ArticleNucleic acid therapeutics2020
Technical Considerations for Use of Oligonucleotide Solution API.
Article in Nucleic acid therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
12 citing papers in PubMed, 36 citations in OpenAlex.
- Current CMC challenges in oligonucleotide API development: from IND to NDA.Medicinal chemistry research : an international journal for rapid communications on design and mechanisms of action of biologically active agents · 2026Review
- The use of multiple liquid chromatography methods augmented by phosphorus-31 nuclear magnetic resonance to characterize the diastereomer composition in synthetic oligonucleotides.Journal of chromatography. A · 2026Article
- Rapid and label-free isolation of human peripheral blood monocytes using a reversible CD36-binding aptamer for cell capture.Biomaterials science · 2025Article
- Engineering Considerations for Developing Next-Generation Oligonucleotide Therapeutics.Nature chemical engineering · 2024Article
- An Accurate and FastAnalytical chemistry · 2024Article
- Evolution of Vaccines Formulation to Tackle the Challenge of Anti-Microbial Resistant Pathogens.International journal of molecular sciences · 2023Review
- Considerations for the Terminal Sterilization of Oligonucleotide Drug Products.Nucleic acid therapeutics · 2023Review
- Versatility of Liposomes for Antisense Oligonucleotide Delivery: A Special Focus on Various Therapeutic Areas.Pharmaceutics · 2023Review
- Oligonucleotide Formulations Prepared by High-Speed Electrospinning: Maximizing Loading and Exploring Downstream Processability.Pharmaceutics · 2023Article
- Structural Fingerprinting of siRNA Therapeutics by Solution NMR Spectroscopy.Nucleic acid therapeutics · 2022Article
- Solution Oligonucleotide APIs: Regulatory Considerations.Therapeutic innovation & regulatory science · 2022Review
- Sustainability Challenges and Opportunities in Oligonucleotide Manufacturing.The Journal of organic chemistry · 2021Article
Corrections and comments
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Authors and funding
13 authors at 7 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The most common approach for the manufacture of oligonucleotides includes isolation of the active pharmaceutical ingredient (API) via lyophilization to provide a solid product, which is then dissolved to provide an aqueous formulation. It is well known from the development and manufacture of large molecules ("biologics") that API production does not always require isolation of solid API before drug product formulation, and this article provides technical considerations for the analogous use of oligonucleotide API in solution. The primary factor considered is solution stability, and additional factors such as viscosity, concentration, end-to-end manufacturing, microbiological control, packaging, and storage are also discussed. The technical considerations discussed in this article will aid the careful evaluation of the relative advantages and disadvantages of solution versus powder API for a given oligonucleotide drug substance.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.