Strategies for Identity Testing of Therapeutic Oligonucleotide Drug Substances and Drug Products-Reference-Cited by-同舟云学术

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

Published:2020-10-01 Issue:5 Volume:30 Page:249-264
ISSN:2159-3337
Container-title:Nucleic Acid Therapeutics
language:en
Short-container-title:Nucleic Acid Therapeutics

Author:

Capaldi Daniel¹,Akhtar Nadim²,Atherton Tom³,Benstead David⁴,Charaf Ayman⁵,De Vijlder Thomas⁶,Heatherington Carl⁷,Hoernschemeyer Joerg⁸,Jiang Hong⁹,Rieder Ulrike¹⁰,Ring Francis¹,Peter Robert¹¹,Stolee Jessica A.⁹,Wechselberger Rainer⁶

Affiliation:

1. Development Chemistry, Ionis Pharmaceuticals Inc., Carlsbad, California, USA.

2. New Modalities and Parenteral Development and Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, United Kingdom.

3. Structure and Function Characterization, CMC Analytical, GlaxoSmithKline, Stevenage, United Kingdom.

4. Chemical Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, United Kingdom.

5. Research and Development Tides, Pharmaceutical Development Platform, Sanofi-Aventis GmbH, Frankfurt am Main, Germany.

6. Analytical Development, Small Molecule Development, Janssen Pharmaceutical Companies of Johnson and Johnson, Beerse, Belgium.

7. Drug Substance and Product Analysis UK, CMC Analytical, GlaxoSmithKline, Stevenage, United Kingdom.

8. F. Hoffmann-La Roche, Global Supplier Quality, Basel, Switzerland.

9. Analytical Development, Biogen, Cambridge, Massachusetts, USA.

10. Technical Research and Development, Global Drug Development, Novartis Pharma, Basel, Switzerland.

11. Analytical Research and Development, Synthetic Molecules Technical Development, F. Hoffmann-La Roche, Basel, Switzerland.

Publisher

Mary Ann Liebert Inc

Subject

Drug Discovery,Genetics,Molecular Biology,Molecular Medicine,Biochemistry

Link

https://www.liebertpub.com/doi/pdf/10.1089/nat.2020.0878

Reference27 articles.

1. Advances in the Synthesis of Oligonucleotides by the Phosphoramidite Approach

2. UnyLinker: An Efficient and Scaleable Synthesis of Oligonucleotides Utilizing a Universal Linker Molecule: A Novel Approach To Enhance the Purity of Drugs

3. Clinical Expert Panel on Monitoring Potential Lung Toxicity of Inhaled Oligonucleotides: Consensus Points and Recommendations

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