Distributed automated manufacturing of pluripotent stem cell products
Abstract Establishing how to effectively manufacture cell therapies is an industry-level problem. Decentralised manufacturing is of increasing importance, and its challenges are recognised by healthcare regulators with deviations and comparability issues receiving specific attention from them. This...
Ausführliche Beschreibung
Autor*in: |
Shariatzadeh, Maryam [verfasserIn] |
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Format: |
Artikel |
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Sprache: |
Englisch |
Erschienen: |
2019 |
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Anmerkung: |
© The Author(s) 2019 |
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Übergeordnetes Werk: |
Enthalten in: The international journal of advanced manufacturing technology - Springer London, 1985, 106(2019), 3-4 vom: 04. Dez., Seite 1085-1103 |
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Übergeordnetes Werk: |
volume:106 ; year:2019 ; number:3-4 ; day:04 ; month:12 ; pages:1085-1103 |
Links: |
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DOI / URN: |
10.1007/s00170-019-04516-1 |
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Katalog-ID: |
OLC2026150052 |
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520 | |a Abstract Establishing how to effectively manufacture cell therapies is an industry-level problem. Decentralised manufacturing is of increasing importance, and its challenges are recognised by healthcare regulators with deviations and comparability issues receiving specific attention from them. This paper is the first to report the deviations and other risks encountered when implementing the expansion of human pluripotent stem cells (hPSCs) in an automated three international site–decentralised manufacturing setting. An experimental demonstrator project expanded a human embryonal carcinoma cell line (2102Ep) at three development sites in France, Germany and the UK using the CompacT SelecT (Sartorius Stedim, Royston, UK) automated cell culture platform. Anticipated variations between sites spanned material input, features of the process itself and production system details including different quality management systems and personnel. Where possible, these were pre-addressed by implementing strategies including standardisation, cell bank mycoplasma testing and specific engineering and process improvements. However, despite such measures, unexpected deviations occurred between sites including software incompatibility and machine/process errors together with uncharacteristic contaminations. Many only became apparent during process proving or during the process run. Further, parameters including growth rate and viability discrepancies could only be determined post-run, preventing ‘live’ corrective measures. The work confirms the critical nature of approaches usually taken in Good Manufacturing Practice (GMP) manufacturing settings and especially emphasises the requirement for monitoring steps to be included within the production system. Real-time process monitoring coupled with carefully structured quality systems is essential for multiple site working including clarity of decision-making roles. Additionally, an over-reliance upon post-process visual microscopic comparisons has major limitations; it is difficult for non-experts to detect deleterious culture changes and such detection is slow. | ||
650 | 4 | |a Cell therapies | |
650 | 4 | |a Comparability | |
650 | 4 | |a Low-grade infection | |
650 | 4 | |a Mitigation strategies | |
650 | 4 | |a Monitoring | |
650 | 4 | |a Process deviation | |
700 | 1 | |a Chandra, Amit |4 aut | |
700 | 1 | |a Wilson, Samantha L |4 aut | |
700 | 1 | |a McCall, Mark J |4 aut | |
700 | 1 | |a Morizur, Lise |4 aut | |
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10.1007/s00170-019-04516-1 doi (DE-627)OLC2026150052 (DE-He213)s00170-019-04516-1-p DE-627 ger DE-627 rakwb eng 670 VZ Shariatzadeh, Maryam verfasserin aut Distributed automated manufacturing of pluripotent stem cell products 2019 Text txt rdacontent ohne Hilfsmittel zu benutzen n rdamedia Band nc rdacarrier © The Author(s) 2019 Abstract Establishing how to effectively manufacture cell therapies is an industry-level problem. Decentralised manufacturing is of increasing importance, and its challenges are recognised by healthcare regulators with deviations and comparability issues receiving specific attention from them. This paper is the first to report the deviations and other risks encountered when implementing the expansion of human