From design to delivery: outcomes from the SMARTER project

SMARTER is a European Commission and Innovate UK funded project that aims to develop a smart manufacturing platform for personalised cell therapies. 

Previously, the consortium had successfully transferred a Tumour-infiltrating lymphocyte (TIL) manufacturing process into a dynamic stir-tank bioreactor system enabling integration of Process analytical technology (PAT) biosensors such as Raman Spectroscopy and 2D fluorescence. Using a TIL-like healthy donor model in this system, we applied complex design of experiment (DoE) approaches to screen and validate critical process paraments (CPPs) identified through metabolomics studies performed at the Hospital Universitario La Fe (HULAFE) in Spain, process development studies at the CGT Catapult, and literature research. These DoE studies enabled us to develop an improved process with better cell expansion and cell reactivity. 

Furthermore, the consortium had successfully achieved the integration of both Raman spectroscopy and 2D fluorescence sensor systems, which are used for real-time process monitoring and implementation of an adaptive control strategy.  Lastly, it had set up a digital infrastructure at the CGT Catapult’s labs, enabling continued digitalisation of the cell and gene therapy sector. Part of the digital infrastructure set up included the integration of a 2D fluorescence sensor system developed at the University of Hannover (LUH) into the bioprocess platform. Multiplexing of flow cells for online fluorescence measurements is enabling the development of an online cell count model to be available for up to four vessels simultaneously. This will be used for automated process control.

The CGT Catapult team has been busy over the last few months designing and implementing experiments that aim to demonstrate a proof-of-concept of adaptive process control. With the support of the Partner in Hannover (LUH), we created in silico simulations of model-based bioprocess optimisation that enabled us to significantly shorten the process time by four days while maintaining the required product’s critical quality attributes.

Last December, the CGT Catapult completed the final run of the SMARTER project. This milestone was particularly significant as patient material was used for the first time. PAT-mediated advanced process control strategies, previously developed using healthy donor material, were successfully demonstrated with real-world patient samples, allowing the team to draw valuable conclusions on the translation of PAT technologies and smart bioprocessing to complex cell therapy development.

Follow the SMARTER project on LinkedIn and visit its website for regular updates:

SMARTER LinkedIn: https://www.linkedin.com/company/smarterproject/
SMARTER Website: https://smarter-project.eu/news/

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A first-in-class smart bioprocessing manufacturing platform for personalised autologous cell therapies

Funding statement

This project has received funding from the European Union’s Horizon Europe research and innovation programme under grant number 101071054. Views and opinions expressed are those of the author(s) only and do not necessarily reflect those of the European Union or European Innovation Council. Neither the European Union nor the granting authority can be held responsible for them.

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Dr Maria Vila de Mucha

Senior Scientist I

Achilles Therapeutics UK Limited

Maria has a background in tumour immunology, with a particular focus on tumour-infiltrating T cells. She obtained her BA in Biomedical Sciences from the University of Oxford in 2015, after which she worked as a research assistant in the department of Haemato-oncology at Barts Cancer Institute, London. After this, she went on to study for her PhD at the UCL Cancer Institute, which focused on the mechanisms regulating the differentiation of cytotoxic CD4+ T cells in tumours. After completing her PhD in 2021, she continued her work at UCL in a post-doctoral position. She joined Achilles in 2024, working in the Immunology Research Team. She is part of the technical team from Achilles on the SMARTER project, providing expertise on T cell biology.

Maribel Alcoriza-Balaguer

PhD student at BPMU, responsible of bioinformatics analysis

Health Research Institute of the Hospital La Fe

Maribel Alcoriza Balaguer obtained a Biochemistry degree from the University of Valencia (Spain) in 2015 and a Master Degree in Bioinformatics in 2017. Currently, she is a PhD student in the Biomarkers and Precision Medicine Unit at the Health Research Institute Hospital La Fe and her research has focused on the application and development of bioinformatic tools for the analysis of metabolomics and lipidomics data. Maribel will help in the LC-MS based metabolomics analysis of the samples and will be responsible of the bioinformatics analysis of the LC-MS data. 

