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Microbial Safety Assessment & Regulatory Services

Integrated strain, functional, and product-level safety assessment to support global regulatory approval.

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Comprehensive Microbial Safety Assessment for Regulatory Approval

BaseClear provides a fully integrated microbial safety assessment framework, combining regulatory expertise, laboratory testing, and genomics. Our approach is structured around three key pillars: strain-level safety, functional risk assessment, and product-level safety. This ensures that all regulatory expectations are addressed coherently, enabling efficient dossier preparation and reducing approval timelines.

Services

Whole Genome Sequencing (WGS) for Strain Characterization

BaseClear provides high-quality, full-service WGS solutions, covering the entire workflow from DNA extraction and library preparation to sequencing, genome assembly, and bioinformatics analysis for microbial strain characterization. Our analyses include taxonomic identification, detection of AMR genes, virulence factors, toxin genes, BGCs associated with potentially harmful metabolites, and mobile genetic elements, as well as tailored analyses based on specific project needs. Results are delivered in dossier-ready reports aligned with current EFSA requirements for microorganisms used in the food chain.

90 %
BaseClear
1
BaseClear
1000
BaseClear
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Antimicrobial susceptibility test (MIC-testing)

BaseClear supports MIC testing to determine antimicrobial susceptibility profiles of microbial strains. Testing is performed using standardized methods and interpreted against relevant regulatory cut-off values where available. The results support AMR risk assessment and provide clear conclusions for regulatory submissions.

90 %
BaseClear
1
BaseClear
1000
BaseClear
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Antimicrobial Production Testing

BaseClear assesses whether microbial strains produce or products contain antimicrobial substances under defined test conditions. This service is performed by using appropriate indicator organisms, controls, and culture conditions to evaluate antimicrobial activity. The outcome helps determine whether antimicrobial metabolite production may require further safety consideration.

90 %
BaseClear
1
BaseClear
1000
BaseClear
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Cytotoxicity Testing

BaseClear offers in vitro cytotoxicity testing using Vero cells to evaluate potential cytotoxic effects of microbial cultures, culture supernatants, or final product extracts. The assay is designed with defined exposure conditions, controls, and acceptance criteria to support toxicological risk assessment. Results can be integrated into a weight-of-evidence safety evaluation for regulatory submissions.

90 %
BaseClear
1
BaseClear
1000
BaseClear
Learn more

Presence of viable cells of the strain

BaseClear designs and supports testing to determine the presence or absence of viable production organisms in final products. Studies are tailored to the product matrix and include appropriate enrichment, selective or non-selective culture conditions, controls, and detection limits. The results provide evidence needed to demonstrate product-level safety and regulatory compliance.

90 %
BaseClear
1
BaseClear
1000
BaseClear
Learn more

Presence of DNA from the strain

BaseClear supports testing to determine the presence or absence of residual DNA, including strain-specific or recombinant DNA where relevant, in final products. The study design can include matrix-specific DNA extraction, assay controls, sensitivity assessment, and defined limits of detection. Results are reported in a format suitable for regulatory dossiers and product safety conclusions.

90 %
BaseClear
1
BaseClear
1000
BaseClear
Learn more

Regulatory Strategy & Dossier Development

We support clients across the full regulatory pathway, including gap analysis, study planning, literature review and dossier preparation for EFSA, FDA, and other authorities. Our team ensures that all data are integrated into a coherent, submission-ready package.

90 %
BaseClear
1
BaseClear
1000
BaseClear
Learn more

Services

Whole Genome Sequencing (WGS) for Strain Characterization

BaseClearprovides high-quality, full-service WGS solutions, covering the entire workflow from DNA extraction and library preparation to sequencing, genome assembly, and bioinformatics analysis for microbial strain characterization. Our analyses include taxonomic identification, detection ofAMRgenes, virulence factors, toxin genes, BGCs associated with potentially harmful metabolites, and mobile genetic elements, as well as tailored analyses based on specific project needs. Results are delivered in dossier-ready reports aligned with current EFSA requirements for microorganisms used in the food chain.

90 %
BaseClear
1
BaseClear
1000
BaseClear
Learn more

MIC Testing for Antimicrobial Resistance Assessment

BaseClear supports MIC testing to determine antimicrobial susceptibility profiles of microbial strains. Testing is performed using standardized methods and interpreted against relevant regulatory cut-off values where available. The results support AMR risk assessment and provide clear conclusions for regulatory submissions.

90 %
BaseClear
1
BaseClear
1000
BaseClear
Learn more

Antimicrobial production Testing for Microbial Safety

BaseClear assesses whether microbial strains produce or products contain antimicrobial substances under defined test conditions. This service is performed by using appropriate indicator organisms, controls, and culture conditions to evaluate antimicrobial activity. The outcome helps determine whether antimicrobial metabolite production may require further safety consideration.

90 %
BaseClear
1
BaseClear
1000
BaseClear
Learn more

In Vitro Cytotoxicity Testing for Microbial Toxigenicity Assessment

BaseClear offers in vitro cytotoxicity testing using Vero cells to evaluate potential cytotoxic effects of microbial cultures, culture supernatants, or final product extracts. The assay is designed with defined exposure conditions, controls, and acceptance criteria to support toxicological risk assessment. Results can be integrated into a weight-of-evidence safety evaluation for regulatory submissions.

90 %
BaseClear
1
BaseClear
1000
BaseClear
Learn more

Assessment of the Presence of Viable Cells in Microbial Products

BaseClear designs and supports testing to determine the presence or absence of viable production organisms in final products. Studies are tailored to the product matrix and include appropriate enrichment, selective or non-selective culture conditions, controls, and detection limits. The results provide evidence needed to demonstrate product-level safety and regulatory compliance.

90 %
BaseClear
1
BaseClear
1000
BaseClear
Learn more

Assessment of the Presence of DNA in Final Products

BaseClear supports testing to determine the presence or absence of residual DNA, including strain-specific or recombinant DNA where relevant, in final products. The study design can include matrix-specific DNA extraction, assay controls, sensitivity assessment, and defined limits of detection. Results are reported in a format suitable for regulatory dossiers and product safety conclusions.

90 %
BaseClear
1
BaseClear
1000
BaseClear
Learn more

Regulatory Strategy & Dossier Development

We support clients across the full regulatory pathway, including gap analysis, study planning, literature review and dossier preparation for EFSA, FDA, and other authorities. Our team ensures that all data are integrated into a coherent, submission-ready package.

90 %
BaseClear
1
BaseClear
1000
BaseClear
Learn more

Taxonomic Profiling Using Amplicon & Metagenomics Sequencing

Taxonomic Profiling is a microbiome analysis service that identifies and quantifies the microorganisms present in a sample, enabling researchers to understand the composition and diversity of microbial communities. Depending on the scientific question, BaseClear offers both amplicon sequencing and shotgun metagenomics approaches to characterize bacteria, archaea, fungi, and other microorganisms across a wide range of sample types. The service provides insights into which organisms are present, their relative abundances, and how microbial communities differ between samples, treatments, environments, or time points.

 

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A Structured Approach to Microbial Regulatory Success

Three-Level Safety Framework

We structure safety assessment into strain-level, functional, and product-level evaluation, ensuring complete regulatory coverage and avoiding gaps in submissions.

Regulatory-First Study Design

All studies are designed upfront to meet EFSA and international requirements, reducing the risk of follow-up questions and delays.

RESEARCH
90%

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ARTICLES
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WEBINARS
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CASE STUDIES
5000

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ARTICLE

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WEBINAR

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CASE STUDY

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WHITEPAPER

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Frequently asked questions about AMR Risk Assessment & MIC Testing

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