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Modular and reconfigurable factories for continuous production innovation in pharmaceutical manufacturing.

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Title: Modular and reconfigurable factories for continuous production innovation in pharmaceutical manufacturing.
Authors: Schwörer, Tristan1 (AUTHOR) tristans@mp.aau.dk, Jensen, Martin Bieber1 (AUTHOR), Schou, Casper1 (AUTHOR), Dueholm, Bjørn Christian1 (AUTHOR), Andersen, Rasmus1 (AUTHOR), de Neergaard, William2 (AUTHOR), Chrysostomou, Dimitrios1 (AUTHOR), Madsen, Ole1 (AUTHOR), Olesen, Oline Vinter3 (AUTHOR)
Source: International Journal of Production Research. Mar2026, Vol. 64 Issue 6, p2210-2232. 23p.
Subjects: Flexible manufacturing systems, Continuous processing, Pharmaceutical chemicals manufacturing, Quality assurance standards, Aseptic packaging, Production engineering, Protein drugs
Abstract: Biologically-based drugs can target a broader range of diseases with increased precision than traditional synthesised drugs, enabling the targeting of rare diseases. This shift impacts production systems, as batch sizes decrease and portfolio diversity increases. While initiatives exist to revolutionise production systems using state-of-the-art technologies, they often overlook the full life cycle of production systems holistically, including design, reconfiguration, and scaling. This paper outlines the pharmaceutical industry's need for purpose-built production systems that are fast to develop and modify. It proposes splitting traditional production systems into an aseptic production innovation factory and derived Good-Manufacturing-Practise-compliant aseptic production factories, both relying on a highly modular, changeable architecture. The proposed conceptual architecture is exemplified on various use cases, highlighting how it accelerates new products and technology introduction, supports employee training, and accelerates validation compared to conventional approaches. This is achieved by transitioning from digital design and simulation through the aseptic production innovation factory into validated aseptic production factories. While the architecture addresses key challenges of current pharmaceutical production systems, it is not without risk. Companies must take ownership of this architecture, especially its digital viewpoint, and rely on collaborations and co-development with technology providers to achieve modularity and reconfigurability across all structural levels. [ABSTRACT FROM AUTHOR]
Copyright of International Journal of Production Research is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Modular and reconfigurable factories for continuous production innovation in pharmaceutical manufacturing.
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  Data: <searchLink fieldCode="AR" term="%22Schwörer%2C+Tristan%22">Schwörer, Tristan</searchLink><relatesTo>1</relatesTo> (AUTHOR)<i> tristans@mp.aau.dk</i><br /><searchLink fieldCode="AR" term="%22Jensen%2C+Martin+Bieber%22">Jensen, Martin Bieber</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Schou%2C+Casper%22">Schou, Casper</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Dueholm%2C+Bjørn+Christian%22">Dueholm, Bjørn Christian</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Andersen%2C+Rasmus%22">Andersen, Rasmus</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22de+Neergaard%2C+William%22">de Neergaard, William</searchLink><relatesTo>2</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Chrysostomou%2C+Dimitrios%22">Chrysostomou, Dimitrios</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Madsen%2C+Ole%22">Madsen, Ole</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Olesen%2C+Oline+Vinter%22">Olesen, Oline Vinter</searchLink><relatesTo>3</relatesTo> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22International+Journal+of+Production+Research%22">International Journal of Production Research</searchLink>. Mar2026, Vol. 64 Issue 6, p2210-2232. 23p.
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  Data: <searchLink fieldCode="DE" term="%22Flexible+manufacturing+systems%22">Flexible manufacturing systems</searchLink><br /><searchLink fieldCode="DE" term="%22Continuous+processing%22">Continuous processing</searchLink><br /><searchLink fieldCode="DE" term="%22Pharmaceutical+chemicals+manufacturing%22">Pharmaceutical chemicals manufacturing</searchLink><br /><searchLink fieldCode="DE" term="%22Quality+assurance+standards%22">Quality assurance standards</searchLink><br /><searchLink fieldCode="DE" term="%22Aseptic+packaging%22">Aseptic packaging</searchLink><br /><searchLink fieldCode="DE" term="%22Production+engineering%22">Production engineering</searchLink><br /><searchLink fieldCode="DE" term="%22Protein+drugs%22">Protein drugs</searchLink>
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  Data: Biologically-based drugs can target a broader range of diseases with increased precision than traditional synthesised drugs, enabling the targeting of rare diseases. This shift impacts production systems, as batch sizes decrease and portfolio diversity increases. While initiatives exist to revolutionise production systems using state-of-the-art technologies, they often overlook the full life cycle of production systems holistically, including design, reconfiguration, and scaling. This paper outlines the pharmaceutical industry's need for purpose-built production systems that are fast to develop and modify. It proposes splitting traditional production systems into an aseptic production innovation factory and derived Good-Manufacturing-Practise-compliant aseptic production factories, both relying on a highly modular, changeable architecture. The proposed conceptual architecture is exemplified on various use cases, highlighting how it accelerates new products and technology introduction, supports employee training, and accelerates validation compared to conventional approaches. This is achieved by transitioning from digital design and simulation through the aseptic production innovation factory into validated aseptic production factories. While the architecture addresses key challenges of current pharmaceutical production systems, it is not without risk. Companies must take ownership of this architecture, especially its digital viewpoint, and rely on collaborations and co-development with technology providers to achieve modularity and reconfigurability across all structural levels. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of International Journal of Production Research is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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              Text: Mar2026
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