Dr. Juan Carlos Garcia-Cañaveras

Post-doctoral researcher at BPMU, responsible of metabolomics analysis

Health Research Institute of the Hospital La Fe

Dr. Juan Carlos Garcia-Cañaveras obtained his degree in Biochemistry (2009) and his PhD in Biochemistry and Biomedicine (2015) from the University of Valencia (Spain). In 2017, he obtained a Marie Sklodowska Curie Actions Global Fellowship that was developed in the Rabinowitz lab (Princeton University, USA) and the Biomarkers and Precision Medicine Unit (IIS-La Fe), where he is currently a post-doctoral researcher. His research has been focused on the development of “targeted” and “untargeted” LC-MS-based metabolomic and lipidomic approaches, the development of bioinformatic tools for the analysis of metabolomics and lipidomics data and the use of isotope tracers coupled to MS-based detection to study cancer and T cell metabolism. Juan Carlos will be responsible for the LC-MS based metabolomics analysis of the samples generated within the SMARTER project. 

Dr. Agustin Lahoz

Group Leader of BPMU and Scientific Director of the Metabolomics Facility

Health Research Institute of the Hospital La Fe

Dr. Agustín Lahoz holds a PhD in Pharmacy (Organic Chemistry) and a MSc in Biostatistics from the University of Valencia. He is the leader of the Biomarkers and Precision Medicine Unit and the Scientific Director of the Metabolomics Core Facility at the Health Research Institute Hospital La Fe. Agustín Lahoz’s laboratory aims to develop and applicate mass spectrometry and stable isotope-assisted metabolomics for studying cellular metabolism and biomarker discovery. Currently, his group focuses on modulating cancer cell metabolism and immune metabolism as avenues for developing more effective therapies. Agustin Lahoz is the coordinator of the work developed at IIS-La Fe within the SMARTER project.  

Dr. Katy Newton

SVP, Immunology and Process Development

Achilles Therapeutics UK Limited

Dr Katy Newton obtained her BSc in Biochemistry with Applied Molecular Biology at UMIST in Manchester in 2001. She went on to study for her PhD at the Institute of Child Health (UCL/GOSH) in T cell and Dendritic cell immunology in the context of Vaccines which she obtained in 2005. Following a post-doctoral position, working on T cell responses in Meningitis B vaccine trials she moved in 2007 to be one of the first employees of a T cell therapy start-up company called Cell Medica, one of the first such companies in the UK. Katy spent the next almost 10 years developing novel products and processes and managing GMP production of autologous T cell therapies to CMV and ADV in the context of bone marrow transplants and EBV associated cancers with sites in the UK, Germany, and Texas, USA. She became VP of process development and managed the immune monitoring for the clinical trials. In 2016 Katy joined Achilles Therapeutics as VP of process development responsible for the proof of concept and design of a novel neoantigen specific T cell therapy. She is now SVP of Immunology and Process Development at Achilles, responsible for the research, process development and translational science teams. As part of SMARTER, Katy has oversight of the work generating the model system and subsequent analysis of the products generated using the refined manufacturing process.

Alexia Toufexi

Manufacturing Science and Technology (MSAT) Scientist II

Achilles Therapeutics UK Limited

Alexia Toufexi obtained her MSc in Biotechnology (2015) from Imperial College London (UK). In 2017, she joined Cell and Gene Therapy Catapult where she specialised in immunotherapies being involved in USP/DSP bioprocessing and automation projects. In 2022, she moved to Achilles Therapeutics as part of the MSAT/GMP team optimising and manufacturing the Achilles process. As part of the SMARTER project, Alexia is involved in the technical side; tech transferring the Achilles process to the partners and generating the material required for the project. In parallel, she works with the collaborators to adapt the Achilles process to APC-platforms and gain process understanding from the data generated.

