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Monoclonal antibody therapies for COVID-19: lessons learned and implications for the development of future products()

Several companies were authorized to treat COVID-19 patients with monoclonal antibodies within 1–2 years of the start of the pandemic. These products were discovered, developed, manufactured, clinically tested, and approved under emergency-use authorization at unprecedented speed. Pandemic urgency l...

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Detalles Bibliográficos
Autores principales: Kelley, Brian, De Moor, Pam, Douglas, Kristen, Renshaw, Todd, Traviglia, Stacey
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier Ltd. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9436891/
https://www.ncbi.nlm.nih.gov/pubmed/36179406
http://dx.doi.org/10.1016/j.copbio.2022.102798
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author Kelley, Brian
De Moor, Pam
Douglas, Kristen
Renshaw, Todd
Traviglia, Stacey
author_facet Kelley, Brian
De Moor, Pam
Douglas, Kristen
Renshaw, Todd
Traviglia, Stacey
author_sort Kelley, Brian
collection PubMed
description Several companies were authorized to treat COVID-19 patients with monoclonal antibodies within 1–2 years of the start of the pandemic. These products were discovered, developed, manufactured, clinically tested, and approved under emergency-use authorization at unprecedented speed. Pandemic urgency led to novel development approaches that reduced the time to clinical trials by 75% or more without creating unacceptable patient or product-safety risks. Hundreds of thousands of patients now benefit from these therapeutics that have reduced the rates of hospitalization and death. The chemistry, manufacturing, and control development strategies set a new precedent of speed, safety, and demonstrated clinical benefit and will likely have a lasting impact on the development of future monoclonal antibody therapies for not only infectious diseases but also for oncology, inflammation, and rare diseases.
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spelling pubmed-94368912022-09-02 Monoclonal antibody therapies for COVID-19: lessons learned and implications for the development of future products() Kelley, Brian De Moor, Pam Douglas, Kristen Renshaw, Todd Traviglia, Stacey Curr Opin Biotechnol Article Several companies were authorized to treat COVID-19 patients with monoclonal antibodies within 1–2 years of the start of the pandemic. These products were discovered, developed, manufactured, clinically tested, and approved under emergency-use authorization at unprecedented speed. Pandemic urgency led to novel development approaches that reduced the time to clinical trials by 75% or more without creating unacceptable patient or product-safety risks. Hundreds of thousands of patients now benefit from these therapeutics that have reduced the rates of hospitalization and death. The chemistry, manufacturing, and control development strategies set a new precedent of speed, safety, and demonstrated clinical benefit and will likely have a lasting impact on the development of future monoclonal antibody therapies for not only infectious diseases but also for oncology, inflammation, and rare diseases. Elsevier Ltd. 2022-12 2022-09-02 /pmc/articles/PMC9436891/ /pubmed/36179406 http://dx.doi.org/10.1016/j.copbio.2022.102798 Text en © 2022 Elsevier Ltd. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Article
Kelley, Brian
De Moor, Pam
Douglas, Kristen
Renshaw, Todd
Traviglia, Stacey
Monoclonal antibody therapies for COVID-19: lessons learned and implications for the development of future products()
title Monoclonal antibody therapies for COVID-19: lessons learned and implications for the development of future products()
title_full Monoclonal antibody therapies for COVID-19: lessons learned and implications for the development of future products()
title_fullStr Monoclonal antibody therapies for COVID-19: lessons learned and implications for the development of future products()
title_full_unstemmed Monoclonal antibody therapies for COVID-19: lessons learned and implications for the development of future products()
title_short Monoclonal antibody therapies for COVID-19: lessons learned and implications for the development of future products()
title_sort monoclonal antibody therapies for covid-19: lessons learned and implications for the development of future products()
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9436891/
https://www.ncbi.nlm.nih.gov/pubmed/36179406
http://dx.doi.org/10.1016/j.copbio.2022.102798
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