Cytiva Corporate Session
Wednesday, May 6, 2026
12:00 - 13:00
Liffey Hall 2

Chair

• Peiqing Zhang, Scientific Director - Genomic Medicine, Cytiva, Singapore

 Speakers

• TBA

Session Description

 Cell and gene therapy is in a strategic reset: capital is more selective, with venture capital (VC) investment down ~60% from 2021 and a thin U.S. initial public offering (IPO) window remains thin – yet signal persists beneath the noise. China’s rapid investigator-initiated trials (IIT)‑driven regulatory momentum, State Decree 818, and fast clinical implementation are reshaping global development paths. Hospitals and translational centers are also gaining influence, underscored by the FDA approval of TIGET’s etu‑cel program. As this segment pushs IITs, near‑patient manufacturing, and new evidence models, the balance of capabilities and economics is shifting. On top of all these, a central question now facing the field is whether in vivo CAR‑T can address the infrastructure, clinical, and cost challenges that constrain ex vivo approaches. Our ISCT 2026 panel will explore these shifts and discuss where the next breakthroughs, partnerships, and opportunities are likely to emerge.

 Session Objectives

• How are current market dynamics reshaping the CGT landscape, access, and manufacturing technology path?
• What opportunities and lessons emerge from China’s accelerated development pathways and rapid clinical execution?
• How will the rise of in vivo CAR‑T technologies shape the next phase of CGT development and platform strategy?

Fresenius Kabi Corporate Session
Thursday, May 7, 2026
7:00-8:00
Wicklow Hall 1

Speaker

• Alaina Schlinker, PhD, Director, Global Field Application Support Cell & Gene Therapy Technologies, Fresenius Kabi, USA

Session Description

This session will explore how Fresenius Kabi’s Lovo® and Cue® Cell Processing Systems, which leverage proprietary spinning membrane filtration technology, can streamline critical steps in cell therapy manufacturing. Highlighting our decade of innovation, the session will review expanded applications across both minimally manipulated and gene-modified cell therapies. It will also discuss software enhancements that demonstrate our commitment to supporting regulatory requirements, in particular electronic record standards, supporting compliance with 21 CFR Part 11 and EU Annex 11 through our DXT data management software. The session will conclude with sharing updates on ongoing advancements aimed at enabling rapid CAR-T production, positioning point-of-care manufacturing as a viable option in the next wave of cell therapy manufacturing.

Session Objectives

• Learn how Lovo can streamline cell processing steps, including DMSO removal from thawed cell products, leukapheresis preparation for immunomagnetic selection, and concentration and washing of large volume, culture-expanded cells.
• Understand how our DXT data management software advances electronic record readiness, supporting compliance with 21 CFR Part 11 and EU Annex 11.
• Explore final product freezing preparation with our Cue system, and emerging innovative concepts aimed at enabling rapid CAR-T production and supporting the shift toward point-of-care manufacturing.

SONY Corporate Session
Wednesday, May 6, 2026
12:00-13:00
Wicklow Hall 2A

Chair

• Cheryl Cox, PhD, Operations Director of Cell Therapies & Gene Engineering Facility, Moffitt Cancer Center, United States

Speakers

• Manel Juan MD, PhD, Centro de Díagnóstico Biomédico, University Hospital Barcelona, Spain
• Natalia Maria Marek- Trzonkowska, PhD, Professor, International Centre for Cancer Vaccine Science, University of Gdańsk, Poland
• Barabara Ressler, PhD, Vice President of Manufacturing Process Sciences, RoslinCT, USA
• Kate Fynes, PhD, Senior CMC Translation Consultant, Exmoor Pharma, UK

Session Description:

The advancement of next-generation cell therapies requires robust strategies to enable standardization, scalability, and clinical usage. Leveraging specific T-cell subtypes- particularly through multi-marker-based isolation approaches- offers significant advantages in achieving precise functional cell populations, including naïve regulatory T cells (Tregs), stage- specific Hematopoietic Stem Cells (HSCs) and other emerging cell therapies. 

Advances in rare cell isolation technologies now allow for high-purity enrichment of these critical subsets, supporting improved therapeutic consistency and persistence.  Standardization of cell sorting and processing workflows is essential to minimize variability, ensure reproducibility, and meet regulatory requirements across development stages.

As cell therapies progresses from process development to clinical and commercial manufacturing, scalable and automated solutions for cell selection, expansion, and processing become increasingly vital. 

This session explores enabling technologies and strategies that support high-purity cell sorting, process harmonization, and scale-up, ultimately accelerating the development and delivery of safe, effective, and commercially viable next-generation cell therapies.

Session Objectives

• Discuss the advantages of leveraging specific T-cell subtypes, including multi-marker–based selection strategies, and review available methods for isolating rare cell populations.
• Highlight the importance of standardization and high-purity cell sorting in enabling consistent, safe, and effective cell therapy development.
• Explore scale-up and automation strategies required to transition cell sorting and processing from research to clinical and commercial manufacturing.
• Focus on emerging and next-generation cell therapies, including Tregs, TILs, and other advanced immune cell–based approaches.

Terumo Corporate Session
Thursday, May 7, 2026
12:30-13:30 
Wicklow 2A

Chair

• Maria Knaub, PhD, Global Scientific Engagement Manager, Terumo Blood and Cell Technologies, Germany

Speakers

• Richard Koya, MD, PhD, Professor, University of Chicago School of Medicine, Director of the cGMP Vector Development & Production, University of Chicago Comprehensive Cancer Center, Department of Obstetrics and Gynecology, Biological Sciences Division, United States
• Mindy Miller, PhD, Senior Manager Global Scientific Development, Terumo Blood and Cell Technologies, United States

Session Description:

The commercialization of genetically modified T cell therapies continues to be constrained by two major challenges: slow, labor intensive manufacturing processes and high variability that undermines product consistency. These limitations create bottlenecks that affect schedule adherence, reproducibility, and the ability to scale beyond early clinical programs.

