MINI REVIEW article

Front. Bacteriol., 18 August 2026

Sec. Molecular Bacteriology and Microbiome

Volume 5 - 2026 | https://doi.org/10.3389/fbrio.2026.1886299

Unravelling biofilm complexity: a regulatory science perspective

  • Medicines and Healthcare products Regulatory Agency, South Mimms, United Kingdom

Abstract

Biofilms are a substantial problem across many sectors, with a frequently cited estimated global economic cost of >$5 trillion. In the healthcare setting, biofilm-associated infections have a significant impact on patient management and quality of life. They are difficult to eradicate and treat and contribute to escalating antimicrobial resistance. There are a multitude of methods for investigating biofilms, most designed to mimic in vivo conditions in an in vitro environment, but without standardisation, assay reproducibility and confidence is lost. The community needs validated, reproducible and harmonised approaches to support research and innovation underpinned by physical reference materials and written standards. Furthermore, clarity around the type of evidence needed to make and substantiate antibiofilm claims is needed; despite growing innovation in antibiofilm research, regulatory pathways remain unclear. This review discusses challenges and opportunities for biofilm innovation and highlights where regulatory science can aid and support progress.

1 Introduction

Microorganisms rarely exist as free-floating cells in nature; instead, they predominantly live within structured communities known as biofilms. Biofilms are colonies of bacterial and fungal species, which are often polymicrobial, that proliferate and behave as a single entity and are encased by extracellular matrix (ECM). They are a pervasive and globally significant problem, particularly within healthcare, where biofilm-associated infections complicate treatment and negatively impact patient outcomes. These infections are difficult to eradicate due to the inherent tolerance of biofilm communities to antimicrobial therapies, contributing to treatment failure and the escalating threat of antimicrobial resistance. As a result, there has been substantial growth in research aimed at understanding biofilm biology to develop therapeutics. A wide range of experimental models have been developed to study biofilms in vitro (), often designed to replicate in vivo environments. However, considerable variability between methodologies has impacted inter- and intra-laboratory reproducibility. This lack of harmonisation presents a significant challenge for translating promising antibiofilm innovations into clinically viable technologies.

The community needs validated, reproducible, and standardised approaches to investigate biofilms. While written standards for biofilm testing (characterisation and antibiofilm testing) are emerging, there remains a critical gap in the development of physical reference materials to support and realise these standards and enable robust benchmarking of assays, diagnostics, and therapeutics. This is particularly important in the context of regulation. People developing antibiofilm technologies are unclear about regulatory expectations, creating additional barriers to translation. This review explores the emerging need for harmonised biofilm methodologies, progress towards the development of physical reference materials, and opportunities for more accessible regulatory guidance to support innovation in this rapidly evolving field.

2 Significance of biofilms

A frequently cited estimate suggests that biofilms may contribute to economic losses approaching $5 trillion globally across multiple sectors including healthcare, industrial, environmental, and infrastructure sectors (). However, this figure represents a broad aggregate estimate and should be interpreted with caution. Much of this cost comes from biofouling and corrosion, but the healthcare and medical sectors are the next largest and make up a substantial amount of this total figure. In the healthcare sector, biofilms contribute to foreign-body related infections (FBRI), such as prosthetic joint infections (PJI), polymicrobial urinary catheter infections () and other catheter-related infections (; Vilchez et al., 2021) and non-surface associated infections, such as cystic fibrosis (CF) (), chronic wound infections (Wei et al., 2019), and vulvovaginal candidiasis (Pan et al., 2023). This has a significant economic burden (through healthcare associated costs and lost working days) as well as increased mortality and poor quality of life for patients (Xu et al., 2023).

Biofilm infections are notoriously difficult to treat, are intrinsically more tolerant to antibiotics and antifungals, and are adept at acquiring resistance (Kaur and Nobile, 2023; Liu et al., 2024) Resistance to antimicrobials can be through true genetic resistance as well as physiological tolerance and quorum sensing (QS). Acquired antimicrobial resistance (AMR) arises through mutation and horizontal gene transfer (HGT), which occurs readily in biofilms, and confers resistance in the traditional sense e.g., structure/function changes to the antibiotic target, reduced uptake of drug into the cell, efflux pumps (Uruén et al., 2020; ). The connection between HGT and biofilm formation has been demonstrated previously (Madsen et al., 2012). Conjugation, a mechanism of HGT where genetic material is transferred directly through cell-to-cell contact, happens frequently due to close proximity of the cells as a result of the structure and organisation of the biofilm (Sørensen et al., 2005; Madsen et al., 2012).

