BARCELONA, Spain/CLAYTON, N.C. – Grifols, a pioneer in the plasma industry, has announced a formal collaboration with the United States Biomedical Advanced Research Development Authority (BARDA), the Food and Drug Administration (FDA) and other Federal public health agencies to collect plasma from convalescent, or recovering, COVID-19 patients. The process is designed to develop this specific plasma into a therapeutic immunity component and support the necessary preclinical and clinical studies to determine if the “anti-SARS-CoV-2 hyperimmune globulin therapy” can successfully be used to treat COVID-19 disease.
In a press statement, Grifols officials indicated that the company will volunteer its expertise and resources in the areas of plasma collection using its network of FDA-approved plasma donor centers; test and qualify donors in conjunction with other health agencies; process plasma into hyperimmune globulin in its purpose-built facility in Clayton, North Carolina, for the isolated processing of immune globulins to treat emerging infectious diseases; and support preclinical and clinical studies to determine whether hyperimmune globulin made from the plasma of convalescent donors can live up to its promise as a viable treatment for COVID-19 disease and as a platform for the treatment of future emerging infectious diseases.
According to Grifols, the Clayton facility is the world’s largest plasma manufacturing plant.
Officials say this innovative public-private partnership presents opportunities to expedite development and, if successful, availability of a front-line therapeutic in the face of the spreading COVID-19 pandemic. The FDA is specifically working to reduce unnecessary regulatory hurdles and ensure a rapid turnaround without compromise to product safety or integrity.
As indicated by FDA Commissioner Stephen Hahn, M.D., during the President’s March 19 Coronavirus Task Force briefing, “There is a cross agency effort about…convalescent plasma. This is an exciting area…If you’ve been exposed to coronavirus and you are better…we could collect the [plasma], concentrate that…to be able to give that to other patients. The immune response could provide a benefit to patients.”
In addition to the development of a hyperimmune globulin as a therapy for COVID-19, Grifols is also providing support to utilize convalescent plasma for transfusion as a potential therapy by providing viral inactivation technology (methylene blue) to ensure inactivated plasma units for treatment use. (Grifols will be building a new facility in the Clayton site for this purpose.)
As leaders in the transfusion industry, Grifols, founded in Barcelona in 1909, operates a growing network of donation centers worldwide. It transforms collected plasma into essential medicines to treat rare, chronic and, at times, life-threatening conditions.
In the news release, Grifols officials said, “We believe this current and extraordinary situation requires companies to strive more than ever to serve patients and society around the world and is proud to be working with the United States Public Health Agencies and personnel to combat COVID-19 disease.”
“This unique collaboration will provide the opportunity to validate a therapy that, if proven effective, can be used today in the face of the COVID-19 pandemic and for future outbreaks of novel emerging viruses.”
At the same time, in Spain, Grifols is working on a clinical trial with inactivated plasma from recovered patients (methylene blue) through a collaboration with select donation centers and public hospitals since, unlike in the U.S., in Spain there are no Grifols-owned plasma donation centers. In addition, the company is collaborating with certain hospitals in the design of diverse clinical studies on the use of certain plasma-derived products, such as intravenous immunoglobulin and alpha-1 antitrypsin, with the goal of proving their efficacy in the treatment of COVID-19.
In addition, Grifols says it has accelerated the development and validation of a proprietary technology TMA (transcription-mediated amplification) based diagnostic procedure, able to detect the virus with a sensitivity equivalent or even superior to that of PCR (polymerase chain reaction). The test will be performed on automatic instrumentation, with each unit able to run more than 1,000 samples per day, and that will be ready in the following weeks.