivo CAR-T therapies are emerging as a promising approach to engineering immune cells directly within the body, potentially overcoming some of the manufacturing, scalability, and accessibility challenges associated with conventional ex vivo CAR-T approaches. However, demonstrating successful delivery alone is not sufficient to establish therapeutic potential. A preclinical evaluation strategy must connect delivery and CAR expression to functional immune-cell activity, antitumor efficacy, and safety considerations.
This presentation will explore a question-driven framework for designing preclinical studies for in vivo CAR-T therapies, from selecting appropriate delivery systems to characterizing tumor control. Particular attention will be given to the complementary roles of immunodeficient and humanized mouse models in addressing different biological questions. The presentation will discuss how to distinguish delivery-related limitations, identify common pitfalls in efficacy evaluation, and integrate mechanistic and pharmacodynamic endpoints into study design. It will also address the limitations of individual mouse models, and the challenges of evaluating human-specific therapeutic components in vivo.
Ultimately, the goal is to provide cell therapy developers with a practical framework for selecting fit-for-purpose preclinical mouse models to guide the development of in vivo CAR-T candidates from initial proof of concept toward more robust translational assessment.
What’s Next For Cell And Stem Cell Therapies? Challenges, Opportunities, And Clinical Translation
Roundtable Discussion Conference Room 1• Bridging discovery and the clinic: how AI is transforming translation in cell and stem cell therapies.
• Enhancing therapeutic efficacy through AI-driven design and combination strategies.
• Scaling manufacturing with automation, AI, and smart bioprocessing.
Ingenza Presentation
Solution Provider Presentation Conference Room 1Towards A Complex In Vitro Model Of Fatty Liver Disease
Industry Presentation Conference Room 1Getinge Presentation
Solution Provider Presentation Conference Room 2Human Brain Organoids In Drug Discovery
Industry Presentation Conference Room 1• Brain organoids are a biomedical revolution mimicking brain development and function, and they are scalable for high-throughput patient-specific neural network screening.
• This presentation covers a:head bio’s brain organoid-based drug discovery efforts.
Closing The Gap: Connecting Upstream And Downstream Bioprocessing In Cell-Based Therapies
Panel Discussion Conference Room 2• Upstream decisions that break downstream processes
• Data continuity across the process
• Designing for end-to-end process robustness
• Automation strategies for scaling up manufacturing
Protein Impurities In Cell And Gene Therapies: Regulatory Expectations And LC-MS Best Practice
Solution Provider Presentation Conference Room 2Protein impurities in cell and gene therapies arise upstream but surface downstream, affecting quality and patient safety. Regulators now expect impurity analysis from early development, using LC-MS for complex protein profiles that challenge ELISA.
Analytics at the Pace of the Process: Rapid HCP, Titre and AAV Quantification for Upstream & Downstream Development
Solution Provider Presentation Conference Room 2Upstream and downstream decisions often wait on analytical results. We show how Amperia quantifies titre, host cell proteins and AAV from any matrix, matching existing analytical methods with far less hands-on time and cost.
Human Retinal Organoids In Gene Therapy Development
Keynote Conference Room 1This talk will summarize the latest developments in retinal organoid technology and provide examples of their applications in disease modelling and AAV vector development.
The AI Native Bioprocessing Platform
Solution Provider Presentation Conference Room 2As biopharma organizations scale from development to manufacturing, disconnected QC and bioanalytical data create bottlenecks and rework. In this session, I'll show how a connected digital thread — linking QC LIMS with bioanalytical and process (BioA/P) data — closes the gap between R&D, process development, QC, and manufacturing.
Drawing on real-world deployments, I'll discuss how standardizing scientific workflows across ELN, LIMS, and scientific data management improves data integrity and traceability, accelerates technology transfer, and builds a scalable digital foundation that supports AI-driven insight and regulatory-ready, next-generation biomanufacturing.'
Enabling Affordable Gene Therapies Through Continuous Viral Vector Manufacturing
Industry Presentation Conference Room 2CGT Catapult has developed an intensified rAAV manufacturing process at 2L scale by integrating perfusion-based upstream continuous harvest with downstream continuous purification. Improvements include:
• 5-fold higher viral genome titre
• ~20% increased packaging efficiency
• ~70% relative improvement in viral downstream recovery
• Reduced waste and downstream labour
Digital Twin Modelling For Accelerating Technical Transfer For Upstream Processes & As Digital Shadows In Commercial Manufacturing
Industry Presentation Conference Room 2Digital twin modelling is a simulation of active cell culture operations based on process understanding, first principles and historical and real time data. During the presentation you will:
• Identify critical data inputs for building reliable digital twin models for cell culture processes
• Use the tool to forecast the impact of process parameter changes, optimize sparger selection, and define gassing control strategies during technical transfer and scale-up
• Minimize at-scale technical runs during transfer through case study examples from Sanofi
• Verify PPQ batch consistency against historical CTM batches in real-time
• Quickly identify root causes and implement corrections when abnormalities arise
• Transition toward real-time optimization and disturbance rejection to reduce batch-to-batch variability and achieve optimal productivity and quality
Patient Derived Cells As New Approach Methodologies For More Predictive Oncology Models
Industry Presentation Conference Room 1• Establishing a PDC biobank: Practical considerations in tissue acquisition, model establishment and the development of a diverse, clinically relevant model collection
• Quality control and characterisation: The challenges of maintaining tumour heterogeneity, ensuring model reproducibility and selecting fit-for-purpose models for drug discovery
• 3K Accelerator Programme: Applying patient-derived models to support drug repurposing and the identification of promising therapeutic opportunities
• Digital twins: Exploring the integration of experimental data and computational modelling to improve predictive capabilities in preclinical research.
• ValiRx Animal Health: Extending patient-derived modelling approaches into veterinary oncology and exploring opportunities in comparative oncology
The presentation will highlight both the practical challenges of developing robust patient-derived models and their potential applications in advancing more predictive and translationally relevant drug discovery.
Stem Cell-Derived Organoid Research Supporting Advanced Therapies
Industry Presentation Conference Room 1• Human 3D cultures and organoids became indispensable New Approach Methodologies in therapy development
• iPSC-derived human 3D organoids provide useful in vitro preclinical models for advanced drug research and development
• Specific disease models from gene-edited human pluripotent stem cells can be generated
• For regulatory acceptance of human organoid based preclinical drug development a GLP environment is required
rAAV Production Process Intensification Using Perfusion Bioreactor Technology
Industry Presentation Conference Room 2Minimised Process Development By Recombinase Based Targeted Insertion For Superfast Clone Development Allowing Prefabricated Manufacturing Process
Industry Presentation Conference Room 2Advancing CGT Scale-Up With Animal-Free Reagents: From Dissociation To Expansion
Solution Provider Presentation Conference Room 1Build scalable CGT workflows with animal-free recombinant reagents. Explore how recombinant insulin and TrypsiNNex® can support controlled, consistent and scalable CGT processes. Make cell dissociation more predictable. Learn how animal-free recombinant TrypsiNNex® enables effective MSC dissociation while maintaining high cell viability and a stable phenotype across passages. Optimize cell culture and product yield. Discover how Recombinant Insulin can support cell expansion and productivity in serum-free media for CGT applications.
