Dutch ATMP Summit
Automation in ATMP manufacturing
Dutch ATMP Summit Manufacturing
2025
2025
Recap of the day
The 2025 edition of the Dutch ATMP Summit successfully concluded, highlighting the transformative impact of automation in Advanced Therapy Medicinal Products (ATMP) manufacturing. This year’s event focused on cutting-edge technologies that enhance efficiency, minimize errors, and enable scalable production.
Key highlights included expert insights on the latest automation solutions, real-world case studies showcasing their implementation, and strategies to overcome challenges in integrating automation into ATMP manufacturing. Interactive Q&A sessions provided a platform for in-depth discussions, fostering practical takeaways for industry professionals.
The summit once again proved to be a crucial meeting point for the ATMP community, facilitating knowledge exchange, inspiring innovation, and strengthening collaborations to drive the future of advanced therapy manufacturing.
Watch the aftermovie
Event highlights at a glance
116
Attendees
54
Attendees from industry
25%
Attendees from big pharma
On average the participants of the 2025 edition rated the Dutch ATMP Summit with a 8,2
- “Very informative”
- “Interesting overview of developments.”
- “An interesting day full of exciting new insights.”
- “Great way to expand knowledge and meet people.”
- “Its a great event!”
Some of the participants of the 2025 edition
Speakers
Dr. Thijs Booiman
Senior Consultant
Progress Experts in Life Sciences
Thijs Booiman started working at Progress in May 2023. He obtained his PhD in virology and immunology at the University of Amsterdam. After completing his post-doctoral research he worked for Eurofins MicroSafe in the role of study manager and department head. There he was responsible for the tech transfer and validation of various quality control methods for the testing of biologicals. After Eurofins he worked at HALIX as a project manager responsible for the tech transfer, development and manufacturing of several antibodies and viral vectors. In 2021 he moved to NecstGen as lead scientist quality control for ATMPs. In this role he was responsible for setting up the quality control department, LIMS implementation, clean room PQ execution and the implementation of microbial and rapid qc methods.
Dr. Mark Duerkop
Chief Executive Officer
novasign
With more than 15 years of experience, Mark is a passionate expert in biopharmaceutical process development. He worked together with several Pharma companies in different projects, targeting their process development and understanding needs. After finishing his PhD in the Field of Bioprocess Development in the laboratory of Alois Jungbauer, Mark decided to found a company focusing on the field of bioprocess modeling. Leading Novasign as CEO, Mark and his team develop a hybrid modeling software for both up and downstream processes. This software utilizes AI applied to process data and first-principle models (hybrid models) to faster and better predict critical quality attributes (CQAs) from critical process parameters (CPPs). Hereby, bioprocess development and characterization are accelerated significantly while a better process understanding is gathered. The company Novasign was founded in 2019 offering this unique software solution which is already in use by several TOP25 pharma companies to also accelerate their process development.
Evan Claes MSc
ATMP Monitoring &
Control Architect at Antleron
Evan has close to a decade of experience in the ATMP sector, specializing in innovative approaches to process monitoring and optimization. His work involves soft sensing and hybrid process modelling, supporting the development of scalable and sustainable biomanufacturing solutions. Most of this work was done at Antleron, a company operating at the intersection of life sciences and digital technologies, offering personalized and digitalized manufacturing solutions for advanced therapies. Based in Leuven, the company has been an important contributor to Europe’s thriving biotech ecosystem for 10 years. With its state-of-the-art facilities, multidisciplinary team, and focus on innovative R&D, Antleron provides transformative technology solutions that enable affordable, scalable, and customized bioprocesses for advanced therapies.
Dr. Janet Hoogstraate
Chief Executive Officer
NorthX Biologics
Janet Hoogstraate is CEO of NorthX Biologics AB since September 2023. She has a PhD in Bio-Pharmaceutical Sciences from Leiden University, did academic research at the University of Utah and University of Iowa. She has an executive MBA from Hult International business school in London.
