Ten years of the manufacturing classification system: a review of literature applications and an extension of the framework to continuous manufacture

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dc.check.date2025-05-06en
dc.check.infoAccess to this article is restricted until 12 months after publication by request of the publisheren
dc.contributor.authorLeane, Michaelen
dc.contributor.authorPitt, Kendalen
dc.contributor.authorReynolds, Gavinen
dc.contributor.authorTantuccio, Anthonyen
dc.contributor.authorMoreton, Chrisen
dc.contributor.authorCrean, Abinaen
dc.contributor.authorKleinebudde, Peteren
dc.contributor.authorCarlin, Brianen
dc.contributor.authorGamble, Johnen
dc.contributor.authorGamlen, Michaelen
dc.contributor.authorStone, Elaineen
dc.contributor.authorKuentz, Martinen
dc.contributor.authorGururajan, Bindhuen
dc.contributor.authorKhimyak, Yaroslav Z.en
dc.contributor.authorVan Snick, Bernden
dc.contributor.authorAndersen, Suneen
dc.contributor.authorMisic, Zdravkaen
dc.contributor.authorPeter, Stefanieen
dc.contributor.authorSheehan, Stephenen
dc.date.accessioned2024-07-03T15:35:48Z
dc.date.available2024-07-03T15:35:48Z
dc.date.issued2024-05-06en
dc.description.abstractThe MCS initiative was first introduced in 2013. Since then, two MCS papers have been published: the first proposing a structured approach to consider the impact of drug substance physical properties on manufacturability and the second outlining real world examples of MCS principles. By 2023, both publications had been extensively cited by over 240 publications. This article firstly reviews this citing work and considers how the MCS concepts have been received and are being applied. Secondly, we will extend the MCS framework to continuous manufacture. The review structure follows the flow of drug product development focussing first on optimisation of API properties. The exploitation of links between API particle properties and manufacturability using large datasets seems particularly promising. Subsequently, applications of the MCS for formulation design include a detailed look at the impact of percolation threshold, the role of excipients and how other classification systems can be of assistance. The final review section focusses on manufacturing process development, covering the impact of strain rate sensitivity and modelling applications. The second part of the paper focuses on continuous processing proposing a parallel MCS framework alongside the existing batch manufacturing guidance. Specifically, we propose that continuous direct compression can accommodate a wider range of API properties compared to its batch equivalent.en
dc.description.statusPeer revieweden
dc.description.versionAccepted Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationLeane, M., Pitt, K., Reynolds, G., Tantuccio, A., Moreton, C., Crean, A., Kleinebudde, P., Carlin, B., Gamble, J., Gamlen, M., Stone, E., Kuentz, M., Gururajan, B., Khimyak, Y. Z., Van Snick, B., Andersen, S., Misic, Z., Peter, S. and Sheehan, S. (2024) 'Ten years of the manufacturing classification system: a review of literature applications and an extension of the framework to continuous manufacture', Pharmaceutical Development and Technology, 29(5), pp. 395-414. https://doi.org/10.1080/10837450.2024.2342953en
dc.identifier.doihttps://doi.org/10.1080/10837450.2024.2342953en
dc.identifier.eissn1097-9867en
dc.identifier.endpage414en
dc.identifier.issn1083-7450en
dc.identifier.issued5en
dc.identifier.journaltitlePharmaceutical Development and Technologyen
dc.identifier.startpage395en
dc.identifier.urihttps://hdl.handle.net/10468/16092
dc.identifier.volume29en
dc.language.isoenen
dc.publisherTaylor & Francisen
dc.rights© 2024, Informa UK Limited, trading as Taylor & Francis Group. All rights reserved. This is an Accepted Manuscript of an article published by Taylor & Francis in Pharmaceutical Development and Technology, on 6 May 2024, available online: https://doi.org/10.1080/10837450.2024.2342953en
dc.rights.urihttps://creativecommons.org/licenses/by-nc/4.0/en
dc.subjectTableten
dc.subjectCapsuleen
dc.subjectFormulationen
dc.subjectDevelopmenten
dc.subjectBatchen
dc.subjectContinuous manufacturingen
dc.subjectGranulationen
dc.subjectPharmaceuticalen
dc.subjectManufacturingen
dc.subjectProcess developmenten
dc.titleTen years of the manufacturing classification system: a review of literature applications and an extension of the framework to continuous manufactureen
dc.typeArticle (peer-reviewed)en
oaire.citation.issue5en
oaire.citation.volume29en
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