Physical (rather than genetic) resistance and tolerance/persistence to antimicrobials is a unique feature of biofilms (). Antimicrobials can fail to penetrate the incredibly protective ECM, which is mostly made up of thick and sticky polysaccharides, proteins and extracellular DNA (eDNA) (Sutherland, 2001). The ECM confers many defensive benefits to the biofilm; it provides structure, stability, resource and nutrition capture, and inhibits entry of large molecules (such as antimicrobials) and lymphocytes (). It has been shown that the matrix allows biofilms to resist killing by neutrophils, as neutrophils can only phagocytose bacteria less than 10μm; biofilms beneath the matrix are greater than 100μm and are unattainable for neutrophil killing (Kovach et al., 2017). Biofilms are inherently slow growing, and when they grow to maturity growth becomes stationary, where dormant cells form readily due to decreased oxygen levels and decreased nutrient levels (). This dormancy prevents antimicrobials which inhibit the synthesis of the cell wall, such as beta lactams and glycopeptides in bacteria and echinocandins in fungi, from having an effect. Cellular metabolism is much slower in biofilm cells, and as with planktonic cells that show increased tolerance with decreased metabolism, the same is true of cells within the biofilm (). QS is a sophisticated method of microbial communication influenced by cell density and small molecule autoinducer signals synthesised from bacterial cells (e.g. acylated homoserine lactones and autoinducing peptides (Ruan et al., 2026)) and fungal cells (e.g. farnesol and tyrosol ()). QS is highly coordinated and directly affects the physiological processes of biofilms; it occurs in bacteria (both Grma-positive and Gram-negative) and fungi (their autoinducers are different, but work in the same way) and induces changes in gene regulation, including those for biofilm formation, AMR and virulence to enhance survival (Zhao et al., 2020; ; ).

These characteristics have driven extensive research and development of innovations targeting biofilm formation, virulence mechanisms, and extracellular matrix disruption. This growing diversity of anti-biofilm approaches further emphasises the need for validated, reproducible and harmonised methods.

3 Current standardisation initiatives

Concerns regarding reproducibility in biomedical science have intensified in recent years, with biofilm research increasingly recognised as particularly susceptible to variability. The reproducibility crisis refers to a widespread concern in science that many published research results cannot be reproduced or replicated when other researchers repeat the same experiments or analyses. The reproducibility crisis was highlighted in 2015 by a large study looking at the reproducibility of psychology studies (Open Science Collaboration, 2015), and this has been mirrored by companies like Amgen in the biomedical science field also (). Reference materials and standardisation are tools that help the scientific community tackle issues around reproducibility, harmonisation, and accuracy; metrology is seldom taught to undergraduates or discussed outside metrology circles, but it has huge value assuring the quality of scientific research ().

A wide range of experimental approaches are currently used to study biofilms, spanning from relatively simple high-throughput systems to more complex, physiologically relevant models – a balance must be struck between the challenge of mimicking the natural behaviour and growth of biofilms and the ease and ability to undertake reproducible and high-throughput experimentation. Basic platforms, such as microtitre plates and Calgary Biofilm Devices, are widely employed due to their accessibility, low cost, and suitability for screening disinfectants or environmental samples (; ), but these simplified models may be less appropriate for evaluating novel therapeutics, particularly non-traditional antimicrobials (NTAs) or immune-modulating agents, where host–pathogen interactions, host immune factors, and biofilm architecture are critical. Although simple assays, including crystal violet staining for biomass, are attractive for routine use, they often produce heterogeneous and poorly reproducible results, limiting their utility for regulatory decision-making (Peeters et al., 2008; ).

Additionally, there is a distinct absence of a universally accepted definition of a biofilm, which compounds the issue of result comparability across studies and is a significant barrier to standardisation. While biofilms are commonly described as microbial communities associated with a surface and embedded within a self-produced ECM, numerous definitions exist that place differing emphasis on surface attachment, matrix production, community structure, spatial organisation, and phenotypic characteristics. This lack of consensus complicates the development of harmonised experimental methods, the comparison of data between studies, and the establishment of reference materials and performance standards. Greater agreement on the defining characteristics of a biofilm may therefore represent an important step towards improved standardisation across the field.