Support cell growth while preserving pluripotency. See how fine-tuning insulin supplementation improved iPSC proliferation, morphology and attachment, while preserving stemness.
Connect process performance with scale-up readiness.
Explore how consistent dissociation, serum-free cell expansion and tunable insulin supplementation can improve reproducibility and facilitate CGT scale-up.
Informed Clone Selection Through Integrated, CQA-Driven Decision-Making In Early Cell Line Development
Solution Provider Presentation Conference Room 1Early clone selection typically relies on clonality, growth and productivity, but these measures provide only a partial indication of suitability for downstream development and scale-up.
This presentation describes an integrated workflow performed on a single benchtop instrument, broadening early clone assessment beyond these established criteria. Beginning with single-cell seeding and image-based evidence of clonality, the workflow tracks clonal outgrowth while integrating cell count, viability and confluence with Fc or Fab titre. These linked measurements enable normalised titre and specific productivity calculations, while early glycan screening introduces product quality attributes before scale-up.
Connecting all measurements at clone level enables conditional triage across clonality, growth, productivity, product quality and scalability potential. Automated analysis, traceability and clonality reporting reduce reliance on manual data handling.
By generating this comprehensive evidence base on a single platform, the approach supports earlier, more informed selection of clones better aligned with downstream development and successful scale-up.
Choosing the Clone That Scales: Process-Controlled, Fed-Batch Screening of 96 Clones in Parallel with the Cydem VT Automated Clone Screening System
Solution Provider Presentation Conference Room 1Clone selection in CHO cell line development still relies largely on shake flasks and deep-well plates that poorly represent bioreactor conditions, so clones that perform well early often fail to scale. The Cydem VT Automated Clone Screening System addresses this by screening up to 96 clones in parallel in closed 3–8 mL microbioreactors with well-individual pH and DO control, automated fed-batch feeding, continuous pH, DO and biomass monitoring, and integrated cell count, viability and IgG titer measurements, enabling up to three days of walk-away operation.
Engineered Cell Lines To Enable Multi-Specific Antibody Development
Keynote Conference Room 1World Record Cell Densities: Success Stories After 2 Years Of Membrane Stirrer Bioreactors
Solution Provider Presentation Conference Room 2BioThrust's novel ComfyCell platform, based on Membrane Stirrer technology, has achieved world record process intensities for CGT & Biologics processes. Join us for learnings & results of:
- iPSC Expansion in 300 mL & 2 L: Up to 44 million cells per mL
- HEK Expansion in 2 L: Up to 93 million cells per mL
- CHO Expansion & mAb production: Up to 258 million cells per mL
CHO Process Development: Using Analytics To Optimise Temperature And Feeding
Solution Provider Presentation Conference Room 2A scientific case study showing how spent-media LC–MS, experimental design and predictive modelling guide CHO process development, informing temperature and feeding decisions to balance mAb yield and product quality.
PHCBi Presentation
Solution Provider Presentation Conference Room 2Cell Line Database Development
Industry Presentation Conference Room 1Cell, Vector And Media Engineering To Facilitate Manufacture Of ‘Difficult-To-Express’ Products
Industry Presentation Conference Room 2• Vector engineering: utilising synthetic promoters, 5’UTRs, introns and signal peptides to optimise product biosynthesis rates.
• Cell factory engineering: identifying and fixing host-cell biosynthetic bottlenecks
• Media engineering: using novel media additives to re-wire cellular function and release previously untapped biosynthetic capacity.
From Organoids to Decisions: Automated Imaging for Predictive 3D In Vitro Models
Solution Provider Presentation Conference Room 1From organoids to decisions: automated imaging converts human organoids into quantitative, longitudinal data — batch QC, safety screening, and morphometric readouts that deepen translational analyses — with cardiac, adipose, and vascular examples.
Optimizing Upstream Bioprocess Efficiency With GlucoSense - From Offline Sampling To Real-Time Glucose Optical Control
Solution Provider Presentation Conference Room 2Hamilton new GlucoSense Sensor for Cell Culture applications:
• In-Situ Optical PAT Innovation: GlucoSense integrates a mid-IR ATR sensor and a cell-exclusion membrane to ensure measurement accuracy without complex MVDA calibration models.
• Proven Analytical Precision: Validated in fed-batch and perfusion CHO runs up to 50M cells/mL, maintaining ±0.3 g/L RMSE over 21 days with minimal product calibration.
• Autonomous GMP Scale-Up & CQA Control: real-time measurements enable closed-loop feeding, suppress metabolic shifts, and stabilize mAb glycosylation profiles
Accelerating Upstream Process Development Through Data-Driven Cell Culture
Keynote Conference Room 2Lost in Translation? Developing In Vitro Models That Better Predict Multi-RNA Therapeutics
Industry Presentation Conference Room 1• Why reducing biology to simple cell models can limit our ability to accurately evaluate multi-RNA therapeutics, and how more representative in vitro systems can improve translation. I'll share some of SymphoRNA's data and insights
• Finally, I'll consider how in vitro models need to evolve if we want to generate datasets capable of supporting the next generation of AI-driven target discovery
Vector Design As The Strategic Lever In Biologics Development
Industry Presentation Conference Room 1• Vector fundamentals: Explore the anatomy of expression vectors and the regulatory elements that drive robust biotherapeutic expression in mammalian cell lines
• Integration strategies: Compare traditional random integration with emerging targeted integration and transposon-based systems, highlighting their respective strengths, limitations, and impact on cell line development timelines.
• Complex modalities and outlook: Examine vector design for complex modalities and discuss current challenges and key takeaways shaping the field's future.
Building Scalability Into Cell Culture Process Development: Integrating ATF and At-Line Analytics From An Early Stage
Solution Provider Presentation Conference Room 1Intensify your process from early development using ATF perfusion and REBEL XT at-line analytics. Gain real-time insight into cell metabolism, optimize media and feeding strategies, and establish a robust scalable pathway from process development to commercial-scale biomanufacturing.
Translational Hurdles When Switching From R&D To Clinical Manufacturing
Industry Presentation Conference Room 2The presentation explains key hurdles in translating academic cell research into clinical manufacturing. Major challenges include GMP documentation, process and analytical validation, stability data collection, cleanroom practices and regulatory compliance. Successful translation requires early planning and smart ressource allocation as well as robust documentation for a smooth submission process.
Next-Generation CHO Cell Lines: Built for Speed and Complexity
Industry Presentation Conference Room 1As CHO-expressed biologics become increasingly complex, Novartis is advancing next-generation parental, and project customized cell lines designed for higher productivity, greater stability, reduced protease activity, and improved performance with challenging molecule formats.
By combining these optimized hosts with FACS-based enrichment of high-producing clones, fast-track cloning (FTC) delivers a powerful platform to shorten cell line development and accelerate promising candidates toward First-in-Human studies.