Dr. Max Salm

Director, Bioinformatics

Achilles Therapeutics UK Limited

Max has over 20 years of experience in clinical genomics in both academic and industry settings. At Achilles Therapeutics, Max leads the Bioinformatics Research efforts focused on the design, development and delivery of research initiatives that optimize the performance of the PELEUS™ bioinformatics platform. This platform guides the production of clonal neoantigen targeting T cells, a personalized therapy for advanced non-small-cell lung carcinoma and melanoma being evaluated in successive Phase I/II trials (NCT03517917; NCT03997474; NCT04032847). Prior to joining Achilles Therapeutics, Max was a lead analyst and project manager at Thomson Reuter’s Discovery Science Group where he was responsible for delivering innovative bioinformatics oncogenomic and systems biology solutions to international pharmaceutical clients such as Takeda, Johnson & Johnson, and Merck. Before this, Max was an analyst at the CRUK London Research (now Crick) Institute’s  Bioinformatics and Biostatistics Group, in which he primarily focused on developing novel approaches and pipelines to comprehensively characterize genomic variation and intra-tumor heterogeneity using whole genome and whole exome sequencing in a variety of indications, including non–small-cell lung cancer (as part of the TracerX consortium), clear cell/papillary renal cell carcinoma, glioblastoma, esophageal adenocarcinoma and acute myeloid leukemia. Max additionally completed postdoctoral work in cardiovascular genomics at Barts and the London School of Medicine and Dentistry, and forward and reverse genetics projects in audio vestibular genomics at the Welcome Trust Sanger Institute. Max holds an inter-disciplinary PhD in Medical Genetics from Imperial College, in which he developed in vitro and in silico tools to characterize genomic structural variation.

Dr. Pablo Becker

Head of Immunology Research

Achilles Therapeutics UK Limited

Pablo has over 20 years of experience in immunological therapies. At Achilles Therapeutics, Pablo leads the Immunology Research team. The focus is to develop new concepts to improve the next generation of cellular therapies at Achilles. Before joining Achilles, Pablo’s work focussed on vaccine development against pathogens and tumours. Pablo has a biochemistry degree from the University of Buenos Aires and started his research developing vaccine candidates to children’s pathogens at the Children’s Hospital Ricardo Gutierrez, Argentina and continued his work later at the Helmholtz Centre for Infection Research, Germany, where he obtained his PhD, generating new vaccination strategies with novel adjuvants and delivery systems to improve immune responses. He worked as part of 2 consortiums (in Germany and UK) supported by the Bill and Melinda Gates Foundation in the context of the “Grand Challenges in Global Health” initiative to develop models and evaluate vaccine candidates against HCV and HIV. At King’s College London, Pablo focused on understanding T cell responses to epitope cross-reactivity to increase the breadth and depth of T cell responses using different viruses as delivery systems, before joining the Medical Research Council (MRC) Centre for Transplantation, where he focused on the generation of cellular therapies to induce transplantation tolerance.

Dr. Henrieta Fraser

VP, Technical Operations

Achilles Therapeutics UK Limited

Henrieta Fraser, PhD is a VP of Technical Operations at Achilles Therapeutics, one of the leading companies in development of immunotherapies.

Henrieta graduated in Molecular Biology and Genetics from the Faculty of Natural Sciences, Comenius University, Bratislava, Slovakia. She continued with her studies at the Faculty of Medicine where she obtained her PhD in Immunogenetics. To further pursue her carrier, she moved to London where she joined the group of Prof. Robert Lecher and Prof. Giovanna Lombardi at Imperial College and later at King’s College London. Here she worked on several basic research projects from characterising Complement Factors, investigating mechanism of Chronic Beryllium Disease, tolerogenic properties of different subsets of DCs, potential clinical use of placental MSCs and regulatory T cells. The last 6 years at KCL Henrieta’s interest was redirected to translational research particularly to the development of Treg cell therapy for prevention of graft rejection in solid organ transplantation. In April 2014 she left academia to join the Cell and Gene therapy Catapult as a Senior process development scientist. She oversaw several projects focusing mainly on development of T cell-based therapies as well as therapies using DCs and MCS. In May 2017 she joined Achilles Therapeutics as a GMP production manager. She progressed in her career to the VP of Technical Operations and currently oversees the manufacture of clinical product for ongoing clinical trials and leads the MSAT team in improving product manufacturability by implementation of process improvements and automation.

Dr. Nicola Goddard

Principal Manufacturing Science and Technology (MSAT) Scientist I

Achilles Therapeutics UK Limited

Dr Nicola Goddard obtained her PhD on the manufacture of red blood cells from stem cells from Heriot Watt University (Scotland) in 2016. At this time, she moved to the Biochemical Engineering department at University College London to complete Postdoctoral studies on the generation of neural stem cell exosomes. Both projects featured design and execution of automated screening platforms for identification of optimal conditions for scale-up, which were then successfully transferred to clinically relevant platforms. In 2019 Nicola moved to Achilles Therapeutics Ltd, specialising in Process Automation; adapting, and translating elements of Achilles’ clinical manufacture process to automated platforms. On this project Nicola acts as Technical Lead for Achilles, providing expertise in adapting the Achilles co-culture process to APC-compatible platforms, as well as designing project-specific analytical packages and data visualisation.