pluripotent stem cells (hPSCs) in an automated three international site–decentralised manufacturing setting. An experimental demonstrator project expanded a human embryonal carcinoma cell line (2102Ep) at three development sites in France, Germany and the UK using the CompacT SelecT (Sartorius Stedim, Royston, UK) automated cell culture platform. Anticipated variations between sites spanned material input, features of the process itself and production system details including different quality management systems and personnel. Where possible, these were pre-addressed by implementing strategies including standardisation, cell bank mycoplasma testing and specific engineering and process improvements. However, despite such measures, unexpected deviations occurred between sites including software incompatibility and machine/process errors together with uncharacteristic contaminations. Many only became apparent during process proving or during the process run. Further, parameters including growth rate and viability discrepancies could only be determined post-run, preventing ‘live’ corrective measures. The work confirms the critical nature of approaches usually taken in Good Manufacturing Practice (GMP) manufacturing settings and especially emphasises the requirement for monitoring steps to be included within the production system. Real-time process monitoring coupled with carefully structured quality systems is essential for multiple site working including clarity of decision-making roles. Additionally, an over-reliance upon post-process visual microscopic comparisons has major limitations; it is difficult for non-experts to detect deleterious culture changes and such detection is slow. Cell therapies Comparability Low-grade infection Mitigation strategies Monitoring Process deviation Chandra, Amit aut Wilson, Samantha L aut McCall, Mark J aut Morizur, Lise aut Lesueur, Léa aut Chose, Olivier aut Gepp, Michael M. aut Schulz, André aut Neubauer, Julia C. aut Zimmermann, Heiko aut Abranches, Elsa aut Man, Jennifer aut O’Shea, Orla aut Stacey, Glyn aut Hewitt, Zoe aut Williams, David J (orcid)0000-0002-4943-8543 aut Enthalten in The international journal of advanced manufacturing technology Springer London, 1985 106(2019), 3-4 vom: 04. Dez., Seite 1085-1103 (DE-627)129185299 (DE-600)52651-4 (DE-576)014456192 0268-3768 nnns volume:106 year:2019 number:3-4 day:04 month:12 pages:1085-1103 https://doi.org/10.1007/s00170-019-04516-1 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_OLC SSG-OLC-TEC SSG-OLC-PHA SSG-OLC-DE-84 GBV_ILN_70 GBV_ILN_2018 GBV_ILN_2333 AR 106 2019 3-4 04 12 1085-1103 |
spelling |
10.1007/s00170-019-04516-1 doi (DE-627)OLC2026150052 (DE-He213)s00170-019-04516-1-p DE-627 ger DE-627 rakwb eng 670 VZ Shariatzadeh, Maryam verfasserin aut Distributed automated manufacturing of pluripotent stem cell products 2019 Text txt rdacontent ohne Hilfsmittel zu benutzen n rdamedia Band nc rdacarrier © The Author(s) 2019 Abstract Establishing how to effectively manufacture cell therapies is an industry-level problem. Decentralised manufacturing is of increasing importance, and its challenges are recognised by healthcare regulators with deviations and comparability issues receiving specific attention from them. This paper is the first to report the deviations and other risks encountered when implementing the expansion of human pluripotent stem cells (hPSCs) in an automated three international site–decentralised manufacturing setting. An experimental demonstrator project expanded a human embryonal carcinoma cell line (2102Ep) at three development sites in France, Germany and the UK using the CompacT SelecT (Sartorius Stedim, Royston, UK) automated cell culture platform. Anticipated variations between sites spanned material input, features of the process itself and production system details including different quality management systems and personnel. Where possible, these were pre-addressed by implementing strategies including standardisation, cell bank mycoplasma testing and specific engineering and process improvements. However, despite such measures, unexpected deviations occurred between sites including software incompatibility and machine/process errors together with uncharacteristic contaminations. Many only became apparent during process proving or during the process run. Further, parameters including growth rate and viability discrepancies could only be determined post-run, preventing ‘live’ corrective measures. The work confirms the critical nature of approaches usually taken in Good Manufacturing Practice (GMP) manufacturing