Chemistry, manufacturing, and controls for live microbial products: addressing classification challenges and enhancing process validation

Traditional process validation life cycles need to be tailored to the specific needs of live microbial products (LMPs). LMPs can be divided into subcategories, and the product characteristics are the basis for the regulatory category and thereby the applicable guidelines. All LMPs fall under regulat...

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Bibliographic Details
Main Authors: Ralph Slijkerman, Rob van Dijk, Nasser Mohieddin, Ivana Ciarlante, Antal de Jong, Moira Monika Schuler
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-06-01
Series:Frontiers in Microbiomes
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/frmbi.2025.1569348/full
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