Impurities in Oligonucleotide Drug Substances and Drug Products

被引：78

作者：

Capaldi, Daniel ^{[1
]}

Teasdale, Andy ^{[2
]}

Henry, Scott ^{[1
]}

Akhtar, Nadim ^{[2
]}

den Besten, Cathaline ^{[3
]}

Gao-Sheridan, Samantha ^{[4
]}

Kretschmer, Matthias ^{[4
]}

Sharpe, Neal ^{[5
]}

Andrews, Ben ^{[6
]}

Burm, Brigitte ^{[7
]}

Foy, Jeffrey ^{[8
]}

机构：

[1] Ionis Pharmaceut Inc, 2855 Gazelle Court, Carlsbad, CA 92010 USA

[2] AstraZeneca UK Ltd, Macclesfield, Cheshire, England

[3] ProQR Therapeut NV, Leiden, Netherlands

[4] Alnylam Pharmaceut Inc, Cambridge, MA USA

[5] Anavex Life Sci Corp, New York, NY USA

[6] GlaxoSmithKline, Stevenage, Herts, England

[7] ISA Therapeut, Leiden, Netherlands

[8] Celgene Corp, Summit, NJ USA

来源：

NUCLEIC ACID THERAPEUTICS | 2017年 / 27卷 / 06期

关键词：

oligonucleotides; impurities; identification; qualification; PERFORMANCE LIQUID-CHROMATOGRAPHY; CAPILLARY GEL-ELECTROPHORESIS; IONIZATION MASS-SPECTROMETRY; PHOSPHOROTHIOATE OLIGONUCLEOTIDES; INTERFERING RNA; NUCLEIC-ACIDS; THERAPEUTICS; DNA; RECOMMENDATIONS; OLIGODEOXYNUCLEOTIDES;

D O I：

10.1089/nat.2017.0691

中图分类号：

Q5 [生物化学]; Q7 [分子生物学];

学科分类号：

071010 ; 081704 ;

摘要：

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.

引用

页码：309 / 322

页数：14

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