Microbial strain assessment

For nutrition or health claims, the Food Safety Authority (EFSA or FDA) requires full knowledge of the organism you are working with. BaseClear can facilitate this with a complete solution including consultancy and genomic data analyses as required by EFSA and/or FDA.

BaseClear offers significant expertise and years of experience in the requirements of dossier filing to regulatory agencies. The PhD-level experts at BaseClear have a unique combination of strong background in regulatory affairs, microbiology and molecular biology and understand what it takes to submit applications to EFSA or FDA agencies.

BaseClear can help you from the start, e.g. with the identification of the bacterial strain and provide you with a complete genome characterisation. BaseClear provides you with information about the location of the antibiotic resistance (chromosome or plasmid), identification of the antibiotic resistance genes as well as identification of mobile genetic elements that may promote transfer of genomic regions coding for the antibiotic resistance to other organisms. Ultimately, this information is vital to justify why your bacterial strains may be used as a feed or food additive.

BaseClear services for microbial strain assessment

  • Helping in getting data in the form required by the food enzyme safety authorities
  • Data analyses, interpretation of results (e.g. from WGS) and conclusions
  • Literature reviews, consultations and statements
  • Complete genome based strain characterisation as required for EFSA or FDA claims
  • Metagenomics analysis
  • Unique antibiotic resistance gene screening
  • Plasmid detection and identification services
  • Production strain analysis including copy number and gene expression analysis
  • Fungal production strain analysis and annotation
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Experts meeting on strain characterisation for regulatory approval

BaseClear has many years of expertise in microbial strain characterisation, including the requirements needed for regulatory approval (e.g. EFSA and FDA). We routinely organise expert meetings wherein scientists and researchers meet, share and discuss applications and technical challenges.

Our experts meetings
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