Several international initiatives are attempting to address these challenges and improve standardisation in biofilm regulatory science. The National Biofilm Innovation Centre (NBIC) (National Biofilms Innovation Centre (NBIC), 2026), through its International Biofilm Standards Task Group, brings together stakeholders from academia, industry, and regulatory environments, including the USA Center for Biofilm Engineering, the Singapore Centre for Environmental Life Sciences Engineering, and the COST Action on Anti-Microbial Coating Innovations to Prevent Infectious Diseases. These collaborations aim to collate current evidence and disseminate best practices across diverse sectors, including human health, agriculture, water systems, and engineering. NBIC, like with many other scientific centre initiatives, is limited by its dependency on funding, which can result in fluctuating activities and fragmented outputs. In parallel, the COST initiative “Building Consensus on Biofilm Regulatory Decision Making” () seeks to develop a Regulatory Toolbox through coordinated working groups focused on standardised technologies, data translation for decision-making, and communication. The overarching goal of these efforts is to bridge the gap between rapidly evolving academic biofilm research and regulatory science, thereby supporting consistent and informed evaluation of anti-biofilm products. The COST Action is limited in its timeframe with a short-term lifespan (4 years), which may result in limited continuity of established work. Additional contributions are being made by organisations such as the Biofilm Alliance (), which is a large network of biofilm researchers in academia, industry, metrology, regulatory bodies, and standardisation organisations who want to bridge the gap between research and regulation. The biggest limitation with these organisations is that they are not regulatory or standards bodies, therefore cannot formalise methods, although NBIC does have strong leadership in this area, or define regulatory frameworks.

There are standards bodies including the British Standards Institution (BSI), which has established a dedicated committee to develop written standards for biofilm-related testing CH/216/-/3 Biofilms and Products () and the American National Standards Institute, which houses the ASTM written standards (). The written standards reduce variability in industrial biofilm testing, antimicrobial surface evaluation, water system contamination, disinfectant testing and in materials science. Many of these initiatives aim to achieve broad consensus across multiple sectors, which may be challenging given the differing requirements of healthcare, environmental, industrial, and food applications and may be why they have had limited adoption in all sectors. They are often inflexible, have a long lead-time to publication, and often sit behind a paywall. Biofilms differ fundamentally depending on; the species present (bacteria, fungi, polymicrobial), the environment (healthcare device, water system, soil, marine), growth conditions (flow, nutrients, shear force) and maturity stage. Therefore a “standard” method will either be overly simplified and loses the real-world evidence, or overly complex and is not reproducible or scalable. Therefore, standards will become irrelevant or unusable. Rather than enforcing rigid methodological prescriptions, performance-based standards may offer a more practical approach. Such standards would specify key experimental parameters relevant for the type of biofilm, including; model system, microorganism, growth conditions, contact times, replication strategy, and efficacy thresholds, while allowing flexibility in model selection.

4 Translational challenges in anti-biofilm innovation and the need for physical standardisation

Developing standardised approaches for biofilm testing requires distinguishing between standardising assays and standardising products. Although standardisation is essential to improve reproducibility, comparability, and regulatory acceptance of biofilm methods, it is important to recognise that biofilms are inherently heterogeneous biological systems. Biofilm phenotype is influenced by numerous factors, including species composition, biofilm architecture, developmental stage, nutrient availability, and environmental or host-associated conditions. In particular, polymicrobial biofilms often exhibit emergent properties that cannot be predicted from monospecies models, owing to complex interspecies and interkingdom interactions that influence biofilm structure, ECM production, antimicrobial tolerance, and persistence. Recent studies have highlighted the importance of incorporating polymicrobial systems into biofilm research, as these more closely resemble many clinically and environmentally relevant biofilms than conventional monospecies models. Spatial metabolic heterogeneity, the presence of persister cell populations, and variability in extracellular polymeric substance composition create additional layers of complexity that may limit the applicability of universal testing approaches (Nithyanand et al., 2025). Consequently, while harmonisation of methodologies, reporting practices, and reference materials should remain a priority, a single standardised biofilm model is unlikely to be appropriate across all sectors and applications. Therefore, the goal should not necessarily be the development of a universal biofilm model, but rather the establishment of fit-for-purpose methodologies underpinned by reference materials and common principles for biofilm cultivation, characterisation, data reporting, and method validation.

