Journal
NUCLEIC ACID THERAPEUTICS
Volume 27, Issue 6, Pages 309-322Publisher
MARY ANN LIEBERT, INC
DOI: 10.1089/nat.2017.0691
Keywords
oligonucleotides; impurities; identification; qualification
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This white paper, which is the 10th in a series intended to address issues associated with the development of therapeutic oligonucleotides, examines the subject of product-related impurities. The authors consider chemistry and safety aspects and advance arguments in favor of platform approaches to impurity identification and qualification. Reporting, identification, and qualification thresholds suitable for product-related impurities of therapeutic oligonucleotides are proposed.
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