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Chemistry, manufacturing, and controls for live microbial products: addressing classification challenges and
Ralph Slijkerman1, Rob van Dijk2, Nasser Mohieddin3
1Department of Manufacturing Science and Technology (Production), Wacker Biotech B.V., Amsterdam, Netherlands.
Frontiers in Microbiomes
|March 19, 2026
Summary
Process validation for live microbial products (LMPs) requires tailored approaches due to unique challenges, especially for injectables. This review compares guidelines and clinical trials to advance LMP development and commercialization.
Area of Science:
- Microbiology
- Pharmaceutical Sciences
- Regulatory Affairs
Background:
- Live microbial products (LMPs) present unique manufacturing and validation challenges distinct from traditional pharmaceuticals.
- Existing regulatory frameworks, particularly for injectable LMPs, are not fully adapted to accommodate the nature of living organisms.
- Sterility requirements for injectables conflict with the inherent viability of LMPs, necessitating specific safety considerations.
Purpose of the Study:
- To outline and compare regulatory guidelines relevant to various subcategories of LMPs.
- To identify and address specific challenges in the development of LMPs, particularly for injectable formulations.
- To provide a comprehensive overview to facilitate the progression of LMPs from development to commercialization.
Main Methods:
- Holistic review and comparison of existing LMP-relevant guidelines from regulatory bodies.
- Analysis of product characteristics to determine appropriate regulatory categories and applicable guidelines.
- Collection and analysis of all LMP-related clinical trials to understand development challenges and solutions.
Main Results:
- Live microbial products (LMPs) necessitate customized process validation strategies, differing from traditional drug products.
- Injectable LMPs face regulatory hurdles due to the conflict between sterility requirements and product viability.
- Key safety attributes for LMPs include absence of contaminants and confirmed monoseptic condition.
Conclusions:
- Tailored process validation is crucial for the successful development and commercialization of live microbial products.
- Addressing the specific challenges of LMPs, especially injectables, requires a nuanced regulatory approach.
- A comprehensive understanding of guidelines and clinical trial data is essential for advancing LMP therapies.
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