Mrs. Kim Boue

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Janssen R&D, Belgium
Kim Boué, MSc, is an Associate Director of CMC Regulatory Affairs at Janssen Pharmaceuticals, where she is the CMC regulatory person responsible for several small molecule development projects. She has led several regulatory submission and filing strategies, including interactions with different health authorities worldwide resulting in approvals of NCEs. Currently, she also plays a central role in the ongoing scientific discussions with FDA’s ETT and EMA’s PAT on continuous manufacturing and related topics. Kim holds a MS as a bioengineer in cell and gene biotechnology from The University of Leuven (Bel-gium). She joined ISPE in 2021.

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Regulatory Aspects of Global Acceptance of Continuous Manufacturing
Features
Regulatory Aspects of Global Acceptance of Continuous Manufacturing

Application of continuous manufacturing (CM) in the pharmaceutical industry is gaining momentum. Most of the current experience is based on oral solid dosage (OSD) projects but in the future continuous manufacturing should not be limited to these dosage forms. In this article, the regulatory acceptability of continuous manufacturing to produce pharmaceuticals is demonstrated in different...