ATMP 2030: Future-Proofing Advanced Therapy Manufacturing
Wednesday March 11 2026, Corpus Leiden
Shape the Future of ATMP Manufacturing: Join the Dutch ATMP Summit 2026
Get ready to explore the next era of advanced therapy production at the Dutch ATMP Summit 2026! This year’s theme, “ATMP 2030: Future-Proofing Advanced Therapy Manufacturing,” puts CMC, GMP, and real-world manufacturing challenges at the heart of the program.
As the ATMP field accelerates, the demand for safe, consistent, and scalable production is greater than ever. Industry leaders will reveal what must change in manufacturing, analytics, digitalization, and regulatory frameworks to ensure next-generation therapies can reach patients efficiently and reliably.
Join top experts from CBG-MED (regulators), Fuse Vectors, LUMC, Ntrans Technologies, Solvias, Zelluna, Progress – Experts in Life Sciences and others as they deliver high-impact insights across four pillars: production innovation, advanced analytics & QC, translational development, and regulatory future outlook. You’ll dive into real-world case studies, emerging technologies, and future-shaping strategies that will define the ATMP landscape toward 2030.
With dynamic Q&A sessions and exceptional networking opportunities, this is your chance to connect with key players, exchange ideas, and prepare your organization for the next generation of ATMP manufacturing.
Don’t miss out. Be part of the ATMP 2030 movement at the Dutch ATMP Summit on Wednesday March 11 2026!
Full day program
09:00 – 09:30 Registration + coffee
Start the day with coffee during registration.
09:30 – 09:45 Welcome & Opening Remarks
Chair of the day: Cor Marsman – Progress, Experts in Life Sciences
Short welcome by Edwin to introduce the theme:
“From scientific discovery to GMP – preparing ATMP manufacturing for 2030.”
09:45 – 10:30 Presentation
- Thilo Buck – Progress – Experts in Life Sciences:
“Towards ATMP 2030: Building Continuous Validation Frameworks on Strong CQA Foundations.”
Explores how AI, synthetic platforms, and automation reshape validation philosophy in ATMPs, drawing from new ISPE guides and the RSNN Gene Editing initiative.
10:30 – 11:15 Presentation
- Namir Hassan – Zelluna ASA:
“Off-the-shelf T Cell Receptor-based Natural Killer cells for the treatment of solid cancer.”
11:15 – 11:45 Coffee Break & Networking
Enjoy some coffee and refreshments before the next presentation.
11:45 – 12:30 Joint Presentation
- Prof. Niels Geijsen – LUMC:
Dr. Ester Weijers – NTrans Technologies
“Next-Gen Gene Editing for ATMPs: Academic Insights and Industrial Innovations.”
A joint session linking CRISPR/Cas science in regenerative medicine with non-viral delivery innovation.
12:30 – 13:30 Lunch + Poster session
Lunch available.
Poster session in the foyer.
13:30 – 13:45 Energizer
Led by Cor Marsman.
13:45 – 14:30 Presentation
- Benjamin Blaha – Fuse Vector:
“Reinventing AAV Manufacturing: Synthetic Biology Meets ATMP Scalability.”
How in vitro AAV synthesis could overcome vector bottlenecks and reshape regulatory and QC approaches.
14:30 – 15:15 Presentation
- Erik Splinter – Solvias:
“The use of NGS for characterization and viral safety.”
Advanced sequencing strategies to define and monitor critical quality attributes (CQAs) in ATMPs.
15:15 – 15:45 Coffee Break
Take a short break before the final sessions of the day.
15:45 – 16:30 Presentation
- Marcel Hoefnagel – CBG-MEB
Presentation to be announced.
16:30 – 17:00 Panel Discussion
Panel featuring speakers from regulators (CBG-MED), Fuse Vector, NTrans Technologies, IGJ, and Progress:
“Translating Innovation to GMP.”
Topic: “What must change today to manufacture ATMPs successfully in 2030?”
17:00 – 18:00 Networking & Drinks
Enjoy drinks and networking opportunities.
Speakers
Benjamin Blaha, Ph.D
Co-CEO, CTO, and Co-Founder
Fuse Vectors
Benjamin Blaha, PhD, is Co-CEO, CTO, and Co-Founder of Fuse Vectors, where he leads the development of a next-generation, fully cell-free AAV manufacturing platform. With deep expertise in vector engineering and early-stage CMC strategy, he focuses on redesigning viral vector production to overcome the intrinsic limitations of cell-based systems. Before founding Fuse Vectors, Benjamin held senior roles in gene therapy process development — including leading early CMC programs and cross-functional teams at uniQure — and provided specialized consulting on experimental design and manufacturing innovation at NecstGen. His work centers on building faster, more consistent, and more scalable vector manufacturing technologies. At Fuse Vectors, he drives the integration of enzymatic assembly, high-throughput recipe screening, and seamless scale-up toward future GMP readiness.
