Analytical Challenges in the Characterisation of Therapeutic Oligonucleotides

Analytical characterisation as well as establishing a strategic quality control program to support oligonucleotide therapeutic product development, regulatory approval and to ensure continued safety and efficacy is fundamental to the success of both individual products as well as to realise the potential this class of molecules offers as a therapeutic agents. The complexity of structure and relative infancy of this product class requires careful scientific consideration when designing such programs to ensure analytical programs meet the requirements for first class quality control. This article discusses the design of such programs as well as providing insight into learnings around experimental design and the use of orthogonal approaches. 

Author: Ashleigh Wake, Site Director, Intertek Pharmaceutical Services, Manchester (UK)

Originally published in Edition 6 (Nov/Dec) 2018 of Chimica Oggi – Chemistry Today

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