settings and especially emphasises the requirement for monitoring steps to be included within the production system. Real-time process monitoring coupled with carefully structured quality systems is essential for multiple site working including clarity of decision-making roles. Additionally, an over-reliance upon post-process visual microscopic comparisons has major limitations; it is difficult for non-experts to detect deleterious culture changes and such detection is slow. Cell therapies Comparability Low-grade infection Mitigation strategies Monitoring Process deviation Chandra, Amit aut Wilson, Samantha L aut McCall, Mark J aut Morizur, Lise aut Lesueur, Léa aut Chose, Olivier aut Gepp, Michael M. aut Schulz, André aut Neubauer, Julia C. aut Zimmermann, Heiko aut Abranches, Elsa aut Man, Jennifer aut O’Shea, Orla aut Stacey, Glyn aut Hewitt, Zoe aut Williams, David J (orcid)0000-0002-4943-8543 aut Enthalten in The international journal of advanced manufacturing technology Springer London, 1985 106(2019), 3-4 vom: 04. Dez., Seite 1085-1103 (DE-627)129185299 (DE-600)52651-4 (DE-576)014456192 0268-3768 nnns volume:106 year:2019 number:3-4 day:04 month:12 pages:1085-1103 https://doi.org/10.1007/s00170-019-04516-1 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_OLC SSG-OLC-TEC SSG-OLC-PHA SSG-OLC-DE-84 GBV_ILN_70 GBV_ILN_2018 GBV_ILN_2333 AR 106 2019 3-4 04 12 1085-1103 |
allfields_unstemmed |
10.1007/s00170-019-04516-1 doi (DE-627)OLC2026150052 (DE-He213)s00170-019-04516-1-p DE-627 ger DE-627 rakwb eng 670 VZ Shariatzadeh, Maryam verfasserin aut Distributed automated manufacturing of pluripotent stem cell products 2019 Text txt rdacontent ohne Hilfsmittel zu benutzen n rdamedia Band nc rdacarrier © The Author(s) 2019 Abstract Establishing how to effectively manufacture cell therapies is an industry-level problem. Decentralised manufacturing is of increasing importance, and its challenges are recognised by healthcare regulators with deviations and comparability issues receiving specific attention from them. This paper is the first to report the deviations and other risks encountered when implementing the expansion of human pluripotent stem cells (hPSCs) in an automated three international site–decentralised manufacturing setting. An experimental demonstrator project expanded a human embryonal carcinoma cell line (2102Ep) at three development sites in France, Germany and the UK using the CompacT SelecT (Sartorius Stedim, Royston, UK) automated cell culture platform. Anticipated variations between sites spanned material input, features of the process itself and production system details including different quality management systems and personnel. Where possible, these were pre-addressed by implementing strategies including standardisation, cell bank mycoplasma testing and specific engineering and process improvements. However, despite such measures, unexpected deviations occurred between sites including software incompatibility and machine/process errors together with uncharacteristic contaminations. Many only became apparent during process proving or during the process run. Further, parameters including growth rate and viability discrepancies could only be determined post-run, preventing ‘live’ corrective measures. The work confirms the critical nature of approaches usually taken in Good Manufacturing Practice (GMP) manufacturing settings and especially emphasises the requirement for monitoring steps to be included within the production system. Real-time process monitoring coupled with carefully structured quality systems is essential for multiple site working including clarity of decision-making roles. Additionally, an over-reliance upon post-process visual microscopic comparisons has major limitations; it is difficult for non-experts to detect deleterious culture changes and such detection is slow. Cell therapies Comparability Low-grade infection Mitigation strategies Monitoring Process deviation Chandra, Amit aut Wilson, Samantha L aut McCall, Mark J aut Morizur, Lise aut Lesueur, Léa aut Chose, Olivier aut Gepp, Michael M. aut Schulz, André aut Neubauer, Julia C. aut Zimmermann, Heiko aut Abranches, Elsa aut Man, Jennifer aut O’Shea, Orla aut Stacey, Glyn aut Hewitt, Zoe aut Williams, David J (orcid)0000-0002-4943-8543 aut Enthalten in The international journal of advanced manufacturing technology Springer London, 1985 106(2019), 3-4 vom: 04. Dez., Seite 1085-1103 (DE-627)129185299 (DE-600)52651-4 (DE-576)014456192 0268-3768 nnns volume:106 year:2019 number:3-4 day:04 month:12 pages:1085-1103 https://doi.org/10.1007/s00170-019-04516-1 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_OLC SSG-OLC-TEC SSG-OLC-PHA SSG-OLC-DE-84 GBV_ILN_70 GBV_ILN_2018 GBV_ILN_2333 AR 106 2019 3-4 04 12 1085-1103 |