Standardizing and optimizing cell collection is an essential upstream lever to reduce this variability. Harmonized leukapheresis procedures and consistent input specifications stabilize cell quality at the outset, improve predictability of downstream expansion, and create a more reliable foundation for manufacturing planning.

The largest impact, however, comes from innovations within the manufacturing process itself. New data highlight that cultures can be successfully initiated from low starting cell counts, with accelerated expansion enabling earlier achievement of therapeutic dose compared with established manual workflows—all while maintaining high cell quality. Integrated automation further strengthens performance by reducing operator driven variability, lowering contamination risk, and significantly decreasing hands on time. Together, these advances establish a more efficient, reproducible, and commercially viable pathway for producing genetically modified T cell therapies.

 Session Objectives:

• Better starting material = fewer failures later. Optimizing collection ensures high-quality input from sick patients, de-risking the earliest stage of the therapeutic journey to improve downstream reproducibility. 

• Automation replaces fragmented, manual labor to unlock scale. Transitioning to an integrated, automated workflow eliminates operator dependency and significantly reduces variability and Out-of-Spec (OOS) outcomes. 

• Accelerated expansion delivers days back to patients. Reaching the target dose earlier reduces vein-to-vein time and lowers the likelihood of late-stage process deviations caused by time pressure. 

• End-to-end optimization is the foundational infrastructure for commercial success. By connecting collection to therapy, these advancements alleviate bottlenecks, reduce costs, and accelerate patient access. 

Thermo Fisher Scientific Corporate Session
Wednesday, May 6, 2026
7:00-8:00
Wicklow 2A

Chair

• Evan Zynda, PhD, Cell Culture and Cell Therapy R&D, Thermo Fisher Scientific, United States

Speakers

• Saba Ghassemi, PhD, Assistant Professor, Center for Cellular Immunotherapies, University of Pennsylvania, United States
• Evan Zynda, PhD, Cell Culture and Cell Therapy R&D, Thermo Fisher Scientific, United States

Session Description - forthcoming

Thermo Fisher Scientific Corporate Session
Thursday, May 7, 2026
7:00-8:00
Wicklow 2A

 Speakers

• Namritha Ravinder, PhD, Director, R&D, Cell Biology, Life Science Solutions group, Thermo Fisher Scientific, United States
• Young J. Kim, PhD, Scientist III, R&D, Cell Biology, Life Science Solutions group, Thermo Fisher Scientific, United States

Session Description

As engineered cell therapies advance toward commercial-scale manufacturing, there is growing demand for closed, modular, and automated workflows that minimize manual intervention while ensuring product quality, consistency, and scalability.

This presentation will showcase an integrated ecosystem of instruments and GMP-grade reagents designed to enable end-to-end workflow automation—from cell processing and genome engineering through formulation and fill–finish—for both autologous and allogeneic cell therapy manufacturing.

Key Topics:

• End-to-end modular workflow automation, highlighting autologous and allogeneic use cases
• A deep dive into the Gibco™ CTS™ Compleo™ System and its integrated fill–finish capabilities 

Session Objectives

• End-to-end closed, modular automation is achievable today — enabling streamlined cell therapy manufacturing from cell processing through fill–finish within an integrated ecosystem.
• Autologous CAR-T workflow can be standardized and scaled
• Allogeneic workflows (iPSC-to-CAR-iNK) workflow
• The Gibco™ CTS™ Compleo™ System enables controlled, formulation and fill finish.
• An integrated, automated manufacturing framework provides a scalable and reproducible pathway to deliver high-quality next-generation cell therapies while reducing operational complexity.

Waters Corporate Session
Thursday, May 7, 2026
12:30-13:30
Wicklow Hall 1

Speakers

• Lilja Hardardottir, PhD, Senior Scientist, AstraZeneca, UK
• Gianluca Rotta, PhD, Scientific Affairs Manager, Waters Biosciences (formerly BD Biosciences), Italy

Session Description

Breakthrough cell therapies require analytical platforms capable of resolving cellular complexity with greater depth, speed, and precision. While traditional flow cytometry has been a cornerstone technology for decades, advancing cell therapy development now demands multidimensional insights that extend beyond conventional fluorescence based parameters.

This session will highlight how the integration of real time imaging with spectral flow cytometry is expanding the analytical capabilities available to researchers. By uniting real-time imaging with advanced spectral detection, this approach enables more accurate discrimination of rare, heterogeneous, or phenotypically subtle cell subsets. The enhanced resolution and contextual information support more rigorous characterization, streamline experimental workflows, and ultimately facilitate a deeper understanding of cell behavior.

As a leader in next generation cell analysis technologies, Waters Biosciences provides an integrated portfolio designed to support the full cell therapy continuum—from early discovery and process optimization to manufacturing and quality control. Attendees will learn how these advanced analytical capabilities can help reduce development bottlenecks, improve process consistency, and accelerate the path toward delivering high quality, transformative cell therapies with greater clarity and confidence.

For Research Use Only. Not for diagnostic or therapeutic procedures.

Thursday, May 7
10:15  - 10:30
13:00  - 13:15
Forum Global Showcase Theatre A

Presenter

• Kyohei Miyairi, Research Scientist, Research Institute for Bioscience Products & Fine Chemicals, Ajinomoto Co., Inc., Japan

Session Description

The rapid growth of regenerative medicine and cell therapy has increased demand for efficient and scalable expansion of pluripotent stem cells (PSCs). However, many existing media were not designed for large-scale suspension culture, limiting translation into industrial and clinical applications. 

