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

共 50 条

[21] PHOTOSTABILITY TESTING OF DRUG SUBSTANCES AND DRUG PRODUCTS IN UK PHARMACEUTICAL LABORATORIES
ANDERSON, NH
JOHNSTON, D
MCLELLAND, MA
MUNDEN, P
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 1991, 9 (06) : 443 - 449
[22] Regulatory Submission Templates for Elemental Impurities, Genotoxic Impurities, and Nitrosamine Impurities of Pharmaceutical Drug Substances
Nilesh, Patil
Sandeep, Patel
Dave, Hiral
ASIAN JOURNAL OF PHARMACEUTICAL RESEARCH AND HEALTH CARE, 2024, 16 (04) : 366 - 377
[23] Strategies for validated quantification of protein drug substances and protein impurities
Aschermann, Katja
Wattenberg, Andreas
PHARMAZEUTISCHE INDUSTRIE, 2008, 70 (04): : 535 - 540
[24] Nitrosodimethylamine impurities in metformin drug products: Physician insight
Doshi, Chetan
Malayandi, Rajkumar
Namjoshi, Gajanan
Kadam, Pramod
Mule, Dhananjay
JOURNAL OF DIABETOLOGY, 2021, 12 (02) : 120 - 127
[25] Excipient-related impurities in liposome drug products
Wang, Changguang
Gamage, Prabhath L.
Jiang, Wenlei
Mudalige, Thilak
INTERNATIONAL JOURNAL OF PHARMACEUTICS, 2024, 657
[26] The Role of Separation Techniques in the Analysis of mRNA Therapeutic Drug Substances and Drug Products
Vanhinsbergh, Christina
LCGC EUROPE, 2023, 36 (02) : 42 - 50
[27] THE VALIDATION OF ANALYTICAL METHODS FOR DRUG SUBSTANCES AND DRUG PRODUCTS IN UK PHARMACEUTICAL LABORATORIES
CLARKE, GS
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 1994, 12 (05) : 643 - 652
[28] DRUG IMPURITIES
不详
BRITISH JOURNAL OF ANAESTHESIA, 1965, 37 (10) : 715 - &
[29] Strategies for the investigation and control of process-related impurities in drug substances
Argentine, Mark D.
Owens, Paul K.
Olsen, Bernard A.
ADVANCED DRUG DELIVERY REVIEWS, 2007, 59 (01) : 12 - 28
[30] Detection of host cell microprotein impurities in antibody drug products
Tzani, Ioanna
Castro-Rivadeneyra, Marina
Kelly, Paul
Strasser, Lisa
Zhang, Lin
Clynes, Martin
Karger, Barry L.
Barron, Niall
Bones, Jonathan
Clarke, Colin
NATURE COMMUNICATIONS, 2024, 15 (01)

← 1 2 3 4 5 →