allfieldsGer |
10.1007/s00170-019-04516-1 doi (DE-627)OLC2026150052 (DE-He213)s00170-019-04516-1-p DE-627 ger DE-627 rakwb eng 670 VZ Shariatzadeh, Maryam verfasserin aut Distributed automated manufacturing of pluripotent stem cell products 2019 Text txt rdacontent ohne Hilfsmittel zu benutzen n rdamedia Band nc rdacarrier © The Author(s) 2019 Abstract Establishing how to effectively manufacture cell therapies is an industry-level problem. Decentralised manufacturing is of increasing importance, and its challenges are recognised by healthcare regulators with deviations and comparability issues receiving specific attention from them. This paper is the first to report the deviations and other risks encountered when implementing the expansion of human pluripotent stem cells (hPSCs) in an automated three international site–decentralised manufacturing setting. An experimental demonstrator project expanded a human embryonal carcinoma cell line (2102Ep) at three development sites in France, Germany and the UK using the CompacT SelecT (Sartorius Stedim, Royston, UK) automated cell culture platform. Anticipated variations between sites spanned material input, features of the process itself and production system details including different quality management systems and personnel. Where possible, these were pre-addressed by implementing strategies including standardisation, cell bank mycoplasma testing and specific engineering and process improvements. However, despite such measures, unexpected deviations occurred between sites including software incompatibility and machine/process errors together with uncharacteristic contaminations. Many only became apparent during process proving or during the process run. Further, parameters including growth rate and viability discrepancies could only be determined post-run, preventing ‘live’ corrective measures. The work confirms the critical nature of approaches usually taken in Good Manufacturing Practice (GMP) manufacturing settings and especially emphasises the requirement for monitoring steps to be included within the production system. Real-time process monitoring coupled with carefully structured quality systems is essential for multiple site working including clarity of decision-making roles. Additionally, an over-reliance upon post-process visual microscopic comparisons has major limitations; it is difficult for non-experts to detect deleterious culture changes and such detection is slow. Cell therapies Comparability Low-grade infection Mitigation strategies Monitoring Process deviation Chandra, Amit aut Wilson, Samantha L aut McCall, Mark J aut Morizur, Lise aut Lesueur, Léa aut Chose, Olivier aut Gepp, Michael M. aut Schulz, André aut Neubauer, Julia C. aut Zimmermann, Heiko aut Abranches, Elsa aut Man, Jennifer aut O’Shea, Orla aut Stacey, Glyn aut Hewitt, Zoe aut Williams, David J (orcid)0000-0002-4943-8543 aut Enthalten in The international journal of advanced manufacturing technology Springer London, 1985 106(2019), 3-4 vom: 04. Dez., Seite 1085-1103 (DE-627)129185299 (DE-600)52651-4 (DE-576)014456192 0268-3768 nnns volume:106 year:2019 number:3-4 day:04 month:12 pages:1085-1103 https://doi.org/10.1007/s00170-019-04516-1 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_OLC SSG-OLC-TEC SSG-OLC-PHA SSG-OLC-DE-84 GBV_ILN_70 GBV_ILN_2018 GBV_ILN_2333 AR 106 2019 3-4 04 12 1085-1103 |
allfieldsSound |
10.1007/s00170-019-04516-1 doi (DE-627)OLC2026150052 (DE-He213)s00170-019-04516-1-p DE-627 ger DE-627 rakwb eng 670 VZ Shariatzadeh, Maryam verfasserin aut Distributed automated manufacturing of pluripotent stem cell products 2019 Text txt rdacontent ohne Hilfsmittel zu benutzen n rdamedia Band nc rdacarrier © The Author(s) 2019 Abstract Establishing how to effectively manufacture cell therapies is an industry-level problem. Decentralised manufacturing is of increasing importance, and its challenges are recognised by healthcare regulators with deviations and comparability issues receiving specific attention from them. This paper is the first to report the deviations and other risks encountered when implementing the expansion of human pluripotent stem cells (hPSCs) in an automated three international site–decentralised manufacturing setting. An experimental demonstrator project expanded a human embryonal carcinoma cell line (2102Ep) at three development sites in France, Germany and the UK using the CompacT SelecT (Sartorius