Characterisation of microorganisms for regulatory approval

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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BaseClear strain characterisation

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

Meet Adalberto Costessi!

Adalberto Costessi enjoys working on the interface between technology and its application in his position as Product Manager Genomics and Regulatory Affairs. Adalberto’s roles and responsibilities include Regulatory Affairs projects, and shaping and developing new products using NGS sequencing platforms. His work in Regulatory Affairs has assisted many multinational clients in the food and feed industries draft dossier submissions for regulatory approval and has built up considerable experience in this area. He ensures that the generation of genomics and bioinformatics data are compliant with regulatory requirements and are suitable for supporting dossier preparation for new products based on microbial strains introduced intentionally into the food chain. He has extensive expertise in the technology side of genomics and brings a lot of technical knowledge into his position.

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