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European Biopharmaceutical Review

Accessing Difficult-to- Synthesise Metabolites in Drug Development Programmes

Access to major and/or disproportionate metabolites as part of drug development programmes is critical to ensure adherence to regulatory guidelines issued by the EMA and FDA, as well as to comply with internal safety standards within pharmaceutical companies themselves (1-2).

Identification and characterisation of metabolites ensures not only rigorous safety evaluation of significant metabolites, but can also expand patent coverage and reveal superior potency, reduced side effects, or improved physical properties compared to the parent drug.

Multiple options are available for making metabolites through both chemical and biological routes, as discussed by scientists at Abbvie (3) and summarised in Figure 1.

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Julia Shanu-Wilson has over 25 years’ experience in the biotechnology and drug discovery industries. Following a BSc and PhD in microbial biochemistry at Imperial College London, UK, Julia worked in the biotech and pharma industries holding research leadership positions with Xenova, Cubist Pharmaceuticals, and TMO. She joined Hypha Discovery in 2013 and is on the management team, leading scientific communications for the company.
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Julia Shanu-Wilson
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