The Future Of Engineering Cell Lines
Panel Discussion Conference Room 1• Novel approaches to cell line development:
o Technologies for targeted integration
o Transposons
• Predicting molecule characteristics with AI – customising cell lines to the new era of therapies
• Shortening timelines of cell line development, speed & performance
Use Of Temporal Profile Predictions In Cell Culture
Keynote Conference Room 2Cell culture development traditionally relies on "test-and-learn" cycles that are time-consuming and resource-intensive. This presentation explores the transition to a "predict-and-verify" framework using digital twins built on a historical dataset of >1,800 bioreactor runs. We demonstrate how live predictions of key process performance indicators including cell viability, metabolites and antibody titer support upstream process development. These predictions accelerate the path to a robust production process, scale-up, and technology transfer.
The Productivity Challenge: How Can The Industry Deliver More Medicines With Less
Panel Discussion Conference Room 2Driving Efficiency Across Modalities, Indications & Development Models
• How can biopharma improve productivity?
• How will AI transform the value chain?
• What will define industry leaders in 2030?
Engineered Cell Lines To Enable Multi-Specific Antibody Development
Keynote Conference Room 1Cell Sciences toolbox includes automation and cell line engineering platforms to enable the production, characterization and selection of multispecific antibodies
Next-Generation Cell-Based Platforms: From Bioactive Discovery To Biomanufacturing
Industry Presentation Conference Room 1Next-generation cell-based platforms are transforming nutritional biotechnology by enabling both bioactive discovery and the production of novel ingredients through cellular agriculture. Integrating human-relevant organoid models for functional screening with scalable cell-based biomanufacturing offers new opportunities to bridge mechanistic discovery, ingredient innovation, and translational development of next-generation nutritional solutions.
Workflow For Generating and Screening In Vivo-Like 3D Cancer Models Directly in Multicompartment Microwell Chips
Industry Presentation Conference Room 1• A microchip platform for generating, culturing and imaging 3D cancer models
• Imaging-based assessment of cell density and cell mixing in heterotypic tumor spheroids
• Assessment of immune cell infiltration, phenotype and cytotoxicity in 3D tumor models.
Developing In Vitro, Ex Vivo And Mouse Models Of Paediatric High Grade Gliomas For Preclinical Testing
Industry Presentation Conference Room 1We present and assess the relevance and usefulness of several models varying in the complexity. We established and characterized a panel of DMG derived cell cultures. To study their interactions with immune cells, we developed co-cultures with murine, human and human iPSC derived microglia to study and manipulated cell migration and invasion
PAT Meets Automation: Application Of Raman Spectroscopy In Cell Therapies
Industry Presentation Conference Room 2Navigating The End-To-End Bioprocessing Journey
Industry Presentation Conference Room 2Lessons Learned on the Long Journey from Academic Protocols to GMP Manufacturing: Process Optimization, Risk Mitigation, and Regulatory Readiness
Cryopreserving Cell Aggregates For Manufacturing
Industry Presentation Conference Room 2- Large scale Cellbanking is crucial for reproducible manufacturing
- Single cell cryopreservation is a labor-intensive process which carries risks
- Freezing of aggregates simplifies process and shortens seedtrain
Cell Next-Generation CHO Cell Lines: Built For Speed And Complexity
Industry Presentation Conference Room 1As CHO-expressed biologics become increasingly complex, Novartis is advancing next-generation parental, and project customized cell lines designed for higher productivity, greater stability, reduced protease activity, and improved performance with challenging molecule formats.
By combining these optimized hosts with FACS-based enrichment of high-producing clones, fast-track cloning (FTC) delivers a powerful platform to shorten cell line development and accelerate promising candidates toward First-in-Human studies.
Finding Winners Earlier: Leveraging Next-Generation Technologies to Advance Bioprocessing Research
Industry Presentation Conference Room 2Early stage research offers a unique opportunity to identify high performing clones and generate critical product and process insights before development bottlenecks emerge. This presentation explores how next-generation technologies can accelerate decision making, improve candidate selection, and embed developability, manufacturability, and scalability considerations from the outset.
Identifying The Best Starting Material For Cell Therapy - Our Experience With Cord Blood Natural Killer Cells
Industry Presentation Conference Room 1Title To Be Confirmed.
Keynote Conference Room 1Introduction To The Event, Outlining The Key Barriers To Translating Cell Therapies Into The Clinic
Optimised Cell Manufacturing Workflow To Generate CAR-T Cells From Whole Blood
Industry Presentation Conference Room 1Manufacturing From Whole Blood In A Fully Closed Work Flow (Including The CGX10)
Title To Be Confirmed.
Industry Presentation Conference Room 1CGT Investment Landscape And What Investors Are Looking For Before Investing In A New Product
T Stem Cell Memory Manufacturing For Long-Lived, High-Efficacy T-Cell Therapies
Industry Presentation Conference Room 1Clinical Trial Immune Monitoring Establish CAR TSCM Cells As A Promising Platform For Next-Generation CAR T Cell Therapies
Women In Life Sciences
Panel Discussion Conference Room 1• Breaking barriers & shaping the future
• Building inclusive working environments
• Fostering the next generation
CMC Considerations For A Smoother Transition Into The Clinic – Lessons Learned From Previous Cases
Industry Presentation Conference Room 1Sponsor 5-minute Flash Talks
Solution Provider Presentation Conference Room 1Title To Be Confirmed.
Industry Presentation Conference Room 1Considerations For Technology Transfer And Scaling Up Manufacturing Into A Regulated Environment
Welcome & Opening Remarks | London Cell Therapy Workshop: Translating the Next Generation of Cell Therapies from Bench to Bedside
Solution Provider PresentationClosing Remarks
Solution Provider PresentationCell Therapy Manufacturing Hackathon
Industry PresentationHackathon Starts: Chair’s Welcome & Challenge Briefing. The session chair introduces the hackathon concept, outlines the central challenge, and explains the expected output from each group.
Cell Therapy Manufacturing Hackathon - Continued
Industry PresentationCell Therapy Manufacturing Hackathon - Group Presentations & Audience Q&A
Industry PresentationFeatured Session: Restoring Hearing With Cell & Gene Therapies: From Bench To Bedside
Panel Discussion Conference Room 3• Understanding the biological landscape
• Patient stratification & indication selection
• Development hurdles • Safety considerations
• Defining and measuring efficacy
Manufacture Of AVB-406, A BBB-Crossing AAV Vector For MAPT Knockdown In Alzheimer's Disease
Industry Presentation Conference Room 5- Aviadobio as a hybrid model development company.
- New products and new challenges require new solutions.
- Case study of AVB-406.
Installing Durable Exhaustion-Resistant Features In CAR T Cells By Hit-And-Run Epigenetic Editing
Industry Presentation Conference Room 5• Non-viral installation of durable gene repression
• A safer alternative to multiplex genome editing
• Long-lasting checkpoint modulation without compromising function
Where Does Big Pharma Stand In CGTs – And What Comes Next?
Panel Discussion Conference Room 5• Big pharma CGT strategy – in-house vs partnerships vs M&A?
