Live Biotherapeutic Products, A Road Map for Safety Assessment
Open accessAbstract
Recent developments in the understanding of the relationship between the microbiota and its host have provided evidence regarding the therapeutic potential of selected microorganisms to prevent or treat disease. According to Directive 2001/83/EC, in the European Union (EU), any product intended to prevent or treat disease is defined as a medicinal product and requires a marketing authorization by competent authorities prior to commercialization. Even if the pharmaceutical regulatory framework is harmonized at the EU level, obtaining marketing authorisations for medicinal products remains very challenging for Live Biotherapeutic Products (LBPs). Compared to other medicinal products currently on the market, safety assessment of LBPs represents a real challenge because of their specific characteristics and mode of action. Indeed, LBPs are not intended to reach the systemic circulation targeting distant organs, tissues, or receptors, but rather exert their effect through direct interactions with the complex native microbiota and/or the modulation of complex host-microbiota relation, indirectly leading to distant biological effects within the host. Hence, developers must rely on a thorough risk analysis, and pharmaceutical guidelines for other biological products should be taken into account in order to design relevant non-clinical and clinical development programmes. Here we aim at providing a roadmap for a risk analysis that takes into account the specificities of LBPs. We describe the different risks associated with these products and their interactions with the patient. Then, from that risk assessment, we propose solutions to design non-clinical programmes and First in Human (FIH) early clinical trials appropriate to assess LBP safety.
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Regulatory requirements for characterization of antimicrobial resistance genes in probiotics and biopharmaceuticals are set out in documents from EFSA, FDA, and FAO/WHO.
“Regulatory requirements for the characterization of antimicrobial resistance genes (AMR) in probiotics and biopharmaceuticals are set out in regulatory documents from regulatory bodies such as the EFSA, FDA, and FAO/WHO [34,124,125].”
From Current Concepts in Probiotic Safety and Efficacy (2026) · cites this paper as [125]
The Antimicrobial Resistance section (page unavailable) describes FDA guidance for antimicrobial susceptibility testing of live biotherapeutic products and recommends methods for identifying resistance genes. It also says the EFSA framework is not the right benchmark for evaluating sensitivity in patients. Our copy does not identify FAO/WHO documents setting requirements for characterizing resistance genes in probiotics or biopharmaceuticals. (LLM, conf=0.85)
Experimental — accuracy not yet measuredThe safety standard for dietary supplements requires that they be reasonably expected to be safe under the labeled conditions of use, but they do not need to be established as safe for more vulnerable patient populations.
“This is important because while the safety standard for dietary supplements requires that they will reasonably expected to be safe under the labeled conditions of use, they do not need to be established as safe for more vulnerable patient populations.9”
From Emerging issues in probiotic safety: 2023 perspectives (2023) · cites this paper as [9]
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Can polymeric nanofibers effectively preserve and deliver live therapeutic bacteria?
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Microbiome-based therapeutics for metabolic disorders: harnessing microbial intrusions for treatment
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Clinical application of live biotherapeutic products in infectious diseases
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Regulatory Considerations for Microbiome-Based Therapeutics
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Preclinical Assessment of Living Therapeutic Materials: State-of-Art and Challenges
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Probiotics and bioactive metabolite production
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Targeting vaginal dysbiosis: prospects for the application of live biotherapeutics products
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Microbiome additive therapy for the human health
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SAFETY DEMONSTRATION OF FOOD AND FEED CULTURES
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Gut Microbiota Dynamics and Their Role in Pathogenesis and Management of Diabetes
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Self-citationNatural products as functional food
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Self-citationFixing the Damage: The Evolution of Probiotics from Fermented Food to Biotherapeutic Products
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- Authors
- Rouanet, A., Bolca, S., Bru, A., Claes, I., Cvejic, H., Girgis, H., Harper, A., Lavergne, S. N., Mathys, S., Pane, M., Pot, B., Shortt, C., Alkema, W., Bezulowsky, C., Blanquet-Diot, S., Chassard, C., Claus, S. P., Hadida, B., Hemmingsen, C., Jeune, C., Lindman, B., Midzi, G., Mogna, L., Movitz, C., Nasir, N., Oberreither, M., Seegers, J. F. M. L., Sterkman, L., Valo, A., Vieville, F., & Cordaillat-Simmons, M.
- Affiliations
- Lallemand (France) (FR)
- Protexin (GB)
- Institut Mérieux (France) (FR)
- Probiotical (Italy) (IT)
- Vrije Universiteit Brussel (BE)
- Johnson & Johnson (United Kingdom) (GB)
- Nederlands Instituut Voor Zuivel Oonderzoek (NL)
- Ipsen (France) (FR)
- Université Clermont Auvergne (FR)
- Chr. Hansen (Denmark) (DK)
- PiLeJe (France) (FR)
- ORCID
- Venue
- Frontiers in Medicine
- Publisher
- Frontiers Media SA
- Published
- 2020-06-19
- Volume
- 7
- Pages
- 237-237
- ISSN
- 2296-858X (ISSN-L)
- PMC
- PMC7319051
- OpenAlex
- W3036229416
- Cited by
- 120
- References
- 74
- Citations by year
- 2026: 30 · 2025: 22 · 2024: 18 · 2023: 9 · 2022: 21 · 2021: 18 · 2020: 2
- FWCI
- 8.11
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Frontiers in Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- HAL (submittedVersion, cc-by)
- HAL (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- VUBIR (Vrije Universiteit Brussel) (submittedVersion)
- Topics
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Life Sciences › Agricultural and Biological Sciences › Food Science › Agricultural safety and regulations
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Keywords
- live biotherapeutic products, safety assessment, risk analysis, host-microbiota interactions, microbiota-based therapy, drug approval, regulatory framework
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