A wide range of anti-biofilm technologies are already available or in development, including antimicrobial peptides for PJI (Peptilogics, 2026), monoclonal antibodies for PJI (), antimicrobial coatings, wound care products, and disinfectants (Weigelt et al., 2021; ; Zou et al., 2025), but few human medicines are licensed specifically with anti-biofilm claims. Dornase alfa (Pulmozyme) is a molecule that is the most closely cited example of an approved anti-biofilm product; it is a USA Food and Drug Administration (FDA) approved molecule that directly degrades eDNA and is used in CF, a clinically biofilm-driven disease (), but the formal indication is not for the treatment of biofilms explicitly. Azithromycin is an example of an antibiotic that never originally had an anti-biofilm claim but has subsequently been demonstrated to have excellent activity against Pseudomonas biofilms in some conditions (Mulet et al., 2009; Wang et al., 2024).

Despite rapid advances in biofilm research, substantial barriers remain between laboratory discovery and clinical application. Many promising approaches demonstrate efficacy in simplified in vitro systems but fail to translate into clinical benefit (; Vyas et al., 2022; Supparitsch and Zeitlinger, 2026). This translational gap reflects the complexity of biofilm-associated infections, which are influenced by host responses, tissue architecture, nutrient gradients, polymicrobial interactions, and environmental conditions that are difficult to replicate experimentally. Emerging strategies including matrix-degrading enzymes, bacteriophage therapies, antimicrobial and anti-adhesive coatings, quorum sensing inhibitors, and repurposed drugs often target biofilm-specific processes rather than viability alone (; ; Li et al., 2026). Consequently, efficacy assessment increasingly requires non-traditional efficacy endpoints, such as inhibition of attachment, matrix disruption, or virulence modulation.

Predicting clinical efficacy from laboratory models therefore remains challenging. Biofilm susceptibility varies according to factors including shear stress, nutrient availability, microbial composition, and biofilm maturity (Stewart, 2002; Stewart and Franklin, 2008). In practice, biofilms are grown, challenged, and analysed using heterogeneous methods that often reflect local or historical laboratory practice. Growth conditions differ substantially depending on whether models are intended to represent clinical infection, industrial contamination, or environmental biofilms, with variation in nutrient composition, temperature, flow conditions, and surface properties. Although in vitro systems provide experimental control, they frequently fail to reproduce host immune interactions and physiological gradients present in vivo (Supparitsch and Zeitlinger, 2026). More complex systems such as flow chambers, drip-flow reactors, and fermenters offer improved physiological relevance but require specialised equipment, contributing further methodological diversity between laboratories (; Tolker‐Nielsen and Sternberg, 2011).

Additional variability arises during antimicrobial exposure and downstream analysis. Biofilms respond dynamically to environmental changes, with relatively minor differences in oxygen availability, temperature, or nutrients altering gene expression, metabolic activity, and matrix production (White-Ziegler et al., 2008; ). Experimental challenge conditions may also differ from clinically relevant exposure scenarios, while harvesting and neutralisation methods can influence susceptibility measurements (). Some antimicrobials alter biofilm adhesion or structural integrity, affecting detachment efficiency and quantification. Together, these variables make it difficult to distinguish genuine antibiofilm activity from model-specific artefacts and contribute to inconsistent outcomes across studies.

Agreed maturity markers, standardised endpoints, and reproducible testing conditions would improve comparability and support regulatory evaluation without constraining innovation. Physical reference materials could further strengthen assay harmonisation by providing benchmarks for diagnostic and therapeutic testing. However, developing such materials is challenging because there is currently no consensus on how biofilms should be grown or defined. Biofilm properties depend heavily on species composition, including mono- versus polymicrobial communities, which differ in structure, growth kinetics, and antimicrobial tolerance (Stoodley et al., 1999; ; Stewart and Franklin, 2008). Defining maturity is similarly problematic, as incubation time is often used as a proxy despite substantial variation between organisms and limited confirmation of extracellular polymeric substance production (Sauer et al., 2022).

