Sotrovimab Slow Production Delays Omicron-Effective Treatments
The Wall Street Journal reported on January 22, 2022, GSK and Vir Biotechnology are increasing the output of their leading monoclonal antibody (mAbs), sotrovimab. In addition, the Journal stated a second plant is coming online to help meet the overwhelming COVID-19 patient demand.
And, Fierce Pharma reported the U.S. FDA cleared a Samsung Biologics site on December 30, 2021, as a second sotrovimab manufacturing facility to make.
As part of its growth plan in 2022, Samsung Biologics stated on January 12 it is planning a new facility, Plant 5, where it will offer multi-modal products including cell & gene therapies and next-gen vaccines utilizing mRNA pDNA, and viral vectors, all at a single site.
This site will be added to the mRNA vaccine drug substance manufacturing suite the company is currently adding to its existing facility in Songdo, South Korea, which is expected to be ready for operations in early 2022.
GSK and Vir expect to manufacture about 2 million mAbs doses globally in the first half of 2022.
However, during the week of January 17, 2022, only 52,064 sotrovimab doses were distributed in the U.S.
On May 26, 2021, GlaxoSmithKline LLC received Emergency Use Authorization from the FDA. And Europe authorized Xevudy (Sotrovimab) on December 17, 2021.
Sotrovimab is a fully human anti-SARS-CoV-2 mAbs selected based on its potential to neutralize coronavirus in vitro, kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs.
As of January 23, 2022, the U.S. NIH's OpenData Portal indicates sotrovimab is very effective against the SARS-CoV-2 virus variant known as Omicron.