Toward Rapid, Widely Available Autologous CAR-T Cell Therapy – Artificial Intelligence and Automation Enabling the Smart Manufacturing Hospital

CAR-T cell therapy is a promising treatment for acute leukemia and lymphoma. CAR-T cell therapies take a pioneering role in autologous gene therapy with three EMA-approved products. However, the chance of clinical success remains relatively low as the applicability of CAR-T cell therapy suffers from...

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Main Authors: Simon Hort, Laura Herbst, Niklas Bäckel, Frederik Erkens, Bastian Niessing, Maik Frye, Niels König, Ioannis Papantoniou, Michael Hudecek, John J. L. Jacobs, Robert H. Schmitt
Format: Article
Language:English
Published: Frontiers Media S.A. 2022-06-01
Series:Frontiers in Medicine
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2022.913287/full
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author Simon Hort
Laura Herbst
Niklas Bäckel
Frederik Erkens
Bastian Niessing
Maik Frye
Niels König
Ioannis Papantoniou
Ioannis Papantoniou
Ioannis Papantoniou
Michael Hudecek
John J. L. Jacobs
Robert H. Schmitt
Robert H. Schmitt
author_facet Simon Hort
Laura Herbst
Niklas Bäckel
Frederik Erkens
Bastian Niessing
Maik Frye
Niels König
Ioannis Papantoniou
Ioannis Papantoniou
Ioannis Papantoniou
Michael Hudecek
John J. L. Jacobs
Robert H. Schmitt
Robert H. Schmitt
author_sort Simon Hort
collection DOAJ
description CAR-T cell therapy is a promising treatment for acute leukemia and lymphoma. CAR-T cell therapies take a pioneering role in autologous gene therapy with three EMA-approved products. However, the chance of clinical success remains relatively low as the applicability of CAR-T cell therapy suffers from long, labor-intensive manufacturing and a lack of comprehensive insight into the bioprocess. This leads to high manufacturing costs and limited clinical success, preventing the widespread use of CAR-T cell therapies. New manufacturing approaches are needed to lower costs to improve manufacturing capacity and shorten provision times. Semi-automated devices such as the Miltenyi Prodigy® were developed to reduce hands-on production time. However, these devices are not equipped with the process analytical technology necessary to fully characterize and control the process. An automated AI-driven CAR-T cell manufacturing platform in smart manufacturing hospitals (SMH) is being developed to address these challenges. Automation will increase the cost-effectiveness and robustness of manufacturing. Using Artificial Intelligence (AI) to interpret the data collected on the platform will provide valuable process insights and drive decisions for process optimization. The smart integration of automated CAR-T cell manufacturing platforms into hospitals enables the independent manufacture of autologous CAR-T cell products. In this perspective, we will be discussing current challenges and opportunities of the patient-specific but highly automated, AI-enabled CAR-T cell manufacturing. A first automation concept will be shown, including a system architecture based on current Industry 4.0 approaches for AI integration.