Janet has worked over 25 years in the pharmaceutical industry with various leadership roles at AstraZeneca working in neuroscience and pain, followed by setting up a Science Park at Acturum Life Sciences and leading a commercial and clinical vaccine manufacturing site as Managing Director at Valneva Sweden. Janet is a board member of 3 European life science companies. Today, she works at NorthX Biologics, a Swedish national innovation hub and CDMO for advanced biologics in Sweden.
Dr. ir. Marieke Klijn
Assistant Professor Data-Driven Bioprocess Development at Technische Universiteit Delft
After a MSc in Biochemical Engineering and a PhD in protein analytics and machine learning, Marieke established a research group in 2020 at Delft University of Technology with a focus on applying advanced analytics to understand, develop, and control bioprocesses. The topics in her research group range from microbial fermentation to ATMP production, where synergy is found in the application of in-line analytics, development of technology to speed up data-driven modelling, and work towards data-driven control strategies.
Ramon van Valderen MSc
scale-up at Technische Universiteit Delft
Ramon obtained his MSc in Biochemical Engineering at Delft University of Technology, with a specific focus on mathematical modelling and machine learning. After that, he continued in Delft for a PhD in the department of Bioprocessing, where he is currently focused on using Computational Fluid Dynamics (CFD) models for upscaling cell culture processes in bioreactors.
Dr. Marc Kamp
Kite, a Gilead company
Details will follow soon.
Jacek Lubelski, PhD, MBA
Chief Technology Officer
NanoCell Therapeutics
Mr. Lubelski is an accomplished biopharmaceutical leader, researcher and pharmaceutical developer specializing in gene and cell therapy and viral vector production. With over a decade-long career, he has made significant contributions to the development and advancement of gene therapy technologies, particularly in the field of recombinant adeno-associated virus (rAAV) therapeutics.
Prior to joining NanoCell Therapeutics, Mr. Lubelski served as the VP of Pharmaceutical Development at UniQure NV (NASDAQ: QURE). He has contributed to obtaining market authorization for Glybera, the first approved gene therapy medicine in the Western World, to treat lipoprotein lipase ( LPL) deficiency and market authorization of Hemgenix to treat Haemophilia B. He has been instrumental in developing multiple rAAV-based translational advanced therapy medicinal products (ATMPs) to address challenging diseases like Haemophilia B, Sanphilipo B, and Acute Intermittent Porfyria. As Vice President of Development, Mr. Lubelski also led vector process and analytical development as well as , pre-clinical studies, and CMC activities focused on rAAV-based therapies. His expertise in leading complex teams across Europe and the USA has resulted in successful design and implementation of technological processes and analytical methods for viral vector manufacturing platforms.
In his current role as the Chief Technology Officer at NanoCell Therapeutics, Mr. Lubelski spearheads all research and development activities. Dr. Lubelski was also selected as an expert by the European Directorate for the Quality of Medicines & Healthcare (EDQM) He has coauthored more then 20 scientific publications as well as multiple patent applications pertaining to gene therapy filed.
Mr. Lubelski holds a Ph.D. in Molecular Microbiology from the University of Groningen, a Master's degree in Biotechnology from Maria Curie-Sklodowska University in Lublin, Poland and an MBA degree from the Rotterdam School of Management, Erasmus University in Rotterdam, the Netherlands.
Speakers
Speakers
Dr. ir. Marieke Klijn
Asst Professor Data-Driven Bioprocess Development at TU Delft
Dr. Marc Kamp
Director Quality Engineering and Program Lead GxP Quality Cell Therapy at Kite, a Gilead company
Topics of the summit
Review of the Market on QC Automation in ATMP Manufacturing
Dr. Thijs Booiman - Progress - Experts in Life Sciences
Over the past 25 years, Progress – Experts in Life Sciences has collaborated with numerous clients to design, build, and operationally release pharmaceutical facilities for both bulk non-ATMPs and ATMPs. During the presentation, Thijs provided an in-depth analysis of current market trends in Quality Control (QC) automation, highlighted advancements in technology, and discussed the challenges associated with implementation.