Erik Splinter, Ph.D
General Manager
Solvias Netherlands
Erik Splinter, PhD, is General Manager at Solvias Netherlands and formerly Chief Technology Officer at Cergentis, where he led the development and industrialization of Targeted Locus Amplification (TLA) for complex genomic analysis. With a background at Erasmus MC and the Hubrecht Institute, Erik has deep expertise in 3D genome structure, chromatin biology, and high-resolution sequencing technologies. His work focuses on developing robust genetic QC solutions that support the safe manufacturing of advanced therapies, including lentiviral vector integration mapping, gene editing outcome analysis, and engineered cell line characterization. At Solvias, he oversees teams providing advanced analytics and CMC-critical testing to global biotech and ATMP developers. His research has been published in Nature Genetics, Genes & Development, and Molecular Cell
Prof. Niels Geijsen
Head of Department, Anatomy & Embryology
Leiden University Medical Center (LUMC)
Prof. Niels Geijsen is Professor of Developmental Biology and Regenerative Medicine and Head of the Department of Anatomy and Embryology at Leiden University Medical Center (LUMC). His research focuses on developing innovative technologies to understand and manipulate human skeletal muscle development, homeostasis, and regeneration, with a particular emphasis on genetic muscle disorders such as Duchenne Muscular Dystrophy (DMD) and Facioscapulohumeral dystrophy (FSHD). His group has developed new delivery strategies for introducing gene-editing systems into target cells and demonstrated the efficient delivery of recombinant CRISPR/Cas ribonucleoprotein complexes across a broad range of cell types. Building on this expertise, his team continues to design next-generation genome engineering approaches aimed at precise and efficient correction of disease-causing mutations both in vitro and in vivo. In addition to his academic leadership, Dr. Geijsen is co-founder of NTrans Technologies, a biotechnology company developing next-generation imunno-oncology solutions, and co-founder of Divvly, an IT company creating digital tools for life science research.
Ester Weijers, Ph.D
Chief Executive Officer
NTrans Technologies
Ester Weijers, PhD is Chief Executive Officer of NTrans Technologies, a Leiden-based biotech company pioneering intracellular delivery platforms for next-generation cell and gene therapies. With a scientific background in regenerative medicine and vascular biology (PhD, Vrije Universiteit Amsterdam), Ester combines a deep understanding of complex biology with a passion for translating innovation into real-world therapeutic impact. Before joining NTrans, she worked as a Managing Consultant at Catalyze, advising biotech ventures on funding and strategy. At NTrans, she leads a multidisciplinary team advancing GMP-ready delivery systems for CRISPR/Cas applications in immuno-oncology and hematology. Driven by purpose and collaboration, Ester champions a culture where science, strategy, and creativity converge to bring breakthrough therapies to patients
Thilo Buck, Ph.D
Senior Consultant
Progress – Experts in Life Sciences
Thilo Buck is Senior Consultant specialized in CMC strategy, validation, and ATMP manufacturing. He serves as Co-Chair of the ISPE Netherlands Pharma 4.0 Community, contributing to guidance on Validation 4.0 and data-driven quality systems. Thilo co-led the RSNN expert workshop on in vivo gene editing, authoring the quality criteria section. He supports developers in designing QbD-based control strategies, CQA frameworks, and continuous validation approaches for advanced therapies. With a background in viral-vector gene therapy, he bridges scientific insight with practical GMP and digital innovation.
Namir Hassan
CEO
Zelluna Immunotherapy
Namir Hassan is the CEO of Zelluna Immunotherapy and a seasoned leader in immuno-oncology with over 20 years of experience developing first-in-class therapies. He was an early developer of KIMMTRAK, the first approved TCR-based therapy, and has led programs spanning discovery, manufacturing, and early clinical development. At Zelluna, he drives the advancement of the company’s pioneering allogeneic TCR-NK platform, guiding ZI-MA4-1 toward first-in-human trials in 2026. Namir also serves as a visiting lecturer at the University of Oxford and is recognized for his strategic leadership in translational medicine and next-generation cell therapy innovation.