StemFit™ Basic05 was developed to address these challenges, with a focus on scalability, operational flexibility, and clinical compatibility. Formulated entirely with animal-origin–free (AOF) components, it provides a regulatory-aligned foundation for PSC production and delivers robust performance across diverse suspension systems, supporting a smooth transition from laboratory to industrial scale.

Compatible with both suspension and adherent culture, StemFit™ Basic05 enables a single-medium workflow from pre-expansion through scale-up. This reduces variability associated with media switching and simplifies process design and validation, supporting consistent and reproducible PSC manufacturing.

Session Objectives

• StemFit™ Basic05 shows PSC suspension culture performance in various culture system.
• Animal-origin–free formulation supports regulatory alignment and clinical translation.
• Compatibility with both 2D and suspension culture enables a single-medium workflow from pre-expansion to scale-up

Wednesday, May 6
16:30-16:45
Forum Global Showcase Theatre A

Presenter

• Luca Frattini, Production Manager, ANEMOCYTE, Italy

Session Description

Anemocyte is a leading Italian Biotech Manufacturing Organization (BMO) with extensive experience in the field of Cell and Gene Therapies (CGTs) and nucleic acid research, development and manufacturing.

Anemocyte’s core capabilities lie in two specific areas of expertise:

• pDNA (Plasmid DNA);
• mRNA (messenger RNA).

The company leverages over twenty five years of experience to address the continuously evolving needs of the advanced therapies market. A key innovation differentiating Anemocyte is its proprietary, patent pending technology, AMCAP™.

 AMCAP™ is a game-changing one-pot technology for mRNA synthesis that intelligently merges the crucial steps of transcription and capping into a single, seamless reaction resulting in different key advantages such as increase in efficacy and speed, cost-effectiveness, flexibility and scalability.

 AMCAP™ enables the rapid synthesis of high-performance mRNA, positioning Anemocyte at the forefront of the enzymatic capping evolution in mRNA manufacturing.

Session Objectives

•  pDNA and mRNA development and manufacturing solutions
•  Custom and Off the Shelf products
•  Innovative capping technology: AMCAPT
• Analytical services for pDNA and mRNA needs

Wednesday, May 6
16:00-16:15
Forum Global Showcase Theatre A

Presenter

• Thomas Denèfle, PhD, MBA, Director of Product Management & Portfolio Strategy, Astraveus, France

Session Description 

The development and manufacturing of chimeric antigen receptor T cells (CAR-T) using established methods is resource intensive and logistically demanding. This poster will focus on demonstrating that miniaturization and parallelization of end-to-end CAR-T process development and manufacturing via a newly developed microfluidic technology platform offers a solution to these problems. The Lakhesys Benchtop Cell Therapy FactoryTM has been developed and tested to enable parallelized and automated cell therapy processing in an end-to-end fashion, i.e. from cellular starting material to the final drug product, thus covering all critical process steps. The Astraveus team will present latest experimental data to demonstrate the use of this platform in end-to-end CAR-T cells processing, enabling highly efficient cell selection and genetic modification through rapid mass transfer under low shear stress. In addition, the integration of an image-based cytometry module will be discussed. This module enables on-board control of critical process parameters and quality attributes such as cell viability, phenotype and transduction efficiency, thus reducing the need for off-line flow cytometry.

Session Objectives: 

• Introduce Astraveus and the Lakhesys Benchtop Cell FactoryTM to the US cell therapy community
• Demonstrate a novel End-to-End CAR-T process development and manufacturing approach based on microfluidic technology
• Deliver scientific proof points to enable order-of-magnitude improvements in manufacturing cost, patient access and CapEx investment related to cell therapies
• Engage with new partners for user-testing collaborations of the LakhesysTM system

Friday, May 8
10:30-10:45
Forum Global Showcase Theatre A

Presenters

• Raluca Marcu, PhD, Vice President of Scientific Operations, Pluristyx, Inc., United States
• Brian Hawkins, PhD, Chief Technology Office, BioLamina AB, United States

 Session Description

This presentation showcases how Biolaminins support a continuous iPSC workflow spanning research and clinical development to make product cells and tissues. Stage-appropriate Biolaminins enable seamless progression from reprogramming through expansion, cloning, and banking of iPSC while maintaining consistent cell growth and critical quality attributes required for clinical application. This showcase will walk through key stages of iPSC product development, illustrating how choice of and continuity in matrix selection enables smooth transitions between discovery, process development, and product manufacturing without disrupting cell expansion and function while accelerating translation from research to clinical manufacturing.

Session Objectives:

• Understand how Biolaminins enable a seamless iPSC workflow from research to clinical manufacturing.
• Learn how matrix continuity supports consistent growth and critical quality attributes.
• Explore strategies for scalable, GMP-ready iPSC expansion and banking.
• Gain insights into accelerating translation from discovery to clinical application.

Thursday, May 7
15:15-15:30
Forum Global Showcase Theatre A

Session Description

Short life cell and gene therapies (CGT) require fast and reliable release testing. Although, most relevant microorganisms are detected in less than 72h, many manufacturers still apply a 7‑day incubation period for microbial detection for sterility testing.

Through a case study using the BACT/ALERT® 3D DUAL‑T system, an automated growth-based rapid sterility testing solution, we will present how optimized incubation conditions allow 4-day time-to-result, contributing to acceleration of CGT product release, in compliance with regulatory requirements of <USP72> and <EP 5.1.6>.

This path helps CGT developers to safely release short life therapies, improve vein-to-vein time and access to patients.

