CLAYTON – Grifols, a global leader in the development of therapies with plasma-derived proteins, today announced it has delivered the first manufactured batches of its anti-SARS-CoV-2 hyperimmune globulin for clinical trials.
Since April, Grifols began collecting COVID-19 convalescent plasma for its anti-SARS-CoV-2 hyperimmune globulin in more than 245 U.S. donation centers from donors who have met the highest eligibility criteria. Their plasma, rigorously tested and quality controlled, had high levels of anti-SARS-CoV-2 neutralizing antibodies.
The medicine specifically targets SARS-CoV-2 by providing passive immunity to infected patients and boosting their immune system’s ability to fight the disease. The therapy, which could be used for both prevention and immediate treatment of COVID-19, will undergo clinical trials this summer to test its safety and efficacy.
The treatment is 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 anti-SARS-CoV-2 hyperimmune globulin, which is derived from the blood plasma of healthy donors recovered from COVID-19, has the potential to be a highly specific, pure and safe medicine that delivers a high and consistent concentration of protective antibodies against the novel coronavirus.
A Grifols spokesman told NSJ, “Our Clayton plant is equipped and staffed with personnel specialized in the production of plasma-derived medicines for infectious diseases/viruses.”
Hyperimmune globulins have been increasingly used since the 1970s to prevent and treat common diseases including measles, rabies and tetanus.
During the Ebola outbreak in Liberia in 2014, Grifols collected convalescent plasma and designed and activated a plant in Clayton equipped and staffed with personnel specialized in the production of plasma-derived medicines for infectious diseases.
“Grifols is grateful to all the plasma donors who through their generosity are now helping to develop a medicine, a hyperimmune globulin, whose concentrated antibodies will potentially provide others with passive immunity to overcome the disease,” said Victor Grifols Deu, co-CEO of Grifols.
Added Grifols co-CEO Raimon Grifols Roura: “All of us at Grifols are proud to devote our time, talent and energies to fight this health crisis.”
In addition to clinical trials in the U.S., Grifols is working on a European clinical trial of a hyperimmune globulin using convalescent plasma collected in Europe.
