REVIEW article
Front. Microbiomes
Sec. Host and Microbe Associations
Volume 4 - 2025 | doi: 10.3389/frmbi.2025.1569348
This article is part of the Research TopicLive Biotherapeutic Products: Where Are We?View all 9 articles
Chemistry, Manufacturing, and Controls (CMC) for Live Microbial Products: Addressing Classification Challenges and Enhancing Process Validation
Provisionally accepted
- Wacker Chemie (Germany), Munich, Germany
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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 applicable guidelines.All LMPs fall under regulations related to GMP-compliant manufacturing however, there are microbial-specific challenges. Both FDA and EMA do not have a regulatory framework for LMPs administrated by injection. Full adherence to general guidelines for injectables is technically not feasible for LMPs, as sterility is required, which conflicts with living microorganisms as a product. Safety-related critical quality attributes (CQAs) of such LMPs typically include absence of contaminants and proof of monoseptic condition of the product. In this paper, it is tried to holistically outline and compare LMP-relevant guidelines and highlight different sub-categories.Additionally, the status of the field is captured by collecting all LMP-related clinical trials to resolve specific challenges in LMP development. Taken together, this overview will aid in bringing future LMPs from development to commercialization.
Keywords: Live Microbial Product (LMP) 1, injection 2, regulatory 3, classification 4, Live Biotherapeutic Product (LBP) 5, Live Bacterial Therapeutic (LBT) 6, monoseptic 7 commercialization 8
Received: 31 Jan 2025; Accepted: 27 May 2025.
Copyright: © 2025 Van Dijk, Schuler, Slijkerman, Ciarlante, Mohieddin and de Jong. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Rob Van Dijk, Wacker Chemie (Germany), Munich, Germany
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.