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spelling doaj.art-9bb8ea8db6534f5982f371b47e1dbc022022-12-22T03:29:43ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2022-06-01910.3389/fmed.2022.913287913287Toward Rapid, Widely Available Autologous CAR-T Cell Therapy – Artificial Intelligence and Automation Enabling the Smart Manufacturing HospitalSimon Hort0Laura Herbst1Niklas Bäckel2Frederik Erkens3Bastian Niessing4Maik Frye5Niels König6Ioannis Papantoniou7Ioannis Papantoniou8Ioannis Papantoniou9Michael Hudecek10John J. L. Jacobs11Robert H. Schmitt12Robert H. Schmitt13Fraunhofer Institute for Production Technology IPT, Aachen, GermanyFraunhofer Institute for Production Technology IPT, Aachen, GermanyFraunhofer Institute for Production Technology IPT, Aachen, GermanyFraunhofer Institute for Production Technology IPT, Aachen, GermanyFraunhofer Institute for Production Technology IPT, Aachen, GermanyFraunhofer Institute for Production Technology IPT, Aachen, GermanyFraunhofer Institute for Production Technology IPT, Aachen, GermanyInstitute of Chemical Engineering Sciences, Foundation for Research and Technology-Greece (FORTH), Patras, GreeceSkeletal Biology and Engineering Research Centre, Department of Development and Regeneration, KU Leuven, Leuven, BelgiumPrometheus the Leuven R&D Translational Division of Skeletal Tissue Engineering, KU Leuven, Leuven, BelgiumLehrstuhl für Zelluläre Immuntherapie, Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, GermanyORTEC BV, Zoetermeer, NetherlandsFraunhofer Institute for Production Technology IPT, Aachen, GermanyLaboratory for Machine Tools and Production Engineering (WZL) of RWTH Aachen University, Aachen, GermanyCAR-T cell therapy is a promising treatment for acute leukemia and lymphoma. CAR-T cell therapies take a pioneering role in autologous gene therapy with three EMA-approved products. However, the chance of clinical success remains relatively low as the applicability of CAR-T cell therapy suffers from long, labor-intensive manufacturing and a lack of comprehensive insight into the bioprocess. This leads to high manufacturing costs and limited clinical success, preventing the widespread use of CAR-T cell therapies. New manufacturing approaches are needed to lower costs to improve manufacturing capacity and shorten provision times. Semi-automated devices such as the Miltenyi Prodigy® were developed to reduce hands-on production time. However, these devices are not equipped with the process analytical technology necessary to fully characterize and control the process. An automated AI-driven CAR-T cell manufacturing platform in smart manufacturing hospitals (SMH) is being developed to address these challenges. Automation will increase the cost-effectiveness and robustness of manufacturing. Using Artificial Intelligence (AI) to interpret the data collected on the platform will provide valuable process insights and drive decisions for process optimization. The smart integration of automated CAR-T cell manufacturing platforms into hospitals enables the independent manufacture of autologous CAR-T cell products. In this perspective, we will be discussing current challenges and opportunities of the patient-specific but highly automated, AI-enabled CAR-T cell manufacturing. A first automation concept will be shown, including a system architecture based on current Industry 4.0 approaches for AI integration.https://www.frontiersin.org/articles/10.3389/fmed.2022.913287/fullATMPCAR-T cellartificial intelligenceautomationautologousmanufacturing
spellingShingle Simon Hort
Laura Herbst
Niklas Bäckel
Frederik Erkens
Bastian Niessing
Maik Frye
Niels König
Ioannis Papantoniou
Ioannis Papantoniou
Ioannis Papantoniou
Michael Hudecek
John J. L. Jacobs
Robert H. Schmitt
Robert H. Schmitt
Toward Rapid, Widely Available Autologous CAR-T Cell Therapy – Artificial Intelligence and Automation Enabling the Smart Manufacturing Hospital
Frontiers in Medicine
ATMP
CAR-T cell
artificial intelligence
automation
autologous
manufacturing
title Toward Rapid, Widely Available Autologous CAR-T Cell Therapy – Artificial Intelligence and Automation Enabling the Smart Manufacturing Hospital
title_full Toward Rapid, Widely Available Autologous CAR-T Cell Therapy – Artificial Intelligence and Automation Enabling the Smart Manufacturing Hospital
title_fullStr Toward Rapid, Widely Available Autologous CAR-T Cell Therapy – Artificial Intelligence and Automation Enabling the Smart Manufacturing Hospital
title_full_unstemmed Toward Rapid, Widely Available Autologous CAR-T Cell Therapy – Artificial Intelligence and Automation Enabling the Smart Manufacturing Hospital
title_short Toward Rapid, Widely Available Autologous CAR-T Cell Therapy – Artificial Intelligence and Automation Enabling the Smart Manufacturing Hospital
title_sort toward rapid widely available autologous car t cell therapy artificial intelligence and automation enabling the smart manufacturing hospital
topic ATMP
CAR-T cell
artificial intelligence
automation
autologous
manufacturing
url https://www.frontiersin.org/articles/10.3389/fmed.2022.913287/full
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