After announcing that the United States considered it “basic infrastructure” during the coronavirus health emergency, Grifols has signed a multilateral collaboration agreement in that country. The accord is with the U.S. Advanced Biomedical Research and Development Authority (BARDA), the U.S. Food and Drug Administration (FDA) and other federal public health agencies. The objective will be to collect plasma from patients who have recovered from Covid-19, process it and produce hyperimmune immunoglobulins.
The agreement also includes collaboration on the development of preclinical and clinical studies. These are necessary in order to determine the effectiveness of antiSARS-CoV-2 hyperimmune immunoglobulin therapy in treating Covid-19 and other infectious disease outbreaks. Grifols will voluntarily provide its current resources, in addition to its extensive knowledge and experience in the areas of plasma collection and purification.
The Spanish healthcare firm will also make its network of FDA-approved donation centers available for the project. They will examine and identify donors, together with other US health agencies. Then the plasma will be processed to produce the hyperimmune immunoglobulins at its specially designed and isolated facilities for infectious diseases in Clayton (North Carolina).
In addition to the development of hyperimmune immunoglobulins, Grifols has also offered its knowledge and experience for the potential treatment of Covid-19 with direct transfusions of plasma from patients recovered from the infection. Grifols is also accelerating the development and validation of a diagnostic method based on proprietary TMA (transcription-mediated amplification) technology. This is capable of detecting the virus with a sensitivity equivalent to or even higher than that of PCR (polymerase chain reaction)-based techniques.