Marcel Hoefnagel, Ph.D
Senior Assessor Biopharmaceuticals
CBG-MEB
Dr. Hoefnagel is a Senior Assessor of Biopharmaceuticals at the Medicines Evaluation Board (MEB), with specialized expertise in advanced therapy medicinal products (ATMPs), vaccines, allergens, biosimilars, and immunogenicity assays.
Since 2012, he has been actively involved in the regulation of cell and gene therapy products (CGTPs), contributing to the development of guidance documents for both CGTPs and ATMPs. He co-organized the EMA/FDA initiative supporting quality development in early access approaches, which led to the creation of the Toolbox guidance. This framework was designed to strengthen quality data packages for products addressing unmet medical needs and played a key role in accelerating the development and assessment of COVID-19 vaccines.
Dr. Hoefnagel has published extensively on potency testing for cell-based products. His current research focuses on the regulatory impact on the quality and cost of CGTPs, as well as on the development of in vitro assays to replace in vivo potency testing for vaccines, as part of the IMI project VAC2VAC.
As Chairman of the Substance Validation Group, he is also involved in the development of an international Substance Registration System in collaboration with the EMA and FDA (EU-SRS and G-SRS).
Access to the Dutch AMTP Summit at March 11 2026.
Dutch ATMP Summit 2026
With this ticket you will get access the the Dutch ATMP Summit on Wednesday, March 11, 2026 in, Corpus Leiden. You can join all the talks of our speakers and meet your colleagues in the field during networking drinks. During the day there are refreshments.
Second ticket for half of the price.
Share Your Work at the Dutch ATMP Summit 2026
Are you working on an exciting project in ATMP manufacturing, analytics, or regulatory science?
This year, the Dutch ATMP Summit introduces a Poster Session to showcase innovative ideas, case studies, and scientific insights from across the field.
We invite researchers, startups, and industry professionals to submit a poster abstract related to one of the following themes:
- Manufacturing & Process Innovation – e.g. scale-up, cleanroom design, automation, digital twins
- Analytics & Quality Control – e.g. in-process control, AI-based QC, comparability, CQA/QTPP
- Regulatory & Translational Science – e.g. GMP compliance, regulatory frameworks, risk management
Participants are invited to submit scientific or case-based posters in A0 size, vertical orientation. If ten or fewer posters are selected, all will be presented during the lunch session (12:00–13:00), each accompanied by a brief 5-minute pitch by the presenting author. If more than ten posters are accepted, they will be scheduled across lunch and coffee breaks and grouped by theme. Interested participants can indicate their intention to present a poster during registration or by submitting an abstract using the Poster Submission Form. Abstracts must not exceed 250 words and should include a title, author names, affiliations, and contact information. Please also indicate the relevant theme.
Why Participate?
The poster session offers an informal, interactive platform to:
- Share new data, methods, or lessons learned
- Connect with ATMP professionals from academia, biotech, and industry
- Gain visibility for your work within the growing ATMP community in the Netherlands and beyond
- Tbd Best Poster Award
Let’s accelerate innovation — one poster at a time.
Deadline for abstract submission: 1st February 2026
Notification of acceptance: 15th February 2026
Presentations
From scientific discovery to GMP – preparing ATMP manufacturing for 2030.
Edwin van den Bos - Progress - Experts in Life Sciences
Towards ATMP 2030: Building Continuous Validation Frameworks on Strong CQA Foundations
Thilo Buck - Progress - Experts in Life Sciences
Advanced gene editing therapies push traditional validation beyond its limits. Small shifts in gRNA chemistry, delivery modality, or patient-specific starting material can cascade through CQAs—potency, specificity, viability, editing profile—in ways that classic CPP-based models cannot predict. This makes ATMPs, and especially n=1 gene editing therapies, inherently difficult with static, document-driven validation approaches. This talk outlines how a CMA–CQA–CPP–CS framework grounded in QbD supports a more adaptive and science-driven validation strategy, and why Process Analytical Technology (PAT) is becoming essential to generate the structured, real-time data required for lifecycle control. Building on this foundation, we explain how a manufacturing digital twin—combining mechanistic understanding, DoE data, PAT signals, and statistical learning—can continuously re-establish process understanding as biology shifts. By simulating donor variability, predicting how molecular or cellular changes propagate into CQAs, and quantifying uncertainty, digital twins provide the scientific justification needed for Continuous Validation of highly variable ATMP processes. This enables a future in which ATMP manufacturing is not only compliant, but truly future-proof, with control strategies that update as fast as the science evolves.
Off-the-shelf T Cell Receptor-based Natural Killer cells for the treatment of solid cancer.