A key challenge in advancing biofilm standardisation is defining what constitutes an appropriate biofilm reference material. Unlike recombinant proteins or chemical reference standards, biofilms are living, dynamic and highly context-dependent systems whose structure and function change over time in response to environmental conditions. Consequently, a universal biofilm reference material is difficult to envisage. One potential approach is the development of biological reference biofilms, consisting of well-characterised strains grown under tightly controlled conditions, for example Pseudomonas aeruginosa PAO1 cultivated in a standardised flow-cell system using defined media, growth periods and shear conditions. Such materials could be characterised by reference values for biomass, thickness, viability, ECM composition and cell density (Figure 1). However, their utility would be limited by short shelf-life, challenges associated with inter-laboratory distribution and their inherently species-specific nature. An alternative strategy may be the development of artificial matrix-based reference materials composed of representative biofilm matrix components, such as polysaccharides, proteins and eDNA. These materials would offer greater stability, reproducibility and ease of distribution and could facilitate calibration of imaging systems, evaluation of anti-matrix therapeutics and assessment of ECM-disrupting technologies. Nevertheless, ECM composition varies substantially between species and environments (; Karygianni et al., 2020), limiting the applicability of any single formulation. A more realistic and broadly applicable approach may therefore be the adoption of analytical reference materials designed to standardise measurements rather than the biofilm itself.

Figure 1

In this context, biofilm maturity may be more effectively defined through biological characteristics than through arbitrary growth periods. The biofilm matrix is a key determinant of the transition from surface-attached cells to a mature biofilm phenotype (; , ; Karygianni et al., 2020; Ragupathi et al., 2024) and may therefore represent a useful target for standardisation. Rather than defining a biofilm solely by age (e.g., 24 or 48 hours), it may be preferable to define maturity based on quantitative thresholds of matrix-associated biomarkers. Although a universal ECM biomarker is unlikely given the substantial differences in matrix composition between organisms (Karygianni et al., 2020), classes of matrix components, including polysaccharides, eDNA and matrix-associated proteins, could potentially serve as measurable indicators of biofilm maturation. Quantification using established assays for carbohydrate content, eDNA and protein concentration may provide biologically relevant metrics that are applicable across multiple biofilm systems.

Standardisation of analytical methods, reference strains, matrix-characterisation approaches, imaging protocols and data-reporting frameworks is likely to be achievable across sectors, whereas universal standards for biofilm composition, polymicrobial community structure, host-associated biofilms or antimicrobial efficacy are unlikely to reflect the biological diversity observed in real-world biofilm systems. Determining how similar physical reference materials could be most effectively applied to biofilm research remains an important area for future development.

5 Clearer regulatory pathways for anti-biofilm technologies

Anti-biofilm innovations are often classed as NTAs and frequently do not conform to conventional pharmacological paradigms, such as demonstrating a minimum inhibitory concentration (MIC). Subsequently, developers may be concerned that regulators will be reluctant to accept alternative forms of experimental evidence. This concern typically stems from the perception that regulatory assessment is primarily geared toward traditional small-molecule antibiotics. However, this is not generally the case. Regulatory agencies routinely evaluate innovative products and are accustomed to reviewing novel technologies, mechanisms of action, and non-standard methodologies. While the concern is understandable, it is often driven more by uncertainty regarding regulatory expectations than by actual regulatory barriers.

In the UK, Europe and USA (MHRA, European Medicines Agency (EMA), FDA), there is no biofilm-specific regulatory guidance for product developers (Table 1). Instead, biofilms are treated implicitly within broader frameworks, such as medicinal products, medical devices and borderline/combination products – the primary function of the product will determine what category they fall into. It is beyond the scope of this review to provide information on each country’s regulatory procedures, however it is important to highlight that regulators can provide scientific advice to product developers and this should be utilised as there is a two-fold benefit; the developer receives appropriate advice and the regulator benefits from horizon scanning to better support in the future.

Table 1

AspectMHRAFDAEMA/Europe
Biofilm-specific guidanceNoneNoneNone
Written standards relianceBSI, British Pharmacopoeia, ISOASTM-heavyISO/CEN-heavy, European Pharmacopoeia
Physical standards developmentNational Institute for Biological Standards and Controls (NIBSC)Center for Biologics Evaluation and Research (CBER), National Institute of Standards and Technology (NIST)None – reliance on Official Medicines Control Laboratories (which includes NIBSC)

Comparative summary of the regulatory approaches adopted by the MHRA, FDA, and EMA for biofilm-related medical product evaluation, including guidance availability, standards reliance, and physical reference standards.

The current situation for anti-biofilm innovation developers is analogous to challenges recently encountered in the therapeutic bacteriophage field. The bacteriophage community identified several perceived regulatory barriers, many of which arose from misunderstandings rather than actual limitations. Developers often assumed that bacteriophages were incompatible with existing regulatory frameworks, despite their accommodation within established pathways, broadly within the biological medicines framework (WHO Biologicals, 2026). Common concerns included the belief that medicines regulation applies only to small molecules, that complex biological therapies fall outside existing regulations, and that regulators require universal efficacy or superiority over existing treatments.