• Manufacturing & scale – key bottlenecks in cost, capacity, complexity
• Access & commercialisation – How to overcome pricing, reimbursement, logistics barriers?
• Future innovation – Which next-gen tech (e.g. in vivo editing, non-viral delivery) will lead CGT next wave?
From Discovery To Deliverability: Building The Next Generation Of Cell Therapies
Panel Discussion Conference Room 3• Choosing the right cell platform for the disease
• Overcoming barriers in solid tumours and complex indications
• From models to medicines
Donor Perspectives Of Advanced Therapies Development
Industry Presentation Conference Room 5As cell and gene therapies evolve, so does the donor: from the unrelated donor volunteer to related donor, to the patient as their own donor, to one donor supplying many patients. This talk asks who protects the donor at each step, exploring consent, genetic testing, safety report and future horizons.
Advanced Technologies Driving The Next Wave Of Gene Therapy
Keynote Conference Room 3We view in vivo CAR as potentially representing the next major evolution of engineered cell therapy. While ex vivo CAR-T has demonstrated transformative clinical benefit, in vivo approaches may ultimately broaden access, simplify treatment logistics, and expand applicability beyond the current settings where conventional cell therapies are used. It is exciting that the in vivo approach would democratize Cell Therapy, expansion beyond oncology, and the other platform potentials to be defined.
Overcoming Sterility Testing Challenges In CGT Analytical Development
Roundtable Discussion Conference Room 4• Current regulatory outlook
• Rapid sterility challenges
• Technologies used & research innovations
Mapping Immune Vulnerabilities: CRISPR Screens for Target Discovery
Industry Presentation Conference Room 5Phase Appropriate Analytical Strategies Including Comparability
Industry Presentation Conference Room 4Cracking In Vivo Delivery For Next-Generation Gene Therapies
Panel Discussion Conference Room 5• From ex vivo to in vivo
• Integration of CRISPR, RNA & other systems
• Targeted delivery & available platforms
• Targeting the right cell
Exploring The Future Of Autologous Stem Cell Therapy
Industry Presentation Conference Room 3Emerging Regulatory Guidelines For Individualised Gene Therapies
Industry PresentationFeatured Session: Gene Therapy For Hearing Loss
Industry Presentation Conference Room 3• Genetic testing for hearing loss in the NHS
• Genetic hearing loss- common genes
• Gene therapy for hearing loss, current and future
Changing Regulatory Environment For CGTs In 2027 (SoHO Regulations)
Industry Presentation Conference Room 5This session will explore the key legal and regulatory changes introduced by the EU SoHO Regulation, focusing on their impact on cell and gene therapies (CGTs), regulatory boundaries, authorization pathways, and the practical implications for developers, manufacturers, and healthcare stakeholders ahead of its application in 2027.
Lentiviral Vector As Drug Product – A Gene Therapy Vector Facility Case Study
Industry Presentation Conference Room 5Advances In Manufacturing Of iPSC Derived NK Cells For Immunotherapy
Industry Presentation Conference Room 3• iPSC-derived next-generation immunotherapies provide a scalable, lower cost alternative to allogeneic donor-derived products.
• Plasticell employed its proprietary combinatorial screening technology, CombiCult®, to develop robust, feeder-free, serum-free, GMP-compliant protocols for production of functional Natural Killer (NK) cells from human iPSCs.
• Manufacture of iPSC derived NK cells in agitated culture generated functionally mature NK cells with increased yield, efficiency and purity.
Clinical Trial Designs For Advanced Therapies Outside Of Oncology
Industry Presentation Conference Room 4This presentation explores the evolving landscape of advanced therapy development beyond oncology and into common diseases. It challenges conventional drug-development thinking, introduces clinical and product-development concepts, and outlines a stepwise approach to building confidence. Through clinical study-design examples, it highlights key considerations for developing successful advanced therapy programs.
Programmable Gene Silencing Technology For Next-Generation Advanced Therapy Development
Industry Presentation Conference Room 4Lessons Learned From Cross-Team & Multi-Site Collaboration To Improve Analytical Robustness and Tech Transfer
Industry Presentation Conference Room 4Insights via lived experiences to how cross-team and multi-site partnerships enhanced analytical robustness and accelerated technology transfer. Key lessons focus on communication, governance, method standardisation, and stakeholder alignment to drive consistent analytical performance and successful implementation across organisations.
Efficient CAR-T Research Delivery in the NHS
Industry Presentation Conference Room 5Enablers: CAR-T expertise, comprehensive cancer care, established trials unit, wide referral network, unified healthcare system, high research acceptance.
Barriers: Complex trial design and approvals, separate R&I, NHS and private governance, late UK trial arrival.
Christie example: Journey to top global recruiter in Quintessential 2 trial
Why Regenerative Medicine Stalls And How Europe Can Fix It
Keynote Conference Room 3Regenerative medicine promises curative therapies, yet Europe has struggled to translate scientific excellence into clinical and commercial success. Drawing on a data driven landscaping of European and global RM ecosystems, this talk identifies structural bottlenecks and strategic levers, critical mass, capital deployment, manufacturing, and prioritization, required to engineer a trigger moment and unlock Europe’s regenerative medicine potential.
Featured Session: AI In Decision-Making - EU's AI Perspective
Industry PresentationRegulatory Initiatives For ATMPs In The UK
Keynote Conference Room 4Advanced therapies challenge traditional pharmaceutical regulation systems. The Cell and Gene Therapy Catapult, though CERSI-AT, works with the MHRA, NHS, academia and industry to develop regulatory processes and standards which address implementation barriers and support developers navigating the UK regulatory landscape.
Title To Be Confirmed
Industry Presentation Conference Room 5Featured Session: From Bench To Bedside: Advancing AAV Gene Therapy For Hearing Loss
Industry Presentation Conference Room 3Developing AAV gene therapies for hearing loss requires translating promising science into clinical development while addressing complex technical and manufacturing challenges. This presentation will explore Sensorion’s approach, from therapeutic rationale and preclinical development to clinical translation, highlighting key considerations in advancing innovative gene therapies towards patients.
Biological Reference Materials For The Advanced Therapy Field
Industry Presentation Conference Room 4Precision That Translates: ddPCR from Discovery to Clinic
Solution Provider Presentation Conference Room 3As the biopharmaceutical industry moves towards increasingly data-driven drug development, the ability to generate robust, actionable insights from molecular data is more important than ever. Achieving reliable results across biomarker research, bioanalysis and manufacturing quality control requires sensitive technologies that deliver reproducible data and confidence at every stage. Droplet digital PCR (ddPCR) offers a powerful approach to absolute quantification, complementing multi-omics workflows and helping researchers validate findings, improve data reliability and make informed decisions as programmes progress from early discovery towards clinical application. Through real-world case studies, we will explore how ddPCR can turn complex data into reliable, reproducible insights to support and accelerate clinical development.
Novel Strategies To Enhance CAR T-Cell Function In Solid Tumours
Industry Presentation Conference Room 4This presentation will detail the design and pre-clinical development of a novel armoured CAR designed to target a wide range of solid tumours that is now under clinical evaluation in a Phase I/IIa first-in-human clinical trial.
