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 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. •Multiple companies are authorized to treat COVID-19 patients with monoclonal antibodies (mAbs).•They were discovered, developed, manufactured, tested, and approved at unprecedented speed.•Hundreds of thousands of patients around the globe benefit from these therapeutics.•CMC strategies for these mAbs may have a lasting impact on the development of future mAb therapies.