Friday, May 8
10:15-10:30
Forum Global Showcase Theatre A

Presenter

• Will Gilbert, Cell and Gene Therapy Specialist, Bio-Techne, United Kingdom

Session Description

Cell therapy manufacturing continues to face critical challenges; excessive process complexity, labor‑intensive manual steps, and the operational risks that accompany them. These constraints remain a major barrier to commercial scalability and consistent product quality.  To overcome these bottlenecks, the developers need innovative reagent solutions that simplify workflows, reduce costs, and increase reliability. 

In this presentation, we will highlight how Bio‑Techne is advancing next‑generation reagent technologies to transform cell therapy manufacturing. These include:

·         ProPak™ closed system GMP cytokine delivery which eliminates reconstitution and aliquoting steps to reduce contamination risk and operator hands-on time.

·         AI-engineered heat-stable cytokines which reduce cold-chain logistics and improve cell expansion performance.

·         Ella™ automated ELISA platform which streamlines release testing with rapid, simple, and highly reproducible cytokine assays.

Together, these innovations demonstrate how purpose‑built reagent design can effectively de‑risk manufacturing, strengthen regulatory confidence, and unlock the scalable production needed to bring cell therapies to more patients.

Session Objectives

Cell therapy manufacturing continues to face challenges related to process complexity and significant manual handling. Bio-techne solutions are emerging to help address these barriers in the development and production of cell‑based therapies:

• ProPak™ closed‑system GMP cytokine delivery – Designed to remove the need for reconstitution and aliquoting, helping reduce manual steps and contamination risk.
• AI‑engineered heat‑stable cytokines – Developed to minimize reliance on cold‑chain technologies and to improve cell expansion performance.
• Ella™ automated ELISA platform – Provides a rapid, streamlined approach for conducting cytokine release assays.

Wednesday, May 6
12:45-13:00
Liffey Global Showcase Theatre B

Presenter

• Robert B. Bilsky, Application Scientist, CARR Biosystems, United States

Session Description

As cell and gene therapy (CGT) manufacturing scales from development to GMP, there is increasing demand for cell processing solutions that are gentle, consistent, and easy to implement. This spotlight highlights Single-Use Tubular Bowl Centrifugation as an automated approach for supporting key workflows including iPSC passaging and media exchange, and MSC harvests across scales from 100 ml to 5 L. Compared with traditional manual centrifugation and semi-automated filtration, the system delivered high cell recovery and viability while maintaining expected cell characteristics. MSC harvest achieved viable recovery exceeding 90%, while iPSC workflows demonstrated consistent outcomes with no observable changes in growth or morphology. Automation reduced operator-dependent variability and simplified workflow execution, offering CGT manufacturers a practical and scalable solution for reliable, cell-friendly processing.

Session Objectives

• Gentle, low-shear separation improves outcomes - enabling high cell recovery and viability while protecting sensitive cells.
•  Process parameters enable control - G-force, flow rate, and wash cycles directly influence cell retention and health.
• Consistency supports scale-up - standardized single-use workflows reduce variability and preserve cell quality across scales.

Thursday, May 7
13:30-13:45
Liffey Global Showcase Theatre B

Presenter

• Frederic Cedrone, PhD, Vice President Corporate Innovation, Catalent, United States 

Session Description

In the iPSC‑derived cell therapy space, securing a clinical‑grade iPSC line is a critical milestone—but it is only the beginning. Establishing GMP-ready workflows for reprogramming, gene editing, expansion, differentiation, and analytical assay development, while ensuring consistent quality at scale and readiness for early through late clinical and commercial manufacturing, are all essential steps. None of them are trivial. We approached this journey by starting with the end in mind: iPSCs intended for clinical use and manipulation workflows built for GMP manufacturing. Along the way, we have gained valuable insights from developing lines and processes at scale—lessons we are now applying to help partners accelerate their path from innovation to patient impact. 

 This presentation will highlight key challenges, practical solutions, and how strategic partnerships can streamline access to technologies, starting materials, and scientific and regulatory expertise, ultimately smoothing the path to the clinic and beyond

Session Objectives: 

• Sharing key lessons learned from developing iPSC manipulation workflows, including donor related considerations and the data packages required to satisfy health authorities and regulatory agencies. 
• Demonstrating how coupling GMP iPSC lines with efficient downstream platforms—and leveraging a partnership driven model—can streamline the path from early development to late stage and commercial manufacturing.

Wednesday, May 6
14:45-13:00
Forum Global Showcase Theatre A

Presenter

• Armin Ehninger, PhD, Managing Director and Chief Strategic & Scientific Officer, Cellex Cell Professionals, Germany

Session Description

 Most CDMOs can tell you how to manufacture. Fewer can tell you what breaks when you develop. Cellex can, because we have operated on several sides: as a cell therapy developer, as a CDMO and in cellular starting-material collection. Cell and gene therapies are progressing rapidly, yet many programs still face the same barriers: complex operations, fragile logistics, variable starting material, and manufacturing economics that constrain scalability.

Our path spans apheresis center operation, transport and logistics through hands-on cell therapy development, and the build-out of a full-service commercial stage CDMO platform for autologous and allogeneic products. The core message is simple: we don’t just manufacture; we have made the mistakes ourselves and learned from them. This presentation distills practical lessons from real-world CAR-T manufacturing, focusing on recurring pain points that drive deviations, delays, and cost: incoming material variability, chain-of-identity/chain-of-custody, scheduling and transport constraints, process robustness, analytical readiness, and cross-functional interfaces between sites, couriers, and manufacturing.

We translate these insights into a clear view of manufacturing economics, highlighting key cost drivers and pragmatic countermeasures. Finally, we show how early European manufacturing and logistics set-up, platform standardization, and strategies to improve throughput and supply resilience can de risk cell therapy programs.

Thursday, May 7
13:15-13:45
Forum Global Showcase Theatre A

Presenter

• Masashi Yamada, Manager, S-Quatre Corporation, Japan

Session Description

S-Quatre previously demonstrated the feasibility of scalable, closed-system manufacturing of allogeneic SHED (Stem Cells from human exfoliated deciduous teeth) using the circulation-based, Corning® CellCube® platform.

