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From Single Batch to Mass Production–Automated Platform Design Concept for a Phase II Clinical Trial Tissue Engineered Cartilage Product

Advanced Therapy Medicinal Products (ATMP) provide promising treatment options particularly for unmet clinical needs, such as progressive and chronic diseases where currently no satisfying treatment exists. Especially from the ATMP subclass of Tissue Engineered Products (TEPs), only a few have yet b...

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Autores principales: Haeusner, Sebastian, Herbst, Laura, Bittorf, Patrick, Schwarz, Thomas, Henze, Chris, Mauermann, Marc, Ochs, Jelena, Schmitt, Robert, Blache, Ulrich, Wixmerten, Anke, Miot, Sylvie, Martin, Ivan, Pullig, Oliver
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8414576/
https://www.ncbi.nlm.nih.gov/pubmed/34485343
http://dx.doi.org/10.3389/fmed.2021.712917
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author Haeusner, Sebastian
Herbst, Laura
Bittorf, Patrick
Schwarz, Thomas
Henze, Chris
Mauermann, Marc
Ochs, Jelena
Schmitt, Robert
Blache, Ulrich
Wixmerten, Anke
Miot, Sylvie
Martin, Ivan
Pullig, Oliver
author_facet Haeusner, Sebastian
Herbst, Laura
Bittorf, Patrick
Schwarz, Thomas
Henze, Chris
Mauermann, Marc
Ochs, Jelena
Schmitt, Robert
Blache, Ulrich
Wixmerten, Anke
Miot, Sylvie
Martin, Ivan
Pullig, Oliver
author_sort Haeusner, Sebastian
collection PubMed
description Advanced Therapy Medicinal Products (ATMP) provide promising treatment options particularly for unmet clinical needs, such as progressive and chronic diseases where currently no satisfying treatment exists. Especially from the ATMP subclass of Tissue Engineered Products (TEPs), only a few have yet been translated from an academic setting to clinic and beyond. A reason for low numbers of TEPs in current clinical trials and one main key hurdle for TEPs is the cost and labor-intensive manufacturing process. Manual production steps require experienced personnel, are challenging to standardize and to scale up. Automated manufacturing has the potential to overcome these challenges, toward an increasing cost-effectiveness. One major obstacle for automation is the control and risk prevention of cross contaminations, especially when handling parallel production lines of different patient material. These critical steps necessitate validated effective and efficient cleaning procedures in an automated system. In this perspective, possible technologies, concepts and solutions to existing ATMP manufacturing hurdles are discussed on the example of a late clinical phase II trial TEP. In compliance to Good Manufacturing Practice (GMP) guidelines, we propose a dual arm robot based isolator approach. Our novel concept enables complete process automation for adherent cell culture, and the translation of all manual process steps with standard laboratory equipment. Moreover, we discuss novel solutions for automated cleaning, without the need for human intervention. Consequently, our automation concept offers the unique chance to scale up production while becoming more cost-effective, which will ultimately increase TEP availability to a broader number of patients.
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spelling pubmed-84145762021-09-04 From Single Batch to Mass Production–Automated Platform Design Concept for a Phase II Clinical Trial Tissue Engineered Cartilage Product Haeusner, Sebastian Herbst, Laura Bittorf, Patrick Schwarz, Thomas Henze, Chris Mauermann, Marc Ochs, Jelena Schmitt, Robert Blache, Ulrich Wixmerten, Anke Miot, Sylvie Martin, Ivan Pullig, Oliver Front Med (Lausanne) Medicine Advanced Therapy Medicinal Products (ATMP) provide promising treatment options particularly for unmet clinical needs, such as progressive and chronic diseases where currently no satisfying treatment exists. Especially from the ATMP subclass of Tissue Engineered Products (TEPs), only a few have yet been translated from an academic setting to clinic and beyond. A reason for low numbers of TEPs in current clinical trials and one main key hurdle for TEPs is the cost and labor-intensive manufacturing process. Manual production steps require experienced personnel, are challenging to standardize and to scale up. Automated manufacturing has the potential to overcome these challenges, toward an increasing cost-effectiveness. One major obstacle for automation is the control and risk prevention of cross contaminations, especially when handling parallel production lines of different patient material. These critical steps necessitate validated effective and efficient cleaning procedures in an automated system. In this perspective, possible technologies, concepts and solutions to existing ATMP manufacturing hurdles are discussed on the example of a late clinical phase II trial TEP. In compliance to Good Manufacturing Practice (GMP) guidelines, we propose a dual arm robot based isolator approach. Our novel concept enables complete process automation for adherent cell culture, and the translation of all manual process steps with standard laboratory equipment. Moreover, we discuss novel solutions for automated cleaning, without the need for human intervention. Consequently, our automation concept offers the unique chance to scale up production while becoming more cost-effective, which will ultimately increase TEP availability to a broader number of patients. Frontiers Media S.A. 2021-08-13 /pmc/articles/PMC8414576/ /pubmed/34485343 http://dx.doi.org/10.3389/fmed.2021.712917 Text en Copyright © 2021 Haeusner, Herbst, Bittorf, Schwarz, Henze, Mauermann, Ochs, Schmitt, Blache, Wixmerten, Miot, Martin and Pullig. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Medicine
Haeusner, Sebastian
Herbst, Laura
Bittorf, Patrick
Schwarz, Thomas
Henze, Chris
Mauermann, Marc
Ochs, Jelena
Schmitt, Robert
Blache, Ulrich
Wixmerten, Anke
Miot, Sylvie
Martin, Ivan
Pullig, Oliver
From Single Batch to Mass Production–Automated Platform Design Concept for a Phase II Clinical Trial Tissue Engineered Cartilage Product
title From Single Batch to Mass Production–Automated Platform Design Concept for a Phase II Clinical Trial Tissue Engineered Cartilage Product
title_full From Single Batch to Mass Production–Automated Platform Design Concept for a Phase II Clinical Trial Tissue Engineered Cartilage Product
title_fullStr From Single Batch to Mass Production–Automated Platform Design Concept for a Phase II Clinical Trial Tissue Engineered Cartilage Product
title_full_unstemmed From Single Batch to Mass Production–Automated Platform Design Concept for a Phase II Clinical Trial Tissue Engineered Cartilage Product
title_short From Single Batch to Mass Production–Automated Platform Design Concept for a Phase II Clinical Trial Tissue Engineered Cartilage Product
title_sort from single batch to mass production–automated platform design concept for a phase ii clinical trial tissue engineered cartilage product
topic Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8414576/
https://www.ncbi.nlm.nih.gov/pubmed/34485343
http://dx.doi.org/10.3389/fmed.2021.712917
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