Namir Hassan – Zelluna ASA
Allogeneic “off-the-shelf” cell therapies hold great promise for making advanced immunotherapies more scalable and accessible, particularly in solid tumours where existing approaches still face major limitations. In this presentation, Namir Hassan will introduce Zelluna’s TCR-NK platform and its lead program ZI-MA4-1, which combines the innate killing capacity of NK cells with the precision targeting of TCRs against the MAGE-A4 tumour antigen. He will outline the translational path toward first-in-human studies in the UK, highlighting key considerations in preclinical development, manufacturing, and regulatory interaction. The talk will focus on how scalable production, robust quality control and early alignment with agencies such as the MHRA are essential to bringing next-generation allogeneic ATMPs safely and efficiently to patients with solid tumours.
Next generation ATMPs: Translating CRISPR Science into Scalable Therapies
Prof. Niels Geijsen - Leiden University Medical Center & Ester Wijer PhD - NTrans Technologies
The rapid evolution of CRISPR-based gene editing technologies is reshaping the landscape of regenerative medicine and advanced therapy manufacturing. In this joint presentation, Prof. Niels Geijsen (LUMC) and Dr. Ester Weijers (NTrans Technologies) explore how the next generation of gene editing platforms can be made future-proof — scalable, safe, and compliant with GMP standards. Prof. Geijsen will highlight recent advances in CRISPR-mediated editing in pluripotent stem cells and muscle regeneration, outlining the scientific and technical hurdles that remain when moving from discovery to clinical application. Dr. Weijers will then discuss NTrans’ novel non-viral delivery technology, designed to enable precise and efficient gene editing. Together, they illustrate a translational pathway — from bench to biotech — showing how academic innovation and entrepreneurial execution can jointly drive the next wave of personalized, gene-edited therapies in oncology and regenerative medicine.
Reinventing AAV Manufacturing: Synthetic Biology Meets ATMP Scalability
Benjamin Blaha – Fuse Vector
AAV manufacturing has long been limited by the inherent constraints of cellular production systems — variability, scalability challenges, and process bottlenecks that slow down innovation. In this presentation, Fuse Vectors’ leadership will introduce their fully cell-free, enzymatic AAV manufacturing platform designed to overcome these limitations. They will highlight how building viral vectors outside the cell enables superior consistency, improved vector quality, and a pathway to dramatically faster development cycles. The talk will also showcase the Fuse Foundry — a high-throughput R&D engine for rapid, parallel recipe screening — together with the Fuse Scale-Up platform, designed to deliver seamless progression from discovery to GMP readiness. Together, these innovations represent a new paradigm for vector engineering and manufacturing, with the potential to transform the economics and speed of gene therapy development.
The use of NGS for characterization and viral safety
Erik Splinter PhD – Solvias
Next-generation sequencing (NGS) is rapidly transforming viral safety testing by offering a faster, more sensitive, and more comprehensive alternative to traditional cell-based viral assays. In this presentation, Solvias will demonstrate how NGS-based viral detection enables unbiased identification of known and unknown viral contaminants, shortening timelines and improving reliability in the development of ATMPs. Erik Splinter will highlight recent advances in deep-sequencing analytics, discuss regulatory expectations for NGS viral safety data, and illustrate how integrated genomic QC can reduce risk, increase process understanding, and ultimately support safer, more robust manufacturing of gene and cell therapies.
Location of Dutch ATMP Summit
Corpus
Willem Enthovenstraat 1
2342 BH Oegstgeest
+31 (0) 23 563 50 16
(Progress Head Office)
Willem Einthovenstraat 1, 2342 BH Oegstgeest
This year's edition of the Dutch ATMP Summit takes place at Corpus Leiden
Location of Dutch ATMP Summit
Corpus
Willem Enthovenstraat 1
2342 BH Oegstgeest
+31 (0) 23 563 50 16
(Progress Head Office)
About us
This summit is an initiative from Progress - Experts in Life Sciences
We work together with our clients, in order to obtain their goals. We work as a team to reach to the top. Progress is an independent consultancy company with customers in the pharmaceutical and biotechnology industries and in the healthcare sector. We provide project management, engineering & C&Q, CMC and Quality services.
About us
This summit is an initiative from Progress - Experts in Life Sciences
We work together with our clients, in order to obtain their goals. We work as a team to reach to the top. Progress is an independent consultancy company with customers in the pharmaceutical and biotechnology industries and in the healthcare sector. We operate internationally, project management, engineering & C&Q, CMC and Quality services.