Dr. Mariana Werner Sunderland

Senior Scientist II

Achilles Therapeutics UK Limited

Mariana has a background in genomics and immunology. She obtained her BSc in Genomic Sciences from the National Autonomous University of Mexico (UNAM) in 2014. During this time, she did a 10-month internship at Steve Pollard’s lab in the MRC Centre for Regenerative Medicine at the University of Edinburgh. Here she worked on genome editing of glioblastoma (GBM) cell lines. She then joined Sergio Quezada’s lab and went on to obtain her PhD on cancer immunotherapy in 2019 from University College London (UCL), where she focused her research on gene editing of tumour infiltrating lymphocytes for the generation of adoptive cellular therapeutics against cancer. Since 2019 she has been working at Achilles Therapeutics Ltd in the immunology research team of the process development department.

On the SMARTER project, Mariana acts as the PM for Achilles and is the project coordinator, as well as being part of the technical team for Achilles, providing immunological expertise in Achilles’ co-culture process and products.

Dr. Vishal Sharma

Head of CMC Programme Management

Achilles Therapeutics UK Limited

Dr. Vishal Sharma obtained his degree in Immunology and Molecular Pathology from University College (UCL) London (UK) in 2004. He spent 6 years working within Biotechs such as Amaxa Biosystems (now Lonza) to bring nucleofection technology and automated cell phenotyping and analytical technologies to cell biology researchers across the UK and Europe. In 2010 Vishal re-joined academia to focus on the industrialisation of cell therapy manufacturing processes in regenerative medicine and earn his Engineering Doctorate in the department of Biochemical Engineering at UCL in 2015. He spent the following 2 years with Fios Genomics to bring automated bioinformatics data analyses workflows to pharma, biotech and particularly the cell therapy field before joining the Cell and Gene Therapy Catapult (CGTC) in 2017. Vishal spent 4.5 years at CGTC managing cell therapy programmes spanning all phases of development from research, clinical trials through to commercialisation within the growing CGT industry in the UK. He now works at Achilles Therapeutics as Head of CMC Programme Management and supports delivery of the SMARTER Project alongside Achilles’ other manufacturing focused projects and programmes.

Saadat Wadud

Technician

Cell Therapy Catapult Limited

Saadat Wadud obtained his Meng in Biochemical Engineering from UCL in 2021 where he had extensive experience designing bioprocesses for stem cells, mammalian cells, and immune cells. His Master’s project involved applying gene editing to watermark cells in order to prove intellectual property. He joined Cell and Gene Therapy Catapult straight out of university as a technician. At CGTC he works primarily in upstream bioprocessing with gene therapies and both autologous and allogeneic cell therapies across a variety of bioreactor platforms. Saadat will be assisting the STR process development on the SMARTER project.

Mateusz Filipiak

Associate Scientist

Cell Therapy Catapult Limited

Mateusz Filipiak obtained his degree in Biological Sciences (2018) from the University of Essex and then completed an MRes in Biomedical Research (2019) at Imperial College London. He currently works as an Associate Scientist in the Technology and Process Innovation team within the Cell and Gene Therapy Catapult. While at Catapult he has worked across a range of areas including analytical development, immunotherapies and bioprocessing with the skills from the latter being used to help in the upstream bioprocessing side of WP3 and WP5 of the SMARTER project.

Dr. Chris O’Grady

Associate Senior Data Scientist

Cell Therapy Catapult Limited

Dr. Chris O’Grady obtained his degree in Biological Sciences from the University of Warwick in 2015. He continued studying at the University of Warwick until 2019, where he completed a PhD in modelling the structure and function of microbial communities in agricultural soils. During this time, Chris developed novel bioinformatics and imaging pipelines to predict functional significance of microbial taxa in complex communities. In 2019, Chris joined Cell and Gene Therapy Catapult as a Data Scientist in the TPI team. Since then, he has helped build and manage CGTC’s cloud-computing architecture and has been heavily involved in developing bioinformatic pipelines that analyse many types of -omics data sets from numerous technologies. Chris will assist with the processing and analysis of the RAMAN data on the SMARTER project.

