Probing Deep Understanding of an LC-UV-MS Method for Characterising Oligonucleotides

When a multinational pharmaceutical manufacturer wanted to get to a deep understanding of a strategically important analytical method to inform improved training and method standardisation, the Britest methodology was used to complement established methods of Analytical Risk Assessment. A tailored DuDES analysis identified opportunities to remove subjectivity from the method, leading to harmonisation across departments and external partners, identification of actions to improve training materials and the internal standardised method, and consequential benefits for in-country testing.

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