Food enzymes used in human nutrition are generally produced by microorganisms. Safety must be assessed before the enzymes can be offered to the market. The application submitted to the regulatory agencies (EFSA and/or FDA) in support of the enzyme should include a detailed characterisation and safety assessment of the production organism. Applying the regulatory guidelines and rules to the genomic data generated when analysing the microbial strains often presents both technical and interpretation challenges.

BaseClear can be of service for all steps needed in the process, whether early-stage research or seeking approval for an already developed food enzyme. BaseClear has a number of PhD-level scientist ready to take up on the next challenge. In addition, we have an extensive network of partners and collaborators on the Leiden Bio Science Park – the leading biomedical hotspot of Europe. With this we can offer our client an all-inclusive package, planning and performing of the studies required.

BaseClear services for food enzyme safety assessment

  • Clear reports for dossier filing to regulatory agencies
  • 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
  • Metagenomics analysis
  • Identification of microbes (bacteria, yeasts, filamentous fungi)
  • Whole genome sequencing (WGS), including genome assembly and annotation
  • Analysis of the presence of toxin genes and virulence factors
  • Analysis of the presence of antibiotic resistance genes
  • Analysis of genetic modifications
  • Assessment of genetic stability
  • Analysis of the absence of the production organism and residual DNA in the final product
  • Tailored bioinformatics for your specific needs
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Meet Adalberto Costessi!

Adalberto is our Product Managers Genomics & Regulatory Affairs. Adalberto graduated in Medical Biotechnology at the University of Trieste. He specialised in molecular biology and next-generation sequencing during his PhD at the Radboud University in Nijmegen, where he studied the transcriptonal mechanisms of cancer cells. Adalberto is BaseClear’s technical expert on short and long read NGS platforms, including the latest nanopore-based technologies, and how to best use them for specific applications.

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