Strategies for Identity Testing of Therapeutic Oligonucleotide Drug Substances and Drug Products

A risk-based approach for routine identity testing of therapeutic oligonucleotide drug substances and drug products is described. Risk analysis of solid-phase oligonucleotide synthesis indicates that intact mass measurement is a powerful technique for confirming synthesis of the intended oligonucleo...

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Veröffentlicht in:	Nucleic acid therapeutics 2020-10, Vol.30 (5), p.249-264
Hauptverfasser:	Capaldi, Daniel, Akhtar, Nadim, Atherton, Tom, Benstead, David, Charaf, Ayman, De Vijlder, Thomas, Heatherington, Carl, Hoernschemeyer, Joerg, Jiang, Hong, Rieder, Ulrike, Ring, Francis, Peter, Robert, Stolee, Jessica A, Wechselberger, Rainer
Format:	Artikel
Sprache:	eng
Schlagworte:	Issues in Development Oligonucleotides Product differentiation Risk analysis Risk assessment Risk communication Sensitivity analysis Solid phases Synthesis
Online-Zugang:	Volltext
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