Drug and Environmental Fate (eFate) Metabolites

We mimic mammalian phase I and phase II metabolism using our talented microorganism panels to produce metabolites for unambiguous identification, use as quantitation standards or larger amounts for DMPK/ADME/TOX studies and to satisfy the FDA’s MIST guidelines. Metabolites arising from a variety of processes are accessible, including both CYP and non-CYP derived mechanisms. We can also produce phase II conjugates such as N-, O- and acyl glucuronides and sulfated metabolites.

References 1) Smith & Rosazza, Arch. Biochem Biophys. (1974) 161: 551-558. 2) Azerad, R., Adv Biochem Eng Biotechnol (1999) 63, 169.

Microbial biotransformation will produce most mammalian metabolites as it is well-established that microbial organisms mimic mammalian metabolism of small molecules1, 2 due to evolutionarily-related enzyme systems. We have been able to demonstrate that our biotransformation panel are able to undertake these common reactions, amongst many others.

References
1) Smith & Rosazza, Arch. Biochem Biophys. (1974) 161: 551-558.
2) Azerad, R., Adv Biochem Eng Biotechnol (1999) 63, 169.

Key features:

  • Phase I metabolites produced from both CYP and non-CYP mediated pathways
  • Production of Phase II conjugates, including N-,O- & acyl glucuronide and sulfated metabolites
  • Multiple metabolites can be captured in a single screen
  • Reproducible and scalable process up to gram quantities
  • Provides a tool for MetID
  • Target molecules can be produced at mg/g quantities for pharmacology/toxicology and to satisfy MIST guidelines
  • Applicable to broad structural types and complex molecules, including natural products and synthetic compounds
  • Formulation know-how for poorly-soluble compounds
  • Provides a solution for synthetically challenging metabolites when synthesis is not possible or too costly / time-consuming
  • Metabolites are produced on a simple fee-for-service basis, i.e. there are no downstream terms or royalties

 

Metabolite match rate 87%
Scale-up reproducibility rate 97%

 

 

Hypha’s biotransformation platform is also effective for the production of environmental fate derivatives of agrochemicals. Our processes have been specially adapted to accept and metabolise pesticides which typically have poor aqueous solubility.

Contact Us to discuss how we can help your project succeed

 

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