Grifols, a global healthcare company with a track record of more than 100 years and a recognized leader in the development and production of plasma-derived medicines, is identifying, screening and selecting volunteer donors who have recovered from COVID-19 to donate their plasma at the Grifols Biomat USA center in Panama City.
The plasma will be used to produce an anti-SARS-CoV-2 hyperimmune globulin that, if proven effective, could potentially treat the disease. Grifols has already begun producing a hyperimmune globulin, delivering its first manufactured batches for clinical trials in July. This initiative is a result of a collaboration between Grifols, the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH), the U.S. Biomedical Advanced Research Authority (BARDA), and other Federal health agencies.
Hyperimmune globulins are plasma derived-medicines that are effective in the treatment of severe acute infections. Through the concentration of antibodies from plasma collected from recovered COVID-19 individuals, the hyperimmune globulin can offer precise and consistent dosing with high purity, high potency and a strong safety profile that may help current patients’ immune systems respond to the infection.
Grifols has decades of experience partnering with its thousands of regular plasma donors across the country through its industry-leading network of more than 250 FDA-approved centers dedicated to collecting plasma. The company specifically designed and constructed a building in Clayton, N.C., for the processing of immune globulins to treat emerging infectious diseases that was already used during the last Ebola outbreak in Liberia. Thanks to that experience, Grifols acquired knowledge and expertise that today will help to expedite the product rapidly to clinical trial.
“For individuals who have recovered from COVID-19, donating plasma at one of Grifols’ donor centers to produce a potential treatment for the disease is a way they can help make a difference during this exceptional time,” said Dr. Marilyn Rosa-Bray, Grifols Chief Medical Officer and Vice President Quality, Regulatory Compliance & Laboratories. “This hyperimmune globulin would offer treating physicians a predictable and consistent dosing of the antibody against the virus that causes COVID-19.”
Grifols is acting with urgency in this global crisis and volunteering its expertise and resources to the project. The resulting anti-SARS-CoV-2 hyperimmune globulin will undergo controlled clinical trials with the NIH to evaluate its safety and efficacy as a viable treatment for COVID-19.
Grifols is collecting convalescent plasma from potential donors in more than 100 cities across the country that have had a high number of COVID-19 cases, including Panama City.
Recovered COVID-19 individuals interested in donating should call 1-866-END-CV19 where trained Grifols specialists will prescreen potential donors and direct them to their local Grifols plasma donor center. Interested donors must have a diagnosis made with a test (nasal swab or blood) and complete resolution of COVID-19 symptoms at least 28 days prior to donation, or complete resolution of symptoms at least 14 days prior to donation along with a negative molecular test for COVID-19, as well as meet our routine eligibility criteria for normal source plasma donation. To learn more visit www.grifolsplasma.com.
