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Grifols Delivers First Batches of COVID-19 Treatment for Clinical Trials

07/27/2020

Grifols delivered the first first manufactured batches of its anti-SARS-CoV-2 hyperimmune globulin for clinical trials. The treatment could be used for both prevention and treatment will undergo trials this summer to evaluate its safety and efficacy.  It's 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. In the past months Grifols has been collecting convalescent plasma in more than 245 Grifols U.S. donation centers from healthy recovered COVID-19 onors who have met the highest eligibility criteria

This 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 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. 

As a medicine class, hyperimmune globulins have been increasingly used since the 1970s to prevent and treat common diseases including measles, rabies and tetanus. They are also a potential therapy option in response to future outbreaks of emerging viruses and other pathogens. 

Since April, Grifols has moved quickly to collect COVID-19 convalescent plasma for its antiSARS-CoV-2 hyperimmune globulin in more than 245 Grifols 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 efforts form 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. Previous experiences, particularly that with Ebola, have enabled the company to react rapidly to the challenge. During the Ebola outbreak in Liberia in 2014, Grifols collected convalescent plasma and designed and activated a plant in Clayton, North Carolina, especially 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, coCEO 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.

Grifols is the worldwide leader in the production and distribution of immunoglobulins and hyperimmune globulins, and is firmly committed to its mission of addressing the current and future needs of patients in the world.

Grifols is a global healthcare company founded in Barcelona in 1909 working to improve the health and well-being of people around the world. Its four divisions – Bioscience, Diagnostic, Hospital and Bio Supplies – develop, produce and market solutions and services that are sold in more
than 100 countries. Grifols operates a growing network of plasmadonation centers worldwide. It transforms collected plasma into essential medicines to treat rare, chronic and, at times, life-threatening conditions. As a leader in transfusion medicine, Grifols also offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion. In addition, the company supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care. They employ more than 24,000 employees in 30 countries. 

Information courtesy: Grifols



For more information, please visit www.grifols.com

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