Developing A Regenerative Macrophage Therapy (RMT) For Fibro-Inflammatory Diseases: Challenges And Opportunities
Industry Presentation• Fibro-inflammatory diseases are complex and hard-to-target with traditional modalities
• Regenerative Macrophage Therapy dual anti-inflammatory and anti-fibrotic mechanism of action is the ideal approach to deliver a disease-modifying therapy in this space
• Resolution shows preclinical and clinical evidence that RMT is well tolerated and has a promising efficacy profile in patients with end-stage liver disease.
vMiX: A Modular AAV-Delivered miRNA Platform For Precise, Durable Gene Silencing Across Indications
Industry PresentationvMiX is a modular platform for AAV-delivered miRNA-mediated gene silencing. Using examples from across our pipeline, this talk describes how a common design and validation framework delivers potent, selective and durable knockdown of distinct targets, and how the platform’s modularity supports rapid application to new genes and indications.
TTMEMs: Modifying Solid-Tumor Cell-Membrane Lipid Composition To Enhance Uptake Of Chemotherapeutic Agents
Industry Presentation Conference Room 3• Dysfunctional tumor cell membranes prohibit chemotherapy uptake
• Timed-Tumor-Micro-Environment-Modifiers (TTMEMs) activate active transporters for chemotherapeutic agents
• Result: Tumor chemo levels increase by 3x. TTMEM response in Sarcoma patients: 94% vs. 38% in control [p=0.0024]. TTMEM approach is highly promising in Target-positive patients (about 50%) across 14 key solid tumor indications
The Development Of The AXIS Trial. Gene Therapy To Halt The Retinal Degeneration In Bardet-Biedl Syndrome
Industry Presentation Conference Room 3• In this presentation we show preclinical data confirming efficacy and safety of the BBS1 gene therapy. It also contains a full biodistribution analysis
• We will describe the dosing strategy for subretinal blebs delivery to maximise results and reduce risk
• We will be presenting the calculations made with different methods to translate the corresponding doses found to be safe and effective in cells and animal models to human doses
Developing A World-First Regenerative Cell Therapy For Hearing Loss
Industry Presentation Conference Room 3The presentation will cover the conceptual framework, development, and preclinical advances supporting upcoming clinical trials of Rincell-1, a pluripotent stem cell-derived otic neuroprogenitor for treating hearing loss
Patient Access In Hospitals To Administer Cell & Gene Therapies
Industry Presentation Conference Room 5Modulatory Action of Stem Cells Secretome in Injury and Degeneration of the Central Nervous System
Industry Presentation Conference Room 3The low regeneration potential of the central nervous system (CNS) represents a challenge for the development of new therapeutic strategies. Mesenchymal stem cells (MSCs) have been proposed as a possible therapeutic tool for CNS disorders, namely due to the beneficial actions of their secretome. Indeed, the latter possesses a broad range of neuroregulatory factors that promote an increase in neurogenesis, inhibition of apoptosis/glial scar, immunomodulation, angiogenesis, neuronal and glial cell survival, as well as relevant neuroprotective actions into different pathophysiological contexts. Considering their protective action in lesioned sites, MSCs, and their secretome, might also improve the integration of local progenitor cells in neuroregeneration processes. In this sense their use could represent an important vehicle for the establishment of future CNS regenerative therapies. Previously we have shown that the administration of MSCs secretome in pre-clinical models of spinal cord injury (SCI) and Parkinson’s Disease (PD) led to important motor and histological improvements. In order to further improve this, in the present talk we will discuss and present the outcomes of the combinatory use of MSCs secretome and biodegrable biomaterials, particularly self-assembling peptides, lypossomes and hydrogels in in vitro and in vivo models of SCI and PD.
Uncovering the Analytical Iceberg: From Early Uncertainty to Commercial Readiness for Cell Therapy
Industry Presentation Conference Room 4• Define phase-appropriate analytical strategy and lifecycle control that starts with the end in mind: patient safety, product quality, commercial readiness.
• Connect product QbD and Analytical QbD by linking control strategy design for the product and scientifically sound data for product understanding.
• Provide practical cell therapy examples to show how to balance the unknowns with analytical rigour while steadily expanding compliance expectations.
The Academic Model Of Advanced Therapies From A Clinician’s Point Of View
Industry Presentation Conference Room 5This presentation explores our academic model for developing advanced therapies from a academic producer’s perspective, highlighting its potential to address unmet medical needs, overcome regulatory and financial barriers, and expand timely patient access. Particular emphasis will be placed on practical challenges, sustainability, and innovative pathways to clinical implementation.
Improving Access To Cell Therapies For More Patient Globally Through The Development Of Novel Off-The-Shelf CIR (™) Technology
Keynote Conference Room 5• Exploring new cell therapy approaches beyond autologous CAR-T, through new targets and new modalities
• Build the next generation of cell therapy that will bring more options to patients, at a fraction of the cost, to improve access to care globally and leverage the multitude of modalities and technologies currently existing
• NKILT's CIR™ technology development to target over 50% of cancer patients across hematologic malignancies and solid tumors
Quality Control Strategies In Advanced CGTs
Panel Discussion Conference Room 4• Which analytical attributes actually predict clinical and manufacturing risk?
• Moving from exploratory assays to release-relevant analytics
• Attributes for quality control
o Standardisation
o Prioritisation
Improving AAV9 Manufacturing Performance With pPLUS® Plasmids And Data-Driven Process Optimisation
Solution Provider Presentation Conference Room 3Recombinant AAV manufacturing is challenged by limited productivity and low full capsid content. This presentation shows how helper plasmid design is a critical lever to improve rAAV yield, F/E ratio and vector quality.
Choice Of Potency Assays For Vascular Cell Therapies
Industry Presentation Conference Room 4- Challenges when testing vasoreparative cell products
- Cell Potency Readouts for endothelial function
Rethinking Fill-Finish For Cell & Gene Therapies: How A Closed Vial Platform Enables Annex 1-Compliant Contamination Control
Solution Provider Presentation Conference Room 4The manufacture of Advanced Therapy Medicinal Products (ATMPs) presents unique contamination control challenges due to the high value of the product, limited batch sizes, and stringent aseptic requirements. Recent revisions to EU GMP Annex 1 have further emphasized the importance of contamination control strategies (CCS) and risk reduction throughout sterile manufacturing processes.
Closed vial processing offers a powerful approach to contamination control, aligned with the principles outlined in EU GMP Annex 1.
Quality by Design: Tailoring QC Strategies for ATMP Development
Keynote Conference Room 4This talk explores how to design stage-appropriate quality control (QC) strategies for ATMPs throughout development, considering the unique challenges of testing complex, variable and often limited-availability products. It will highlight how risk-based approaches, evolving product knowledge and regulatory expectations can guide QC decisions, balancing product quality, patient safety and development efficiency.