Such perceptions were reinforced by limited engagement between developers and regulators, leading to uncertainty regarding acceptable evidence and regulatory pathways. This lack of communication contributed to misinformation and slowed progress. In response to the UK Science Innovation and Technology Committee inquiry into the therapeutic potential of bacteriophages, the MHRA published a document of regulatory considerations for therapeutic bacteriophages (), supported by interpretive materials developed with the scientific community () – no new regulation was needed, but people needed the relevant information signposted and made accessible. This was also mirrored by the EMA who have drafted guidelines for phage therapy quality aspects (), and the European Pharmacopoeia ().

This example illustrates the importance of parallel evolution between innovation and regulation. Early engagement enables regulators to identify emerging technologies and adapt frameworks and regulatory science support where needed or provide steer on appropriate frameworks and evidentiary expectations. Without such dialogue, uncertainty may persist, potentially delaying the translation of innovative anti-biofilm approaches into clinical use.

6 Conclusion

Biofilms represent a major and growing challenge across healthcare and other sectors, contributing to persistent infections, antimicrobial resistance, and substantial economic burden. It also presents opportunities for innovation and economic growth. Despite advances in biofilm biology and rapid innovation in anti-biofilm technologies, translation into clinically effective solutions remains limited. Variability in experimental models, organisms, growth conditions, and analytical methods reduces reproducibility and complicates comparison across studies, making it difficult to predict clinical performance. Harmonisation of biofilm research methodologies is therefore essential. The development of physical reference materials represents a critical next step, enabling benchmarking, supporting assay validation, and improving confidence in preclinical data.

Looking forward, progress in biofilm regulatory science will require coordinated action across the research, standards, and regulatory communities. In the short term (1–3 years), priorities should include reaching greater consensus on the defining characteristics of biofilms, improving reporting standards, validating reproducible assay methodologies, and developing candidate physical and analytical reference materials. In the medium term (3–7 years), these efforts should translate into internationally harmonised performance-based standards, wider adoption of reference materials, and regulatory guidance describing appropriate evidence requirements for anti-biofilm claims across medicines, medical devices, diagnostics, and antimicrobial technologies. In the longer term (7–10 years), regulatory frameworks should incorporate validated biofilm-specific endpoints into product evaluation, supported by internationally recognised reference standards and globally aligned regulatory approaches. Achieving these milestones will require collaboration between academic researchers, industry, metrology institutes, standards organisations (e.g. BSI, ASTM, ISO), regulatory agencies (e.g. MHRA, EMA, FDA), funding bodies, and collaborative initiatives such as NBIC, COST Action CA23152, and the Biofilm Alliance. Such coordinated efforts will help establish a robust regulatory ecosystem that supports innovation while ensuring that anti-biofilm technologies are evaluated using reproducible, clinically relevant, and internationally accepted methods.

Statements

Author contributions

LC: Conceptualization, Writing – original draft, Writing – review & editing. CC: Writing – review & editing.

Funding

The author(s) declared that financial support was received for this work and/or its publication. LC and CC are both funded by the UK Department for Health and Social Care (DHSC) Global Antimicrobial Innovation Fund (GAMRIF). The funder was not involved in the study design, collection, analysis, interpretation of data, the writing of this article, or the decision to submit it for publication.

Acknowledgments

The authors would like to acknowledge The National Biofilms Innovation Centre (NBIC), including the Biofilm Alliance and The EU COST Action for Biofilms.

Conflict of interest

The author(s) declared that this work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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The author(s) declared that generative AI was not used in the creation of this manuscript.

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Publisher’s note

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.

References

Summary

Keywords

biofilms, one health, regulatory science, reproducibility, standardisation

Citation

Cleaver LM and Coxon CH (2026) Unravelling biofilm complexity: a regulatory science perspective. Front. Bacteriol. 5:1886299. doi: 10.3389/fbrio.2026.1886299

Received

20 May 2026

Revised

09 July 2026

Accepted

20 July 2026

Published

18 August 2026

Volume

5 - 2026

Edited by

Balaji Kannan, University of Maryland, United States

Reviewed by

P Nithyanand, SASTRA University, India

Morenike Omotayo Adeola, Dennis Osadebay University, Nigeria

Updates

Copyright

*Correspondence: Leanne M. Cleaver,

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.

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