Building on this foundation, the present study focuses on advanced scale-up strategies and an expanded comparability assessment to support late-phase clinical and commercial manufacturing.

The results demonstrate that the circulation-based closed system maintains critical quality attributes across scale while significantly improving operational efficiency, footprint, and media utilization. These findings provide a practical framework for translating SHED-based MSC manufacturing from clinical to commercial scale and offer regulatory-relevant insights into comparability evaluation for advanced cell therapy products.

Session Objectives: 
•    Exploring an alternative method for scaling cell therapies using a circulation-based process
•    Circulation-based manufacturing process maintains similar cell characteristics to static cell expansion
•    Circulation-based process helps optimize manufacturing costs while enhancing scalability

Wednesday, May 6
12:00-12:30
Forum Global Showcase Theatre A

Session information forthcoming 

Thursday, May 7
15:15-15:45
Liffey Global Showcase Theatre B

Presenter

• Mojtaba Parvizi, DVM, PhD, Global Fast Trak Leader, Cytiva, United States

Session Description

 Ex vivo cell therapy has delivered major scientific and clinical breakthroughs, yet persistent scalability barriers still stand in the way of broader impact. As the field advances toward commercialization, manufacturers continue to face challenges including process variability, labor‑intensive operations, and limited standardization and digital integration. Overcoming these constraints is critical to enabling robust, reproducible, and globally accessible cell therapy manufacturing.

In this session, Cytiva will describe how an integrated manufacturing approach—bringing together instruments, digital solutions, services, and application expertise—can support more reliable and efficient cell therapy production. Emphasis will be placed on end‑to‑end workflow design, process simplification, and connectivity as enablers of consistency, operational readiness, and scalability across evolving therapeutic modalities.

The session will also highlight Cytiva’s collaboration strategy and innovation priorities, illustrating how partnerships and emerging technologies are shaping the next generation of automated, connected manufacturing platforms. Together, these efforts reflect Cytiva’s commitment to advancing sustainable industrialization of ex vivo cell therapy and expanding patient access worldwide.

Session Objectives

• Gain a clear view of today’s ex vivo cell therapy landscape, key manufacturing challenges and the maturity milestones that mark progress.
• Learn how integrated solutions and expertise can help streamline workflows and improve scalability, consistency, and operational readiness.
• Recognize the role of collaborations and innovation in driving automation and advancing the future of industrialized cell therapy production.

Wednesday, May 6
18:45-19:00
Forum Global Showcase Theatre A

Presenter

• Philipp Nold, Business Development Manager CGT Europe, Eppendorf Bioprocess Unit, Germany

Session Description

 The field of cell and gene therapies (CGT) offers great potential to cure hitherto incurable disease. However, it also changes the way we look at the curative agent which, as opposed to traditional therapeutic approaches, is often the cell itself. Therefore, it is more vital than ever to ensure a healthy cell culture by standardized and reproducible culture conditions, minimized contamination risks, and scalability for R&D as well as clinical and commercial manufacturing purposes. As a result, transitioning from R&D to more advanced bioprocess approaches can be complex and comes with its own challenges. Learn in this talk how Eppendorf is addressing these challenges by implementing single-use stirred-tank bioreactor technology, combined with the documentation to support your work in clinical and commercial manufacturing.

Session Objectives

• Learn about successful R&D bioprocess approaches with the potential to make the jump to clinical and commercial manufacturing
• Get to know the challenges that might expect you when attempting the transition from R&D to clinical and commercial manufacturing
• Discover how Eppendorf can support you on your journey

Wednesday, May 6
19:15-19:30
Forum Global Showcase Theatre A

Presenter

• Lindasy Davies, PhD, Chief Scientific Officer, NextCell Pharma AB, Sweden

Session Description

This presentation outlines how partnerships between raw material suppliers and therapeutic developments can address gaps in the CGT portfolio and bring together experience and knowledge to provide solutions to move the field forward. This presentation will discuss the drive behind this partnership and the solutions which these partners are bringing to the market.

Mesenchymal stromal cell (MSC) therapies have shown varied effects in clinical trial, with unparalleled safety profiles, but mixed efficacy. These largely result from differences in cell sources, characterisation and manufacturing methodologies and trial design. In April 2026 the European Pharmacopoeia will release Chapter 5.32 Cell-based Preparations for Human Use. This legislation includes how an MSC should be assayed for purity, identity and functionality.

NextCell Pharma, a late-stage clinical MSC development company working with umbilical cord (UC) derived MSCs for the treatment of autoimmune and inflammatory disorders have partnered with FUJIFILM Biosciences,  is a global, full spectrum supplier to the life sciences market, including GMP compliant MSC cell culture media and DMSO-free cryopreservants to generate a Research Use Only UC-MSC product to support academics and developers who need a well characterised MSC product to establish new MSC products and perform mechanistic studies. Importantly these cells have been established as a reference material for QC assays and is the first in a portfolio of products to provide developers with cells from research through to GMP starting material for their own drug products.

Session Objectives

• Explain the products generated by NextCell Pharma and Fujifilm Biosciences to address gaps in the MSC market.
• Demonstrate the need for standardised cell products and associated raw materials for the development of MSC cell therapies.
• Evaluate how these new products will support success cell therapy development with changing legislation within Europe.

Thursday, May 7
10:30-10:45
Liffey Global Showcase Theatre B

Presenter

• Alejandra Gutierrez Guerrero, Product Manager, Grifols, Spain

Session Description

 This showcase will explore how the selection of human raw materials—and the choice of a qualified supplier—can materially influence cell‑therapy robustness, regulatory readiness, and scalability. As human‑derived materials are central to both cell sourcing and cell expansion, particularly for T‑cell-based therapies, ensuring consistent quality, traceability, and supply continuity is critical to reducing clinical and manufacturing risk.