SGS Presentation
Solution Provider Presentation Conference Room 4Validating Rapid Mycoplasma Methods for Cell & Gene Therapies: A roadmap to EP 2.6.7 and USP <77> compliance
Solution Provider Presentation Conference Room 4Implementing a rapid mycoplasma method requires a documented validation strategy. This presentation goes through reference strain qualification, method transfer and product-specific matrix validation under EP 2.6.7 and USP <77>.
TROCEPT: A Tumour Targeted Precision Virotherapy Enabling Tumour Localised Expression Of Immunomodulatory Payloads
Industry Presentation Conference Room 3• Cancers are complex and challenging to treat effectively and current immunotherapies have a low response rate in a limited number of patients
• TROCEPT is a precision engineered viral therapy that does not target healthy cells, binds to a solid tumour marker and selectively replicates in cancer cells
• Additionally, the TROCEPT platform enables tumour localized delivery of therapeutic immunomodulatory transgene payloads
FUJIFILM Presentation
Solution Provider Presentation Conference Room 5The French Model Of ATMP Clinical Trials In Rare Diseases
Industry Presentation Conference Room 5CLEIO – French Certified Centres of Expertise in Innovative Therapies.
• Launched in 2025 within F-CRIN (French Clinical Research Infrastructure Network), CLEIO brings together the French Clinical Investigation Centres to strengthen France’s capacity to conduct ATMP clinical trials.
• The network federates existing expertise and infrastructure to improve coordination, responsiveness and attractiveness for academic and industry-sponsored trials.
• Particularly relevant to rare diseases, CLEIO addresses challenges including small patient populations, geographic dispersion and complex trial requirements.
Accelerating Viral Gene Therapy Delivery With AI
Keynote Conference Room 5Gene therapies have amazing potential but are constrained by delivery limitations
AI-powered protein evolution and design can enable far more efficient targeting of viral vectors
Lir is capitalising on this by building a family of virus-focused AI models to completely resurface viral vectors, creating a system that can solve the interlinked problems of viral potency, targeting, and immunogenicity simultaneously
Clinician-Focused Panel Discussion - From Approval To Access: Why Cell & Gene Therapies Still Don’t Reach Patients
Panel Discussion Conference Room 5• The clinician’s reality after approval
• Who carries the risk when outcomes are uncertain?
• Bridging the gap between developers and healthcare systems
• Who provides the education to ensure clinicians want to treat
patients with these options?
Underpinning Advanced Therapy Development Using Microfluidic Approaches
Industry Presentation Conference Room 3Microfluidic technologies offer new opportunities to address challenges in advanced therapy development and manufacturing. This presentation highlights our microfluidic approaches for intensified CAR T cell expansion, real-time process monitoring and improved lentiviral vector analytics, demonstrating how microscale engineering can support more controlled, robust and standardised bioprocessing for advanced therapies.
Beyond Silos: How Cell & Gene Therapies Fit Into The Broader Biotech & Treatment Landscape
Panel Discussion Conference Room 4How do clinicians make modality choices in the real world?
How do CGTs complement — not replace — biologics and small molecules?
What lessons from traditional biotech should CGT learn?
Miltenyi Biotec Presentation
Solution Provider Presentation Conference Room 4Solving the Capacity Crunch: How Do We Scale Advanced Therapy Operations Without Compromising Quality?
Roundtable Discussion Conference Room 5• Managing limited cleanroom and manufacturing capacity
• Optimising scheduling and resource allocation across the vein-to-vein workflow
• Balancing internal manufacturing versus CDMO partnerships
• Future-proofing facilities for commercial demand
Featured Session: AI In Decision-Making - Considerations For The Use Of AI To Support Regulator Decision-Making For Drug And Biological Products
Industry PresentationOvercoming Antigen Heterogeneity In Solid Cancer Using CARKey Technology
Industry Presentation Conference Room 3Beyond Common Serotypes: New Tools For AAV Quantification
Solution Provider Presentation Conference Room 4The rapid adoption of engineered adeno-associated virus (AAV) capsids is reshaping the gene therapy landscape. As vector design continues to evolve beyond traditional serotypes, analytical technologies must keep pace with the growing diversity of AAV variants. Existing methods often require serotype-specific reagents, creating challenges for the characterization of emerging and proprietary capsids.
This presentation introduces two novel complementary analytical assays developed to support AAV detection and quantification across a broad range of naturally occurring and engineered capsids. The assays are based on a common recognition strategy and were designed to provide streamlined workflows while maintaining broad applicability across diverse AAV formats.
Performance data generated with multiple AAV serotypes and engineered capsids will be presented, highlighting key analytical characteristics and demonstrating applicability across a diverse capsid landscape.
These results illustrate how broadly applicable analytical tools can help address the increasing complexity of modern AAV development and support the next generation of gene therapy vectors.
MSC Therapies: From Decades Of Challenges To Commercial Approval
Industry Presentation Conference Room 3Where Advanced Therapies Will Be In 2030: Scientific, Clinical, Regulatory & Economic Futures
Panel Discussion Conference Room 5• From breakthrough to platforms
• Clinical reality vs scientific promise
• Evolving regulatory framework
• Patient access & health system readiness
From Vision And Concepts To Practical Execution - An Analytical Strategy And Lifecycle Execution Roadmap To Support Commercial Readiness And Operational Execution Success
Industry Presentation Conference Room 4• Using an enhanced analytical development program starting with analytical target profiles (ATP) and development staging opportunities to optimize analytical performance.
• Aligning analytical development, manufacturing, and QC controls strategy conditions.
• Pre-/post-commercial capacity expansion and validation considerations for QC operations for autologous cell therapies.
ACROBiosystems Sponsored Workshop
Workshop Conference Room 4Streamlining CAR-T QC: Integrating Label-Free Imaging Into In-Process Flow Cytometry
Solution Provider Presentation Conference Room 7Hindsight is 20/20: Lessons Learned From Developing A Retinal Cell Therapy
Industry Presentation Conference Room 5• Photoreceptor cell therapy has the potential to restore late-stage vision loss in a disease-agnostic manner
• This presentation will share the lessons learned in translating academic research into the clinic for a phase I clinical trial
• How we navigated the challenges of process development, manufacturing and regulatory aspects within the constraints of a research grant
The UK As An Attractive Destination For Cell & Gene Therapy Research
Industry Presentation Conference Room 5The UK has been taking various actions to help ensure that it is an attractive destination for cell and gene therapy research, based on feedback from the pharmaceutical industry. This presentation will highlight actions specifically relating to cell and gene therapy as well as to clinical trials more generally.
Development Of A WHO Approved Phenotypic Flow Standard For Mesenchymal Stromal Cells
Industry Presentation Conference Room 4• The need for improved standardisation in mesenchymal stromal cell (MSC) characterisation, including challenges associated with variability in flow cytometry-based assessment across laboratories and analytical platforms
• Development and characterisation of a candidate MSC reference material, including evaluation of phenotypic marker expression, batch consistency, lyophilisation, and stability
• The potential application of an MSC reference material to support assay comparability and harmonisation, alongside ongoing work towards wider inter-laboratory evaluation
Thought Leadership Panel Discussion: Turning Scientific Breakthroughs Into Sustainable Therapies – Building A Viable Business Model For CGTs
Panel Discussion Conference Room 3• Aligning CMC, regulatory, and hospital strategy to de-risk and accelerate CGT development
• Building scalable, cost-effective manufacturing for long-term sustainability
• New technologies & where the future of CGTs is (e.g. AI, new modalities, in vivo approaches)
Can Early Testing Predict Manufacturing Success At Scale?
