Impurities in Oligonucleotide Drug Substances and Drug Products

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 i...

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Published inNucleic acid therapeutics Vol. 27; no. 6; pp. 39 - 322
Main Authors Capaldi, Daniel, Teasdale, Andy, Henry, Scott, Akhtar, Nadim, den Besten, Cathaline, Gao-Sheridan, Samantha, Kretschmer, Matthias, Sharpe, Neal, Andrews, Ben, Burm, Brigitte, Foy, Jeffrey
Format Journal Article
LanguageEnglish
Published United States Mary Ann Liebert, Inc 01.12.2017
Subjects
Animals
Chemistry
Chemistry Techniques, Analytical - methods
Chemistry, Pharmaceutical - methods
Chromatography
Drug Contamination - prevention & control
Drug Design
Drug Industry - standards
Female
Humans
Impurities
Issues in Development
Limit of Detection
Male
Mass spectrometry
Mice
Models, Animal
Oligonucleotides
Oligonucleotides - analysis
Oligonucleotides - chemical synthesis
Oligonucleotides - therapeutic use
Patient Safety - standards
Pharmaceuticals
Product safety
Scientific imaging
qualification
identification
oligonucleotides
impurities
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Summary: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.
Bibliography:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ISSN:2159-3337
2159-3345
DOI:10.1089/nat.2017.0691