contractpharmaJune 16, 2020
Tag: Grifols , COVID-19 , SARS-CoV-2 , hyperimmune immunoglobulin
Grifols began 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 producing this potential anti-COVID-19 passive immune therapy as part of a collaboration agreement with the U.S. government, including the FDA, the National Institutes of Health (NIH) and the Biomedical Advanced Research Development Authority (BARDA), among other healthcare agencies. The agreement also includes 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, NC facility, which has been specifically designed to process specialty immunoglobulins.
The cas part of a clinical trial.
Grifols is proceeding 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. 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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