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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...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier Ltd.
2022
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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 |
Sumario: | 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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