Nicolyn Thompson

Scientist

Cell Therapy Catapult Limited

Nicolyn Thompson undertook her BSc in Biochemistry at the University of Westminster (2008), followed by an MSc in Immunology at King’s College London (2009). She worked as a Research Assistant at Queen Mary University of London, Blizard Institute (2013), and briefly at the London School of Hygiene & Tropical Medicine as a Voluntary Researcher (2014). She gained a PhD in Immunity at the University College London (2018). Upon completion of her studies, she undertook the position of a Research Associate at Cell Medica Ltd (2019) and a role as a Scientist at Oribiotech Ltd (2020). She has worked in the bioprocess and analytical development sphere and has a wealth of skills in cell and gene therapy, immunology, autoimmunity, primary human cells isolation, cell culture and immunophenotyping. She joined Cell and Gene Therapy Catapult in 2020, as an Immunology Scientist (CGTC). She works primarily in the bioprocessing sphere in designing and running multi-colour flow cytometry panels, culturing of primary human cells and cell lines, transduction, and data analytics.

Patrick Statham

Scientist

Cell Therapy Catapult Limited

Patrick Statham obtained his degree in Biochemistry from the University of Manchester in 2017. During the degree, he spent a year at the University of South Australia working on a cell therapy product for wound healing applications. He completed a PhD in Tissue Engineering and Regenerative Medicine from the University of Leeds (2021), investigating decellularised scaffolds to support autologous cell therapies for cartilage repair.  He joined Cell and Gene Therapy Catapult in 2021, as a Bioprocessing Scientist (CGTC). At CGTC he works in Upstream Bioprocessing with autologous and allogeneic cell therapies across a range of bioreactor platforms, specialising in transitioning 2D open process into 3D closed processes. Patrick will be responsible for the STR process development on the Achilles SMARTER project. 

Chathyan Pararasa

Scientist

Cell Therapy Catapult Limited

Marcia Mata

Associate Lead Scientist

Cell Therapy Catapult Limited

Marcia is an experienced Biological Engineer and holds a PhD in Biotechnology from Instituto Superior Tecnico (Lisbon, Portugal). She has over 10 years’ experience in upstream bioprocessing on the cell and gene therapy field and has joined Cell and Gene Therapy Catapult in 2017, as a Scientist. Now, currently an Associate Lead at the Cell and Gene Therapy Catapult, she has supported bioprocessing efforts across the CGTC programmes, aiming to develop end to end closed and scalable platforms for the production of affordable advanced therapies, within iPSC, Immuno and Gene Therapy, including extensive experience of scaling up/down of processes. Due to this, she has become a SME on Upstream and Bioreactor operations within the company and has been leading the bioprocessing process translation within the SMARTER project.

John Churchwell

Associate Lead Scientist

Cell Therapy Catapult Limited

John Churchwell completed his PhD in physical chemistry at Durham University in the UK, focussing on the spectroscopy of interfaces. He went on to a postdoctoral position at University College London, applying spatially offset Raman spectroscopy (SORS) for the diagnosis of bone disease both in vivo and ex vivo. During this time, he received an EPSRC secondment to work with collaborators at the Central Laser Facility, part of the STFC Rutherford Appleton Laboratory, to develop novel chemometric methods. He is a member of the editorial advisory board for the Journal of Raman Spectroscopy. In his current role as Associate Lead Scientist at the Cell and Gene Therapy Catapult he leads on the application of process analytical technology (PAT), chemometrics and advanced process control for the industrialisation of advanced therapies and supports digitalisation initiatives and the implementation of industry 4.0. John has extensive experience in the application of new process analytical technologies for monitoring and control of ATMP processes including viral vectors and autologous immunotherapies. John is inventor on two patents relating to methods for monitoring viral vector production processes with Raman spectroscopy.

