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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DOI:10.1080/10837450.2024.2342953
作者：Michael Leane, Kendal Pitt, Gavin Reynolds, Sune Andersen, Brian Carlin, Abina Crean, John Gamble, Michael Gamlen, Bindhu Gururajan, Yaroslav Z. Khimyak, Peter Kleinebudde, Martin Kuentz, Zdravka Misi
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Taylor & Francis

Abstract：The 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 p

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