Grifols, a leading global healthcare company manufacturing plasma-derived medicines, through its Bio Supplies division, supports cell-therapy programs with high-quality human biological materials, including fresh and cryopreserved leukopaks, GMP human male AB serum, and EP/USP-grade human serum albumin (HSA), all produced and managed under high‑level quality systems. Materials are sourced through a global network of FDA‑ and EMA‑compliant donation centers in the U.S. and continental Europe, with strong control over donor selection, characterization, and traceability.

By combining human‑relevant materials with rigorous quality oversight, regulatory documentation, and reliable supply, Grifols enables developers to integrate compliant human raw materials

Session Objectives

• Understand how human raw material selection impacts cell‑therapy consistency, performance, and regulatory readiness.
• Learn how donor control, traceability, and quality systems reduce manufacturing and compliance risk.
• Explore how fresh and cryopreserved leukopaks collected from Europe support global clinical development and logistics.
• Recognize the role of human supplements (GMP male AB serum and EP/USP-grade HSA) in supporting xeno‑free, T‑cell expansion strategies.
• Appreciate the value of early alignment with a compliant, reliable supplier to enable scalable cell‑therapy manufacturing.

Friday, May 8
12:15-12:30
Liffey Global Showcase Theatre B

Presenter

• Saori Yamanaka, General Manager, Bio and Pharmaceuticals Business Development, Hitachi, Ltd., Japan

Session Description

Cell and gene therapy manufacturers increasingly face challenges in achieving consistent quality and predictable performance across highly variable biological processes. Hitachi is addressing these industry needs through an integrated set of capabilities spanning measurement, QC, cell‑level simulation, and smart manufacturing automation —a framework that also encompasses solutions such as iACE® and iACE mini platforms for automated cell-culturing and digital platforms such as HITPHAMS® (MES) and HVCT RM® (value-chain tracking system)  that support production management and value‑chain data integrity.

 These combined capabilities enable a clearer understanding of culture behavior and more informed process development, resulting in higher confidence in product quality—while providing a practical, scalable pathway toward digital‑ready and automation‑supported manufacturing.

 In 2026, Hitachi aims to deepen collaboration with global innovators by exploring multiple joint opportunities to validate these approaches in real manufacturing environments. Rather than presenting fixed programs, Hitachi is actively seeking partners—such as CDMOs, technology developers, and therapeutic companies—interested in co‑creating feasibility studies that leverage sensing, QC, simulation, and digital/automation platforms to enhance process robustness.

 This session outlines Hitachi’s strategic direction and invites collaboration with organizations committed to advancing scalable and reliable CGT manufacturing.

Session Objectives:

• Provide an overview of Hitachi’s key technology pillars for next‑generation CGT manufacturing: Measurement/QC, cell simulation, smart automation, and digital platform.
• Highlight how digital cell‑level simulation contributes to predictive, data‑informed process development and improved manufacturability.
• Share Hitachi’s intention to collaborate with CDMOs and technology partners to explore feasibility studies and early proof‑of‑concept (PoC) opportunities.
• Introduce the role of iACE, HITPHAMS, and HVCT RM in building a quality‑driven digital manufacturing backbone
• Present areas where Hitachi seeks mutual collaboration to drive more predictive, stable, and scalable manufacturing of advanced therapies.

Friday, May 8
12:15-12:45
Forum Global Showcase Theatre A

Presenter

• Kate Broderick, PhD, Chief Scientific Innovation Officer, Artis BioSolutions, United States

Session Description 

Cell and gene therapy development has a starting material problem. For all the advances in vector design, process development, and GMP infrastructure, the field has remained structurally dependent on plasmid DNA, with all the quality variability, supply risk, and manufacturing constraints that come with it. A new approach is emerging: de novo synthesized DNA that bypasses the plasmid entirely, enabling higher purity, tighter sequence control, and a fundamentally cleaner path to GMP-grade production of mRNA and other genetic medicines.

This session will make the case that synthetic DNA isn't just an incremental improvement — it redefines what a truly integrated development and manufacturing platform can look like. Dr. Broderick will draw on the distinct capabilities within the Artis BioSolutions ecosystem: Syngoi Technologies' proprietary capacity to produce optimized synthetic DNA and carry it all the way through to GMP supply, and Landmark Bio's CDMO platform, where deep in-house expertise in complex cell systems, emerging modalities, and flexible program structures — supported by a rare convergence of industry, academic, and clinical partnerships — creates a development environment built for the complexity of next-generation genetic medicines.

Session Objectives

• Understand why the move from plasmid to de novo synthetic DNA represents a structural shift in CGT manufacturing—not just a supply chain upgrade
• Explore how Landmark Bio's integrated model—spanning complex cell systems, emerging modalities, and uniquely cross-sector partnerships—addresses the flexibility gaps that standard CDMOs can't fill
• Learn how Syngoi's end-to-end synthetic DNA platform eliminates dependencies that have historically constrained mRNA and gene therapy programs
• Gain perspective on what full vertical integration, from synthetic DNA to GMP manufacturing, means practically for development timelines, risk, and program decision-making

Thursday, May 7
12:15-12:45
Forum Global Showcase Theatre A

Session Description

Lonza has expanded its TheraPEAK® Platform with the launch of TheraPEAK ActiCell™ Activation Reagent, completing a serum‑free solution for robust T‑cell growth. Together with TheraPEAK® T‑VIVO® Cell Culture Medium and the TheraPEAK AmpliCell® Cytokines, ActiCell™ T-cell Activation Reagent enables a unified workflow that supports consistent activation, sustained expansion, improved viability, and preservation of key lineage and memory markers. The integrated TheraPEAK T‑VIVO®/AmpliCell®/ActiCell™ System demonstrates strong compatibility with viral transduction workflows, resulting in significantly higher transgene-positive cell populations under optimized conditions. This newly completed platform provides researchers with a reliable path to producing high‑quality T cells in a serum-free environment for advanced cell and gene therapy applications.

