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Sustainability Challenges and Opportunities in Oligonucleotide Manufacturing

[Image: see text] With a renewed and growing interest in therapeutic oligonucleotides across the pharmaceutical industry, pressure is increasing on drug developers to take more seriously the sustainability ramifications of this modality. With 12 oligonucleotide drugs reaching the market to date and...

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Autores principales: Andrews, Benjamin I., Antia, Firoz D., Brueggemeier, Shawn B., Diorazio, Louis J., Koenig, Stefan G., Kopach, Michael E., Lee, Heewon, Olbrich, Martin, Watson, Anna L.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Chemical Society 2020
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8154579/
https://www.ncbi.nlm.nih.gov/pubmed/33253568
http://dx.doi.org/10.1021/acs.joc.0c02291
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author Andrews, Benjamin I.
Antia, Firoz D.
Brueggemeier, Shawn B.
Diorazio, Louis J.
Koenig, Stefan G.
Kopach, Michael E.
Lee, Heewon
Olbrich, Martin
Watson, Anna L.
author_facet Andrews, Benjamin I.
Antia, Firoz D.
Brueggemeier, Shawn B.
Diorazio, Louis J.
Koenig, Stefan G.
Kopach, Michael E.
Lee, Heewon
Olbrich, Martin
Watson, Anna L.
author_sort Andrews, Benjamin I.
collection PubMed
description [Image: see text] With a renewed and growing interest in therapeutic oligonucleotides across the pharmaceutical industry, pressure is increasing on drug developers to take more seriously the sustainability ramifications of this modality. With 12 oligonucleotide drugs reaching the market to date and hundreds more in clinical trials and preclinical development, the current state of the art in oligonucleotide production poses a waste and cost burden to manufacturers. Legacy technologies make use of large volumes of hazardous reagents and solvents, as well as energy-intensive processes in synthesis, purification, and isolation. In 2016, the American Chemical Society (ACS) Green Chemistry Institute Pharmaceutical Roundtable (GCIPR) identified the development of greener processes for oligonucleotide Active Pharmaceutical Ingredients (APIs) as a critical unmet need. As a result, the Roundtable formed a focus team with the remit of identifying green chemistry and engineering improvements that would make oligonucleotide production more sustainable. In this Perspective, we summarize the present challenges in oligonucleotide synthesis, purification, and isolation; highlight potential solutions; and encourage synergies between academia; contract research, development and manufacturing organizations; and the pharmaceutical industry. A critical part of our assessment includes Process Mass Intensity (PMI) data from multiple companies to provide preliminary baseline metrics for current oligonucleotide manufacturing processes.
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spelling pubmed-81545792021-05-27 Sustainability Challenges and Opportunities in Oligonucleotide Manufacturing Andrews, Benjamin I. Antia, Firoz D. Brueggemeier, Shawn B. Diorazio, Louis J. Koenig, Stefan G. Kopach, Michael E. Lee, Heewon Olbrich, Martin Watson, Anna L. J Org Chem [Image: see text] With a renewed and growing interest in therapeutic oligonucleotides across the pharmaceutical industry, pressure is increasing on drug developers to take more seriously the sustainability ramifications of this modality. With 12 oligonucleotide drugs reaching the market to date and hundreds more in clinical trials and preclinical development, the current state of the art in oligonucleotide production poses a waste and cost burden to manufacturers. Legacy technologies make use of large volumes of hazardous reagents and solvents, as well as energy-intensive processes in synthesis, purification, and isolation. In 2016, the American Chemical Society (ACS) Green Chemistry Institute Pharmaceutical Roundtable (GCIPR) identified the development of greener processes for oligonucleotide Active Pharmaceutical Ingredients (APIs) as a critical unmet need. As a result, the Roundtable formed a focus team with the remit of identifying green chemistry and engineering improvements that would make oligonucleotide production more sustainable. In this Perspective, we summarize the present challenges in oligonucleotide synthesis, purification, and isolation; highlight potential solutions; and encourage synergies between academia; contract research, development and manufacturing organizations; and the pharmaceutical industry. A critical part of our assessment includes Process Mass Intensity (PMI) data from multiple companies to provide preliminary baseline metrics for current oligonucleotide manufacturing processes. American Chemical Society 2020-11-30 2021-01-01 /pmc/articles/PMC8154579/ /pubmed/33253568 http://dx.doi.org/10.1021/acs.joc.0c02291 Text en © 2020 American Chemical Society Permits non-commercial access and re-use, provided that author attribution and integrity are maintained; but does not permit creation of adaptations or other derivative works (https://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Andrews, Benjamin I.
Antia, Firoz D.
Brueggemeier, Shawn B.
Diorazio, Louis J.
Koenig, Stefan G.
Kopach, Michael E.
Lee, Heewon
Olbrich, Martin
Watson, Anna L.
Sustainability Challenges and Opportunities in Oligonucleotide Manufacturing
title Sustainability Challenges and Opportunities in Oligonucleotide Manufacturing
title_full Sustainability Challenges and Opportunities in Oligonucleotide Manufacturing
title_fullStr Sustainability Challenges and Opportunities in Oligonucleotide Manufacturing
title_full_unstemmed Sustainability Challenges and Opportunities in Oligonucleotide Manufacturing
title_short Sustainability Challenges and Opportunities in Oligonucleotide Manufacturing
title_sort sustainability challenges and opportunities in oligonucleotide manufacturing
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8154579/
https://www.ncbi.nlm.nih.gov/pubmed/33253568
http://dx.doi.org/10.1021/acs.joc.0c02291
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