Panos Papoutsis

Project Manager

Cell Therapy Catapult Limited

Panos Papoutsis is a certified Project Manager (PMP, PMI-ACP) and holds a bachelor’s in Public Administration from the Panteion University of Social and Political Sciences and a Master of Arts degree in European Studies, from the University of Reading in the UK. Since 2007, he has participated in various research projects, mainly in the fields of health and education, under the H2020, Erasmus+, FP6, CIP, and Lifelong Learning Programme as Project Manager, supporting all project aspects (including financial, administrative or dissemination aspects). Moreover, he has been the Financial Manager (financial programming, reporting & recording) in more than 35 EU & National projects for the University of Athens, private secondary education establishments and NGOs. Prior to joining Catapult in May 2022, Panos was a Project Manager for University College London (UCL) for almost 5 years, managing H2020 collaborative health projects from a coordinator’s point of view. Panos is the Project Manager for Catapult.

Vincenzo Di Cerbo

Lead Scientist

Cell Therapy Catapult Limited

Dr Vincenzo Di Cerbo, Lead Scientist, has 15 years of R&D experience within basic science and applied fields. His expertise includes development of novel analytics, cell engineering and multi-omics data analysis applied to the development of various cell and gene therapy areas encompassing viral vectors, immuno-oncology and pluripotent stem cells. Dr Di Cerbo joined Cell and Gene Therapy Catapult in 2017 and he is currently leading a programme aiming at enhancing cell and gene therapy design, bioprocessing, and characterisation through the utilisation of viral and non-viral delivery systems, cell engineering, multi-omics and in-process control approaches. Dr Di Cerbo holds a PhD from the Max-Plank Institute of Immunology and Epigenetics in Freiburg (Germany) and has completed a postdoc at Oxford University studying chromatin and transcriptional gene regulation, honing his training in molecular biology, next-generation sequencing, and bioinformatics.

Sandra Dienemann

PhD Student

Gottfried Wilhelm Leibniz Universitaet Hannover​

Sandra Dienemann graduated from Leibniz University Hannover (Germany) in 2020 with a bachelor’s degree in Life Science. She further pursued her studies at Hannover Medical School (Germany) and obtained a master’s degree in Biomedicine in 2023 where she gained experience in scaffold-free and hydrogel-based 3D cell culture techniques. Sandra currently works as a research associate and PhD student at the Institute of Technical Chemistry at the Leibniz University Hannover (Germany). Her primary research focuses on the identification of fluorescent metabolites during T cell cultivation and the development of a disposable 2D fluorescence sensor for on-line bioprocess monitoring.

Dr. Ole Wohlenberg

Senior Scientist

Gottfried Wilhelm Leibniz Universitaet Hannover​

Dr. Ole Wohlenberg obtained a Life Science degree from the Leibniz University of Hannover and conducted his PhD at the Institute of Technical Chemistry. His research has been focused on the implementation of Quality by Design principles in biopharmaceutical production processes. He has been working with various cell types and bioreactor systems to determine effects of critical process parameters on process and product quality attributes. Ole Wohlenberg is currently working as a post-doctoral researcher and will be responsible for the cell culture establishment and 2D fluorescence sensor development in Hannover.

Dr Dörte Solle

Project Coordinator

Gottfried Wilhelm Leibniz Universitaet Hannover​

Dr. Dörte Solle studied biology and chemistry and graduated with a PhD at the Institute of Technical Chemistry (TCI) at Leibniz University Hannover (Germany). After a research fellowship at the Fraunhofer Institute for Experimental Medicine in Hannover, she founded her own research group at TCI. Dörte Solle is currently working in the field of mammalian cell culture technology as well as spectroscopy, chemometrics, sensor development and all aspects of process analytical technology (PAT) for bioprocess automation in various scales. Many years of project management of larger interdisciplinary collaborative projects complete her portfolio.

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Prof. Dr. Sascha Beutel

Project Leadership

Gottfried Wilhelm Leibniz Universitaet Hannover​

Prof. Dr. Sascha Beutel studied Chemistry at the Leibniz University of Hannover, where he conducted also his PhD-thesis and finally habilitated in Technical Chemistry. His research works are focussed on bioprocess engineering, the development and optimization of new bioprocesses as well as the development of new technologies for bioprocessing, comprising novel bioreactor construction, process sensor development and digitalization of unit operations. In his research group currently 12 PhD-students conduct their research in third-party funded projects and work on bioprocesses with procaryotes as well as eucaryotic cells.