Session Objectives: 

• Recognize the advantages of a fully serum‑free, unified T‑cell workflow
• Understand how the TheraPEAK® T‑cell culture platform can support a serum free process
• Evaluate the impact of the integrated TheraPEAK T‑VIVO®/AmpliCell®/ActiCell™ System on workflow performance

Thursday, May 7
12:15-12:30
Liffey Global Showcase Theatre B

Presenter

• Karin Abitorabi, Head of Process and Analytical Development & Innovation, Minaris Advanced Therapies, Germany

Session Description

The development of cell and gene therapy (CGT) products requires strategic decision-making across multiple stages of development. In this presentation, we address key considerations, starting with the selection of the appropriate starting material and the choice of material suitable for pre-clinical toxicology studies. We place particular emphasis on generating reliable data that are fit for regulatory submissions and that support further development.

We further examine how large-scale process recoveries determine the number of cells required and influence overall dose manufacturing. We outline key aspects of GMP set-up, including equipment footprint and material quality. In addition, we highlight common pitfalls in process and analytical development. Finally, we address the importance of maintaining a robust chain of custody and sharing practical, real-world lessons learned throughout CGT development.

Session Objectives:

• Understand how to select the appropriate starting material
• Identify suitable material for pre-clinical toxicology studies
• Recognize the importance of batch quality
• Understand how large-scale recoveries determine the number of cells required
• Identify key considerations for GMP set-up, including footprint and material quality
• Recognize common pitfalls in process and analytical development
• Understand the importance of maintaining chain of custody
• Learn from real-world lessons in CGT development

Wednesday, May 6
12:15-12:30
Liffey Global Showcase Theatre B

Presenter

• Ashley Shih, MSc, Application Specialist, Cell and Gene Therapy, PHC Europe, Netherlands

Session Description

Cell energy utilization—such as glucose consumption and lactate production—offers critical insight into fundamental cellular processes in the cell and gene therapy field, including stem cell differentiation, immune activation, and tumor growth. Monitoring these metabolic parameters provides a direct and powerful window into cellular function.

Continuous, real-time measurement delivers dynamic, high-resolution data, enabling a more accurate and comprehensive understanding of metabolic profiles and cell state over time.

In this talk, we introduce the Live Cell Metabolic Analyzer (LiCellMo), powered by PHC’s proprietary in-line sensor technology, and demonstrate how it enables real-time, long-term glucose and lactate monitoring to support precise cell condition tracking and culture optimization.

Session Objectives

• Cell energy utilization is a key indicator reflecting cell state and process performance in CGT manufacturing
• Enable confident process decisions:
  Automated, continuous measurements of metabolic parameters ensure objective, consistent data, delivering reliable, reproducible cellular insight 
• Improves cost and operational efficiency: Automated measurement eliminates manual sampling, reduces contamination risk and protects high-value CGT products

Thursday, May 7
10:30-10:45
Theatre A, Forum Floor (Ground Level)

Presenters

• Anida Mesihovic Karamitsos, PhD, QIAGEN, Germany
• Arvind M Padma, PhD, CCRM Nordic, Sweden 

Session Description

Precise and standardized analytical control is essential for robust cell and gene therapy development. Digital PCR (dPCR) has emerged as a preferred method for high sensitivity and absolute quantification required for critical quality attributes (CQAs) such as viral vector genomes, residual host-cell DNA, mycoplasma contamination and other safety and identity markers. This presentation will introduce the QIAcuity Digital PCR Platform and summarize ready to use workflows that enable fast, integrated QC of cell and gene therapies. The first half of the talk will outline key principles of dPCR, highlight platform-specific advantages of QIAcuity for regulated environments, and demonstrate how standardized assays streamline analytical development and lot release testing.

 The second half of the talk will focus on practical implementation of vector copy number (VCN) and replication competent lentivirus (RCL) analysis in CAR T manufacturing samples. We will discuss assay considerations such as target selection, thresholding strategies and the role of restriction digestion. Comparative data from three CAR T manufacturing approaches will illustrate how harmonized dPCR workflows improve reproducibility and interpretability across platforms, supporting safe and scalable process development.

Session Objectives

• Introduce dPCR principles and QIAcuity platform advantages, including ready to use QC solutions for viral vectors, residual DNA and mycoplasma testing
• Present practical frameworks for VCN and RCL assays, covering target selection, use of restriction digestion and strategies for assay standardization
• Compare VCN/RCL results from three CAR T manufacturing approaches and discuss reproducibility, operational considerations and data interpretation

Wednesday, May 6
12:30-12:45
Forum Global Showcase Theatre A

Presenter

• Prasad Kakarla, PhD, Global Product Manager, Sartorius Stedim Biotech GmbH, Germany

Session Description

 This work describes a closed, automated downstream workflow for iPSC aggregate concentration, washing, controlled dissociation, and re-expansion using continuous counterflow centrifugation. The process minimizes shear stress and manual intervention while delivering high cell recovery, viability, and functional integrity. iPSCs processed through this workflow were successfully differentiated into cardiomyocytes, demonstrating preserved cell potency and suitability for grafting applications. By enabling aggregate-to-single-cell processing within a single, aseptic cycle, the approach reduces process variability and supports scalable, GMP-compliant iPSC manufacturing and seed train-like process intensification.