Accelerating ATMP process development: in-line analytics and CFD simulations
Dr. ir. Marieke Klijn, Assistant Professor Data-Driven Bioprocess Development - TU Delft with Ramon van Valderen, PhD Candidate CFD modelling for ATMP scale-up - TU Delft
In this duo presentation, we showcased how we approach the implementation of novel analytical and computational techniques to accelerate bioprocess development. We discussed our pursuit of in-line analytics, such as Raman spectroscopy, to gain more in-depth process understanding, as well as our approach to designing scalable ATMP processes from a fundamental engineering perspective using advanced in-silico simulation techniques, such as computational fluid dynamics. For both types of technologies, we explored current research efforts to demonstrate their impact on process development and the challenges we have encountered along the way.
Digital-Twin assisted Biomanufacturing: From accelerated Process Development to automated Process Control
Dr. Mark Duerkop - Novasign GmbH with Evan Claes - Antleron
This presentation highlighted how smart experimental design combined with advanced process modeling techniques can reduce the number of lab experiments by up to 70% in the process development of ATMP manufacturing. We explored how these modeling techniques can be applied within the Quality by Design (QbD) framework (see ICH Q8) to ensure that product quality is established from the outset through a comprehensive understanding and control of variables.
Additionally, we discussed the use of novel Design of Experiments (DoE) techniques to systematically explore the relationships between multiple factors, optimizing processes efficiently. The presentation also demonstrated how digital twins—virtual models of physical processes—facilitate easier scale-up, enable automated process control, and increase productivity while reducing costs. These concepts were illustrated with an industry-relevant case study by Antleron, showcasing how a hybrid cell growth model combined with a Cost-of-Goods model in a digital twin of a fixed-bed bioreactor expansion process led to a reduction in both process development costs and time while improving productivity.
How to set-up the GMP production of a cell therapy for Acute Myeloid Leukemia (AML) including automation in manufacturing, QC & release testing
Dr. Janet Hoogstraate - NorthX Biologics
Before innovative therapies can be tested in clinical studies, the hurdle of progressing to GMP manufacturing must first be overcome. This process requires the right expertise, takes time, and can impose substantial costs on the development program. During the presentation, we highlighted how collaboration between innovation and manufacturing experts increases the probability of success in bringing advanced therapies to patients. Additionally, we emphasized that early commitment to standardization, automation, and efficiency improvements can significantly accelerate the transition from idea to GMP manufacturing.
Implementation of automation in CAR T cell therapy production
Dr. Marc Kamp - Kite, a Gilead company
Like all cell therapy companies, Kite is in the process implementing automation in their commercialized manufacturing supply chain across the globe. In general, technology adoption in cell therapy has its challenges that will be discussed during the presentation.
Novel Non-Viral DNA-based Gene Therapy vector for CAR T engineering in vivo
Jacek Lubelski PhD, MBA - NanoCell Therapeutics
Ex-vivo modification of immune cells to express Chimeric Antigen Receptor (CAR) has shown tremendous clinical and commercial success as a cancer treatment. Although widely adopted, ex-vivo CAR-T approaches are not without their challenges. Soaring production expenses, extended timelines, inherent toxicity risks, and the operational intricacies of today’s conventional cell therapy treatment models call for a next wave of improvements.
In the presentation, we showcased a novel cell-targeted lipid nanoparticle (tLNP) that can deliver both DNA and RNA to T cells. This new tLNP-based vector consists of an LNP formulation containing transposon DNA (encoding for CAR), mRNA (encoding for transposase), and activating and targeting protein moieties. We discussed the ability of this vector to activate resting primary T cells, thereby allowing their permanent modification with a DNA-encoded CAR construct in vitro in the absence of exogenous activation, resulting in the generation of fully functional CAR-T cells.
In addition, we presented the capacity of this non-viral vehicle to drive the generation of functional T-cells in vivo. We demonstrated the generation of persistent CAR-T cells, tumor control, and extended survival after tLNP treatment in a human PBMC-engrafted NSG mouse model injected with a human B-cell leukemia cell line. We believe that the CAR-T cells generated in vivo have a variety of advantages compared to currently employed ex-vivo manufacturing technologies.