Grifols announced the start of production of its anti-SARS-CoV-2 hyperimmune immunoglobulin with specific antibodies using the plasma of people who have overcome the disease. It is the first specific drug developed to combat COVID-19.
Grifols is leading the production of this potential anti-COVID-19 passive immune therapy as part of a collaboration agreement with U.S. government entities, including the Food and Drug Administration (FDA), the National Institutes of Health (NIH) and the Biomedical Advanced Research Development Authority (BARDA), among other healthcare agencies. The agreement also encompasses the development of preclinical and clinical trials required to determine treatment efficacy. The company is also moving forward to establish collaborations in Europe.
Grifols’ anti-SARS-CoV-2 hyperimmune immunoglobulins are being produced in its Clayton (North Carolina, U.S.) facility, which has been specifically designed to process specialty immunoglobulins.
The first doses are expected to be available in July 2020 as part of a clinical trial.
Grifols leverages its broad expertise and experience in previous healthcare emergencies like the Ebola outbreak to become the first company to start production of an anti-SARS-CoV-2 hyperimmune immunoglobulin.
At the same time, Grifols is moving forward with its clinical trial in Spain to assess the effectiveness of high-dose intravenous immunoglobulin to stabilize or improve the condition of COVID-19 patients.
In this regard, the trial aims to assess the action of neutralizing antibodies (proteins that bind viruses and prevent them from infecting human cells), as well as determine the immunomodulatory potential (immune modulation response) of immunoglobulins as therapy to block the cytokine storm in patients with severe cases of COVID-19.
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