Stedim, Royston, UK) automated cell culture platform. Anticipated variations between sites spanned material input, features of the process itself and production system details including different quality management systems and personnel. Where possible, these were pre-addressed by implementing strategies including standardisation, cell bank mycoplasma testing and specific engineering and process improvements. However, despite such measures, unexpected deviations occurred between sites including software incompatibility and machine/process errors together with uncharacteristic contaminations. Many only became apparent during process proving or during the process run. Further, parameters including growth rate and viability discrepancies could only be determined post-run, preventing ‘live’ corrective measures. The work confirms the critical nature of approaches usually taken in Good Manufacturing Practice (GMP) manufacturing settings and especially emphasises the requirement for monitoring steps to be included within the production system. Real-time process monitoring coupled with carefully structured quality systems is essential for multiple site working including clarity of decision-making roles. Additionally, an over-reliance upon post-process visual microscopic comparisons has major limitations; it is difficult for non-experts to detect deleterious culture changes and such detection is slow. Cell therapies Comparability Low-grade infection Mitigation strategies Monitoring Process deviation Chandra, Amit aut Wilson, Samantha L aut McCall, Mark J aut Morizur, Lise aut Lesueur, Léa aut Chose, Olivier aut Gepp, Michael M. aut Schulz, André aut Neubauer, Julia C. aut Zimmermann, Heiko aut Abranches, Elsa aut Man, Jennifer aut O’Shea, Orla aut Stacey, Glyn aut Hewitt, Zoe aut Williams, David J (orcid)0000-0002-4943-8543 aut Enthalten in The international journal of advanced manufacturing technology Springer London, 1985 106(2019), 3-4 vom: 04. Dez., Seite 1085-1103 (DE-627)129185299 (DE-600)52651-4 (DE-576)014456192 0268-3768 nnns volume:106 year:2019 number:3-4 day:04 month:12 pages:1085-1103 https://doi.org/10.1007/s00170-019-04516-1 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_OLC SSG-OLC-TEC SSG-OLC-PHA SSG-OLC-DE-84 GBV_ILN_70 GBV_ILN_2018 GBV_ILN_2333 AR 106 2019 3-4 04 12 1085-1103 |
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Shariatzadeh, Maryam Chandra, Amit Wilson, Samantha L McCall, Mark J Morizur, Lise Lesueur, Léa Chose, Olivier Gepp, Michael M. Schulz, André Neubauer, Julia C. Zimmermann, Heiko Abranches, Elsa Man, Jennifer O’Shea, Orla Stacey, Glyn Hewitt, Zoe Williams, David J |
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Abstract Establishing how to effectively manufacture cell therapies is an industry-level problem. Decentralised manufacturing is of increasing importance, and its challenges are recognised by healthcare regulators with deviations and comparability issues receiving specific attention from them. This paper is the first to report the deviations and other risks encountered when implementing the expansion of human pluripotent stem cells (hPSCs) in an automated three international site–decentralised manufacturing setting. An experimental demonstrator project expanded a human embryonal carcinoma cell line (2102Ep) at three development sites in France, Germany and the UK using the CompacT SelecT (Sartorius Stedim, Royston, UK) automated cell culture platform. Anticipated variations between sites spanned material input, features of the process itself and production system details including different quality management systems and personnel. Where possible, these were pre-addressed by implementing strategies including standardisation, cell bank mycoplasma testing and specific engineering and process improvements. However, despite such measures, unexpected deviations occurred between sites including software incompatibility and machine/process errors together with uncharacteristic contaminations. Many only became apparent during process proving or during the process run. Further, parameters including growth rate and viability discrepancies could only be determined post-run, preventing ‘live’ corrective measures. The work confirms the critical nature of approaches usually taken in Good Manufacturing Practice (GMP) manufacturing settings and especially emphasises the requirement for monitoring steps to be included within the production system. Real-time process monitoring coupled with carefully structured quality systems is essential for multiple site working including clarity of decision-making roles. Additionally, an over-reliance upon post-process visual microscopic comparisons has major limitations; it is difficult for non-experts to detect deleterious culture changes and such detection is slow. © The Author(s) 2019 |
