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COUNTERPHARM Résumé de rapport

Project ID: G6RD-CT-2002-00849
Financé au titre de: FP5-GROWTH
Pays: United Kingdom

"Tagging" a biotransformation process by introduction of specific markers as a means of protection from counterfeit products

As reported under result 17887, isotopic techniques can be used to prove whether or not a given molecule of pharmaceutical importance has been produced by a specified patented process. They can be applied in conjunction with impurity profiling by chromatographic methodologies (results 17888 and 17889) to provide a combined patent-infringement and anti-counterfeiting detection strategy. However, particular challenges may arise in the case of biotechnological products and processes, where synthetic routes may be isotopically indistinguishable if the producing organisms share the same or closely similar biosynthetic pathways, and where impurity profiles reflect the origins both of the feedstock(s) and of other components of the culture media, as well as the characteristics of the producing organisms themselves, leading to unpredictable variability in overall impurity profiles. Using vanillin as a model compound, we have developed a solution to this problem that makes use of naturally occurring, metabolisable analogues of the feedstock for vanillin production (ferulic acid) that can be introduced into the feedstock in defined, small quantities. These metabolisable analogues are then converted during the biotechnological process to analogues of vanillin that are detectable in the final product. Thus a process can be individually and specifically "tagged" with metabolisable analogues that may be incorporated at predetermined levels (and which may be varied at will), leading to an unequivocal identification of the products of a specific process.

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Norwich Research Park, Colney
United Kingdom
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