Cited by 43Probiotics and Fermented FoodsMicroencapsulation and Drying ProcessesAgricultural safety and regulations

Probiotic Development Strategy Centered on Stability and Regulatory Considerations

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Kim, Hye, Haque, Md Ariful, Razzak, Md Abdur, Jang, Min Ji, Song, Sehyeon, Ku, Seockmo·2026·Comprehensive Reviews in Food Science and Food Safety

Abstract

The development of probiotic strains has become a major focus in both academic and industrial research, driven by their health benefits and growing consumer demand. However, functional outcomes demonstrated under laboratory conditions often fail to align with the stability and large‐scale performance required for industrial applications, creating a major obstacle to commercialization. This gap underscores the need for standardized evaluation frameworks that integrate scientific validation with industrial performance metrics. This review critically examines the probiotic development pipeline, encompassing strain screening, resilience‐enhancing strategies, and global regulatory frameworks. Particular attention is given to the effects of production stressors such as heat, oxygen, and digestion on strain viability. Studies reporting up to a 31‐fold increase in survival after heat shock and up to a 100‐fold improvement through microencapsulation during drying are highlighted to illustrate both the potential and limitations of adaptive strategies. These findings reveal the strong strain specificity and inconsistent reproducibility of current approaches, offering important insights for strategic development. Furthermore, regulatory systems in the United States, European Union, Japan, Korea, and China are compared to emphasize how heterogeneity in classification, safety assessment, and functional substantiation complicates global market entry. This review delves into how harmonized evaluation frameworks and sustained collaboration between academia, industry, and regulatory authorities help to develop next‐generation probiotics by integrating functionality, safety, stability, industrial application, and regulation parameters to achieve balanced progress in efficacy, safety, scalability, and economic feasibility.

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  • Regulatory challenges affecting the commercialization of probiotics include the lack of harmonization of regulatory requirements, varying efficacy and safety standards, increasing costs, and complicating worldwide regulatory compliance, leading to differences in regional market access.

    “Regulatory challenges affecting the commercialization of probiotics include the lack of harmonization of regulatory requirements, which can vary by region (e.g., as with drugs or dietary supplements), leading to confusion in interpreting requirements. Efficacy and safety standards also vary, increasing costs and complicating worldwide regulatory compliance, which in turn leads to differences in”

    From Current Concepts in Probiotic Safety and Efficacy (2026) · cites this paper as [61]

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Cited by

Sorted by citations

Authors
Kim, H., Haque, M. A., Razzak, M. A., Jang, M. J., Song, S., & Ku, S.
Affiliations
Texas A&M University (US)
Corresponding author
Ku, Seockmo
Venue
Comprehensive Reviews in Food Science and Food Safety
Publisher
Wiley
Published
2026-01
Volume
25
Issue
1
Pages
e70320-e70320
ISSN
1541-4337 (ISSN-L)
OpenAlex
W7118273489
Cited by
43
References
10
Citations by year
2026: 43
FWCI
23.26
Type
journal article
Language
en
Open access
Locations
  • Comprehensive Reviews in Food Science and Food Safety (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • PubMed Central (publishedVersion, cc-by)
Funders
U.S. Department of Agriculture
Topics
  • Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
  • Life Sciences › Agricultural and Biological Sciences › Food Science › Microencapsulation and Drying Processes
  • Life Sciences › Agricultural and Biological Sciences › Food Science › Agricultural safety and regulations
Keywords
probiotics, strain stability, heat shock, microencapsulation, drying stress, oxygen stress, strain screening, probiotic regulation, regulatory framework, safety assessment, industrial production, commercialization, evaluation framework
MeSH terms
Probiotics

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