abstractGer |
Abstract Establishing how to effectively manufacture cell therapies is an industry-level problem. Decentralised manufacturing is of increasing importance, and its challenges are recognised by healthcare regulators with deviations and comparability issues receiving specific attention from them. This paper is the first to report the deviations and other risks encountered when implementing the expansion of human pluripotent stem cells (hPSCs) in an automated three international site–decentralised manufacturing setting. An experimental demonstrator project expanded a human embryonal carcinoma cell line (2102Ep) at three development sites in France, Germany and the UK using the CompacT SelecT (Sartorius Stedim, Royston, UK) automated cell culture platform. Anticipated variations between sites spanned material input, features of the process itself and production system details including different quality management systems and personnel. Where possible, these were pre-addressed by implementing strategies including standardisation, cell bank mycoplasma testing and specific engineering and process improvements. However, despite such measures, unexpected deviations occurred between sites including software incompatibility and machine/process errors together with uncharacteristic contaminations. Many only became apparent during process proving or during the process run. Further, parameters including growth rate and viability discrepancies could only be determined post-run, preventing ‘live’ corrective measures. The work confirms the critical nature of approaches usually taken in Good Manufacturing Practice (GMP) manufacturing settings and especially emphasises the requirement for monitoring steps to be included within the production system. Real-time process monitoring coupled with carefully structured quality systems is essential for multiple site working including clarity of decision-making roles. Additionally, an over-reliance upon post-process visual microscopic comparisons has major limitations; it is difficult for non-experts to detect deleterious culture changes and such detection is slow. © The Author(s) 2019 |
abstract_unstemmed |
Abstract Establishing how to effectively manufacture cell therapies is an industry-level problem. Decentralised manufacturing is of increasing importance, and its challenges are recognised by healthcare regulators with deviations and comparability issues receiving specific attention from them. This paper is the first to report the deviations and other risks encountered when implementing the expansion of human pluripotent stem cells (hPSCs) in an automated three international site–decentralised manufacturing setting. An experimental demonstrator project expanded a human embryonal carcinoma cell line (2102Ep) at three development sites in France, Germany and the UK using the CompacT SelecT (Sartorius Stedim, Royston, UK) automated cell culture platform. Anticipated variations between sites spanned material input, features of the process itself and production system details including different quality management systems and personnel. Where possible, these were pre-addressed by implementing strategies including standardisation, cell bank mycoplasma testing and specific engineering and process improvements. However, despite such measures, unexpected deviations occurred between sites including software incompatibility and machine/process errors together with uncharacteristic contaminations. Many only became apparent during process proving or during the process run. Further, parameters including growth rate and viability discrepancies could only be determined post-run, preventing ‘live’ corrective measures. The work confirms the critical nature of approaches usually taken in Good Manufacturing Practice (GMP) manufacturing settings and especially emphasises the requirement for monitoring steps to be included within the production system. Real-time process monitoring coupled with carefully structured quality systems is essential for multiple site working including clarity of decision-making roles. Additionally, an over-reliance upon post-process visual microscopic comparisons has major limitations; it is difficult for non-experts to detect deleterious culture changes and such detection is slow. © The Author(s) 2019 |
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