Roundtable Discussion Conference Room 3• Production & purification: small-scale vs commercial-scale considerations
• Key process bottlenecks: how can they be identified early?
• Optimisation potential: what can — and can’t — be improved?
Eveo® Cell Therapy Platform: Enabling Scalable And Automated Manufacturing From Hospital To Industry
Solution Provider Presentation Conference Room 3This presentation introduces the Sartorius Eveo® Cell Therapy Platform, a user-owned, closed system for multi-parallel cell therapy production that combines process intensification with smart automation and operator guidance. Collaborator data comparing CAR-T manufacturing in Eveo® bioreactors with established platforms will be presented, along with what these results mean for scalable, cost-efficient production from hospital to industry and for improving patient access.
Translational Development Of A Novel Cardiac Cell Therapy
Industry Presentation Conference Room 3Regenerative Macrophage Therapy (RMT): Targeting chronic inflammation and fibrosis in end-stage liver disease
Industry Presentation• Fibro-inflammatory diseases are complex and hard-to-target with traditional modalities
• Regenerative Macrophage Therapy dual anti-inflammatory and anti-fibrotic mechanism of action is the ideal approach to deliver a disease-modifying therapy in this space
• Resolution shows preclinical and evidence that RMT is well tolerated and has a promising efficacy profile in patients with end-stage liver disease
AI-Powered Cell & Gene Therapy: Accelerating The Next Generation Of Advanced Therapies – The MHRA’s Perspective
Industry Presentation Conference Room 4• AI-driven approaches to cell and gene therapy design, optimisation and development
• MHRA perspectives on AI-enabled advanced therapies, including regulatory considerations and emerging challenges
• Harnessing AI to accelerate manufacturing, clinical translation and regulatory pathways for next-generation CGTs
From DNA Editing And Repair Characterisation To The Definition Of Release Assays In Cell And Gene Therapy
Industry Presentation Conference Room 3• Evolution of Genomic Safety in cell and gene therapy: How insights into DNA repair mechanisms and genome stability transitioned gene editing from exploratory research to structured analytical control.
• Translational Precedents & Regulatory Frameworks: Lessons from clinical benchmarks (e.g., exa-cel, CPS1) on establishing indication-specific risk profiles and meeting FDA/MHRA expectations.
• Defining Rapid Release Assays: Translating high-resolution characterization tools (CAST-seq, NGS) into validated Critical Quality Attributes and phase-appropriate release testing using CLEAR-time dPCR
Towards An iPSC-Derived Reference Material For CAR-T Potency Assessment
Industry Presentation Conference Room 3Will explore challenges in CAR-T potency assessment and the development of an iPSC-derived CAR-T reference material, covering iPSC characterisation, CAR engineering, differentiation towards T cells and potency assay development. The presentation will explore the suitability of this approach for improving the comparability and harmonisation of CAR-T potency measurements.
Gene Editing Safety
Industry Presentation Conference Room 5Great Edit. Now Prove It! — Why Sanger Sequencing and TIDE GxP have their place in approved gene and cell therapies.
Solution Provider Presentation Conference Room 7Hoya Consulting Presentation
Solution Provider Presentation Conference Room 7Astraveus Presentation
Solution Provider Presentation Conference Room 7Verixus Labs Presentation
Solution Provider Presentation Conference Room 7LUMICKS Presentation
Solution Provider Presentation Conference Room 3Managing Analytical Complexity
Roundtable Discussion Conference Room 4• Main analytical challenges
• Streamlining analytics
• Streamlining QC testing for analytics
• Automation & barriers to automation adoption
Session 1 · Developing Novel and Translatable Therapies with Patient Access in Mind
Break Conference Room 1Session 2 · Aligning Manufacturing Workflows With Regulatory Compliance And Commercial Scalability
Break Conference Room 1PartitionBio Presentation
Solution Provider Presentation Conference Room 7Delivering Cell Therapies Into The NHS
Industry Presentation Conference Room 6One Lot, One Life: Scaling Hope for Patients with Autologous CART Treatments
Industry Presentation Conference Room 6As many companies retreat from autologous CART due to its complexity, cost, and scale challenges, patients are left with fewer options despite the life changing potential of these therapies. In this presentation, I’ll showcase the Bristol Myers Squibb journey of navigating the most difficult phase of autologous CAR‑T manufacturing: the critical bridge between commercial launch and the future with fully automated manufacturing. Five years later, we have treated and given hope to over 15,000 patients while achieving business sustainability. I’ll share the key aspects that made this possible.
Robust Manufacturing For Replacement Cell Therapies
Industry Presentation Conference Room 6Designing Large Scale Cell Therapies For Real-World Access
Keynote Conference Room 6- Designing for commercial scalability from the outset: Developing a platform that balances scale, robustness, quality and cost of goods, while maintaining the flexibility required during clinical development.
- Transitioning from clinical to commercial: Lessons from developing Ebstrocel, an allogeneic umbilical cord-derived MSC therapy.
- Building a risk-based commercial strategy: Our experience establishing manufacturing capabilities across clinical and commercial facilities, technology transfer, process development, quality systems and regulatory expectations within accelerated development timelines.
- Connecting strategy to real-world patient access: The importance of supply chain design, process economics and operational flexibility in developing cell therapies that can be delivered reliably and sustainably to patients.
Developing Cutting-Edge Flow-Based Assays For Critical CMC Applications
Industry Presentation Conference Room 6• Flow cytometry is an indispensable tool in early-stage drug discovery and development. However, transitioning this technology from R&D to a (GMP)-compliant QC laboratory setting presents significant challenges.
• Recent advancements in AI, combined with flow cytometry automation technologies offer a scalable path forward.
• This presentation will highlight potential next-gen flow cytometry-based procedures and emerging AI-driven tools which could be utilized in validated environments and are capable of modernizing the QC workflow.
Building For The Future: Phase-Appropriate CMC Strategies
Industry Presentation Conference Room 6From First-in-GMP to 300+ Releases: Building QC into Early Phase ATMP Manufacture
Industry Presentation Conference Room 6CVIC has released over 300 ATMP batches across over 30 clinical trials from an NHS-embedded GMP facility. Early phase manufacturing is a high-mix, low-volume problem, not a scale-down of commercial. This session covers proportionate specifications, control strategies that survive process change that has led to success in EU, US and UK submissions.
