Recent approvals of oligonucleotide therapeutics are a clear signal for optimism for this product class. This is supported by the strength of the current pipeline which has over 180 active oligonucleotide clinical programs in various phases of development. Improvements in analytical technology and know-how have played a key role in enabling suitable characterization and quality control strategies to overcome the difficulties associated with testing these complex molecules. Despite the lack of dedicated regulatory guidelines related to characterization or quality control, there is sufficient prior knowledge within the biopharmaceutical industry to both appreciate the complexity and design of the required analytical programs and to provide guidance in the definition of key quality attributes.

In this article, Analytical Challenges: Characterization of Oligonucleotide Therapeutics, Intertek’s experts share their insight into key considerations for the design of these analytical programs and relevant analytical approaches with case studies focusing on identification testing by accurate intact mass and tandem mass spectrometry sequencing and the application of ion-pair HPLC for identification, assay, and impurities characterization. Download now to learn more.

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