Session Objectives

• Discover a fully integrated, automated iPSC downstream platform that consolidates concentration, washing, dissociation, and re-expansion into a single, closed, aseptic workflow
• See how low-shear processing preserves cell recovery, viability, and differentiation potency from aggregates to functional cells
• Understand how a GMP-ready, scalable solution reduces variability and accelerates industrial iPSC manufacturing

Wednesday, May 6
19:00-19:15
Forum Global Showcase Theatre A

Presenter:

• Nooshin Tabatabaei-Zavareh, PhD, Associate Director, RND, Immunology, Culture & Applications, STEMCELL Technologies, Canada

Session Description

As cell and gene therapies advance toward broader clinical and commercial application, the need for robust, scalable, and GMP-manufactured ancillary materials is more critical than ever. This showcase will highlight next-generation solutions designed to support the seamless translation of hematopoietic and immune cell therapies from early development to clinical manufacturing.

We will explore emerging strategies for the expansion and differentiation of immune cells from both primary and stem cell-derived hematopoietic progenitors. These approaches leverage serum-free, GMP-manufactured media with the addition of differentiation supplements to enable reproducible HSPC expansion and controlled lineage commitment, while maintaining flexibility across diverse manufacturing platforms and downstream differentiation systems.

Together, these examples will illustrate how rigorously designed ancillary materials can simplify scale-up, improve reproducibility, and support the consistent generation of high-quality hematopoietic and immune cell therapy products.

Thursday, May 7
12:45-13:00
Forum Global Showcase Theatre A

Presenter

• Scott Tasker, Instrument Field Applications Specialist, STEMCELL Technologies, Canada

Session Description

 Cell sorting is a critical step in many cell therapy workflows, enabling the purification of defined cell populations for downstream processing. However, conventional droplet-based sorting methods often present challenges in clinical environments due to aerosol generation and the associated risk of sample cross-contamination.

 Here, we present Highway1™, a microfluidic, cartridge-based cell sorter that enables rapid and user-friendly purification of cells under closed, sterile conditions. In this showcase, we demonstrate how Highway1™ microfluidic cartridges, powered by VACS™ (Vortex Actuated Cell Sorting) technology, deliver low-shear, gentle sorting to preserve cell viability and functional integrity, resulting in high-quality purified populations. suitable for wide varieties of downstream applications.

 Finally, we highlight how the Highway1™ platform supports affordable, high-quality cell isolation across the full translational pipeline. By utilizing interchangeable cartridge variants manufactured under an ISO 13485-certified quality system, Highway1™ provides process-appropriate closure and regulatory compliance, allowing researchers to scale from early development to clinical manufacturing on a single instrument.

Wednesday, May 6
16:15-16:30
Forum Global Showcase Theatre A

Friday, May 8
10:30-10:45
Liffey Global Showcase Theatre B

Presenter

• Glenda Joanne Dickson, PhD, Senior Principal Scientist – Innovation, ViroCell Holdings, UK

Session Description

The in vivo generation of stable genetically modified cells has great therapeutic potential for a variety of applications, such as treatment of the inherited and genetic disorders ranging from cancer to cardiovascular disease.  Effective in vivo therapies require efficient targeting of specific cell subsets, the efficiency of which will depend on multiple parameters such as the homing of the gene delivery to the desired cell subtypes, coupled with efficient, regulated and/or tissue specific transcription and translation of the therapeutic gene/s.  A number of lentiviral characteristics make these particularly suitable for such clinical applications, particularly when the payload is large, complex regulation is needed and/or stable modification of dividing cells are required.

 The clinical application of gene therapy requires consideration of safety parameters, including adequate de-targeting of the off-target cells and the engagement of intuitive, on target and context dependent expression of complex vector payloads.  Such vectors can now carry combinations of multiple constitutive cassettes as well as intuitive and context dependent expression of efficacy modulators, and/or auto-responsive safety switches.

Session Objectives

• Discuss essential features for in vivo LVV delivery – advantages of LVV : AAV : RVV
• Illustrate T/NK/NKT cell targeting with CD7 and CD3
• Describe T cell specific promoters and context appropriate regulation of expression
• Outline liganded vectors possessing stimulatory/protective signals

Thursday, May 7
12:30-12:45
Liffey Global Showcase Theatre B

 Presenter

• Robert C. McCarthy, PhD, President, VitaCyte LLC, United States

Session Description

Smart manufacturing involves bringing together developers, equipment providers, and suppliers to break down silos, reduce development time, and create efficiencies that align products and solutions with customer needs. Leading companies have pioneered such system-based thinking across a variety of industries, including automobiles (Toyota), technology (Nvidia), and biotechnology (Eli Lilly & Co). Lilly has been at the forefront of this shift, leveraging open innovation models to identify new drug candidates, scout teams to pursue new opportunities, and establish outsourcing partnerships to strategically support its business. 

VitaCyte’s vision is to develop and manufacture the highest quality Clostridium histolyticum collagenases and associated proteases used for recovering cells from tissue or after in vitro culture. In 2026, the company launched VitaCyte Solutions – an application and development lab – to bring together VitaCyte’s subject matter experts and scientists from instrument providers to create new enzyme-mediated cell recovery solutions for different applications. Colocation of development activities and convening experts enables systems thinking and knowledge sharing to optimize new products and services.

The specific details of VitaCyte Solutions will be shared during the presentation.

Session Objectives

• Share VitaCyte’s capabilities to manufacture purified, customized collagenase or protease enzyme mixtures with other firms who may be interested in establishing collaborative projects
• Colocalization of experts with complementary skills leads to development of targeted products in a shorter time and a lower cost than traditional R&D
• Co-localization of experts focused on a defined problem is the most efficient method for product development (e.g., Lockheed skunkworks)