Harnessing Digital PCR For Rapid Sterility Testing
Industry Presentation Conference Room 6• Development of a droplet digital PCR (ddPCR) workflow for rapid detection of bacterial and fungal contamination in CAR-T manufacturing samples
• Evaluation of organism coverage, specificity and low-level detection using compendial and manufacturing-relevant microorganisms
• Key scientific and implementation considerations for introducing molecular sterility testing into advanced therapy manufacturing
Designing An End-To-End Supply Chain For CGTs
Industry Presentation Conference Room 6The AI Reality Check: What’s Ready Now, What Isn’t, And How Do We Validate It Safely?
Panel Discussion Conference Room 6• How do regulators expect AI tools to be validated?
• Where are the biggest risks of “black box” AI?
• What are the most immediate, realistic use cases?
Navigating The Regulatory Lifecycle Of Advanced Therapies: CMC, Manufacturing & Comparability Challenges
Panel Discussion Conference Room 6- Platform designation: what prior knowledge realistically transfers between products?
- Specification flexibility at licensure: reducing risk or deferring it?
- Post-approval comparability with donor variability and limited batch numbers
- Generating meaningful post-market evidence
- Managing divergent FDA, EMA and MHRA requirements amid ongoing reform
Outsourcing Biologics’ CMC Development And Manufacturing – Considerations For Supplier Selection
Industry Presentation Conference Room 6• The benefits, risks and mitigations of outsourcing biologics development and manufacturing
• How to best select and manage your CDMO partner - criteria for supplier selection & understanding capabilities and timelines
• The different views of start-ups and big pharma companies
• Good contract making, and how to protect your IP
• Establishing and managing a productive partnership
Bridging Development and Manufacturing Through Predictive Scaling
Keynote Conference Room 6- Design at Scale: Making Cell Therapy Manufacturing Predictable
- Ensuring Cell Quality Throughout Manufacturing
- Developing Best-In-Class Cell Therapy Products
Large-Scale Production Of Human Pluripotent Stem Cell Derived Cardiomyocytes
Solution Provider Presentation Conference Room 6Human pluripotent stem cell (hPSCs)-derived cardiomyocytes (hPSC-CMs) have great potential for regenerative medicine, including preclinical studies in large animal models and tissue engineering. However, robust and economically viable production processes compatible with industry and regulatory standards are required. Given the limited proliferation of hPSC-CMs, pre-expansion of hPSCs to clinically relevant process scales is mandatory prior to their directed cardiomyogenic differentiation.
Here we present a full production pipeline in suspension culture (3D) in stirred tank bioreactors (STBRs), inoculated either with hPSCs derived from adherent (2D) pre-culture (termed: “conventional inoculation”) or directly from cryopreserved “hPSC high-density seeds” (HDS;termed: “direct inoculation”). The process is successively scaled up to 2,000 mL culture scale via a seed train approach. For cell passaging at each upscaling step, EDTA-based dissociation of the suspension culture-induced hPSC aggregates directly in the bioreactor vessel was enabled, while ensuring maintenance of pluripotency and exponential proliferation kinetics.
Finally, cardiomyogenic differentiation in a chemically defined, protein-free medium formulation in 2,000 mL culture scale was performed, yielding >1.3 × 109 cardiomyocytes with typical lineage purity of >90%.
The work demonstrates the robust, scalable production of human cardiomyocytes in clinically relevant quantity and quality while substantially reducing media costs, providing an important step towards GMP-compliant cell production and therapeutic application.
Thermo Fisher Scientific Presentation
Solution Provider Presentation Conference Room 6Scaling IMANs: A Risk-Based CMC Comparability Strategy for Neutrophil Cell Therapy
Industry Presentation Conference Room 6• Building comparability into the CMC strategy from early process development
• Applying a QTPP-led, risk-based approach to scale-up and process change
• Integrating product, process, analytical and stability evidence to support clinical translation
Overcoming Hurdles With Global Commercialisation
Roundtable Discussion Conference Room 6From Academia To Clinical Trials: A Collaborative Journey Between CGT Catapult And Rinri Therapeutics For Successful Development And Delivery Of ATMPs
Industry Presentation Conference Room 6Cell and Gene Therapy Catapult help early developers such as Rinri Therapeutics, accelerate their first-in-kind cell therapy products towards first-in-human trials and beyond. Here we showcase a long-standing collaboration across >13 interconnected projects over 6 years, spearheading the development of Rincell-1, Rinri’s otic neural progenitor cell product.
Advancing HSC Manufacturing Through Automation
Industry Presentation Conference Room 6Automation is advancing HSC gene therapy manufacturing by improving scalability, consistency and patient access. This presentation explores early process integration, platform selection, development, benefits and challenges, and comparability for automation implementation whilst maintaining product quality across the development lifecycle.
Cell Therapy: From Therapeutic Potential To Sustainable Patient Access
Industry Presentation Conference Room 6Assuring Quality At Speed: Enabling Timely Release Of Autologous Cell Therapies
Solution Provider Presentation Conference Room 6Autologous release testing demands speed, precision and rigour. BioReliance's purpose-built capability — rapid methods, strict chain-of-custody and GMP-compliant oversight — ensures patients receive time-critical therapies without delay.
Cell Therapy Manufacturing: Commercialisation, Scale-out and Lifecycle Management
Solution Provider Presentation Conference Room 6Explore the challenges of transitioning cell therapies from clinical to commercial manufacturing, focusing on innovation, scalability, lifecycle management and sustainability to build resilient manufacturing models and expand patient access.
Building Investor Confidence And Translating Science Into Value
Panel Discussion Conference Room 7• What do investors look for in advanced therapies such as cell and gene therapy and regenerative medicine, and across key areas like oncology, rare disease, and autoimmune disease?
• What does it take for biotech companies to become truly investor-ready in this space?
• Where is capital flowing next in advanced therapies, and what is driving those investment decisions?
Morning Break & Refreshments
Close of Day One & Networking Drinks Reception
Lunch Break
Lunch Break
End of Event
Afternoon Break & Refreshments
Morning Break & Refreshments
Afternoon Break & Refreshments
From Cells To Patients: Connecting Innovation, Development & NextGen Technologies In Advanced Therapies To Drive Progress In The Field
Keynote Conference Room 1• From innovation to impact
• Building therapies that progress
• AI-driven innovation
• The next chapter of CGTs & moving forward
Registration, Welcome Lunch & Networking
Session 1 · Developing Novel and Translatable Therapies with Patient Access in Mind
Session 2 · Aligning Manufacturing Workflows With Regulatory Compliance And Commercial Scalability
Networking Break & Refreshments
Networking Break & Refreshments
End of the SONY Workshop
Investing In ATMP Platforms And Enabling Technologies
Panel Discussion Conference Room 7• ATMP manufacturing
• Viral vectors / delivery technologies
• iPSC / stem cell platforms
• Gene editing tools, analytics or enabling technologies
• AI / digital biology
Founders Ask Investors: Open Q&A
Panel Discussion Conference Room 7An interactive, boardroom-style session bringing together biotech founders and investors for an open, practical discussion. Founders will have the opportunity to ask questions directly about fundraising, investor engagement, due diligence, deal structures and building successful investor relationships.
All participating investors are invited to contribute their perspectives, offering practical advice and insights from their investment experience.
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