Perspectives on the Designation of Oligonucleotide Starting Materials-Reference-Cited by-同舟云学术

Perspectives on the Designation of Oligonucleotide Starting Materials

Published:2021-04-01 Issue:2 Volume:31 Page:93-113
ISSN:2159-3337
Container-title:Nucleic Acid Therapeutics
language:en
Short-container-title:Nucleic Acid Therapeutics

Author:

Kiesman William F.¹,McPherson Andrew K.²,Diorazio Louis J.³,Van den Bergh Leo⁴,Smith Peter D.⁵,Northall John M.⁶,Fettes Alec⁷,Wang Tiejun⁸,Mehlmann Martin⁹,Raza Syed¹⁰,Held Gary¹¹

Affiliation:

1. Antisense Oligonucleotide Development and Manufacturing, Biogen, Inc., Cambridge, Massachusetts, USA.

2. Process Organic Chemistry, Ionis Pharmaceuticals, Inc., Carlsbad, California, USA.

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

4. API Small Molecule Development, Janssen, Beerse, Belgium.

5. Early Chemical Development, Pharmaceutical Sciences, R&D, AstraZeneca, Macclesfield, United Kingdom.

6. Chemical Development, Product Development and Supply, GlaxoSmithKline, Stevenage, United Kingdom.

7. Pharmaceutical Division, Small Molecule Technical Development, Department of Process Chemistry and Catalysis, F. Hoffmann-La Roche Ltd., Basel, Switzerland.

8. Global Regulatory Affairs, CMC & Devices, Sanofi, Bridgewater, New Jersey, USA.

9. External Technical Oversight Analytics, F. Hoffmann-La Roche Ltd., Basel, Switzerland.

10. Amidite Manufacturing and Process Development, Thermo Fisher Scientific, Milwaukee, Wisconsin, USA.

11. Amidite Quality Control and Analytical Development, Thermo Fisher Scientific, Milwaukee, Wisconsin, USA.

Publisher

Mary Ann Liebert Inc

Subject

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

Link

https://www.liebertpub.com/doi/pdf/10.1089/nat.2020.0909

Reference46 articles.

1. Part 3: Designation and Justification of API Starting Materials: Proposed Framework for Alignment from an Industry Perspective

2. European Pharma Oligonucleotide Consortium A Move to Consolidate Oligonucleotide Knowledge and Share Experience Within the Community

3. Technical Considerations for Use of Oligonucleotide Solution API

4. Impurities in Oligonucleotide Drug Substances and Drug Products

5. Polymer support oligonucleotide synthesis XVIII1.2): use ofβ-cyanoethyi-N,N-dialkylamino-/N-morpholino phosphoramidite of deoxynucleosides for the synthesis of DNA fragments simplifying deprotection and isolation of the final product

Cited by 13 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. A Review on Commercial Oligonucleotide Drug Products;Journal of Pharmaceutical Sciences;2024-07

2. Improvement of oligonucleotide separation using a repetto high‐performance liquid chromatography recycling approach;Journal of Separation Science;2024-05-31

3. Synthesis of a Hydrophobic Phenanthrene‐Containing Universal Support for Solid‐Phase Oligonucleotide Synthesis;Current Protocols;2024-03

4. Separation and purification of short-, medium-, and long-stranded RNAs by RP-HPLC using different mobile phases and C₁₈ columns with various pore sizes;Analytical Methods;2024

5. Platform Strategies for Synthetic Oligonucleotide Drug Substances;Organic Process Research & Development;2023-11-30