RESEARCH TRIANGLE PARK – Grifols, a global biotherapeutics company with more than 2,000 employees in North Carolina, will produce and test a potential COVID-19 therapy derived from the blood plasma of patients who have recovered from the coronavirus infection.
Production and testing of the therapy, hyperimmune globulin, will be expedited in a formal collaboration with the federal government. If it passes clinical trials, the therapy, which contains antibodies against COVID-19, could become the first approved treatment for the infection, Grifols said in a news release.
In addition, Grifols said it would provide support for another potential COVID-19 therapy: the use of convalescent plasma for transfusion. The company will provide its viral inactivation technology, methylene blue, to ensure safe plasma units for treatment use.
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Grifols said it would build a new facility in Clayton for the methylene blue work.
Work to begin ‘immediately’
The company did not provide a timeline for the hyperimmune globulin work but said it was ready to “immediately” begin collecting convalescent plasma and processing the product at its production facilities in Clayton.
“Working with the relevant health authorities, we will expedite the use of immune globulin from convalescent plasma in patients to ensure that it lives up to its promise as a safe and effective therapy,” said David Bell, chief innovation officer and general counsel, North America.
The project will be done in partnership with the U.S. Biomedical Advanced Research Development Authority, the Food and Drug Administration (FDA) and other federal public health agencies.
Grifols said it would volunteer its expertise and resources in plasma collection using its network of about 300 FDA-approved plasma donor centers; test and qualify donors in conjunction with health agencies; process plasma into hyperimmune globulin; and support preclinical and clinical studies.
FDA Commissioner Stephen Hahn, M.D., said during President Trump’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.”
More COVID-19 work begins in Spain
In Spain, where the company is headquartered, Grifols is working on a clinical trial with inactivated plasma from recovered COVID-19 patients through a collaboration with select donation centers and public hospitals.
In addition, the company is collaborating with various hospitals in the design of 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.
Grifols has also accelerated the development and validation of a proprietary diagnostic technology, TMA (transcription-mediated amplification). The company said TMA can detect the coronavirus with a sensitivity equivalent or even superior to that of PCR (polymerase chain reaction), a testing technology used widely for diagnosing COVID-19.
The TMA test will be performed on automatic instrumentation, with each unit able to run more than 1,000 samples per day. It will be ready “in the following weeks,” Grifols said.
Growing in Clayton
Grifols is a global healthcare company founded in Barcelona in 1909. It has more than 24,000 employees in 30 countries and regions, and its products are sold in more than 100 countries through four divisions: bioscience, diagnostic, hospital and bio supplies.
The company is known for its work in plasma-derived and transfusion medicines. It operates a network of donation centers worldwide and transforms collected plasma into medicines to treat rare, chronic and, at times, life-threatening conditions.
Plasma, the “water” portion of blood, is rich in proteins, some of which have therapeutic value. Grifols uses a process called fractionation that separates proteins so they can be purified and sterilized for use in medicines that restore or replace missing proteins.
Grifols opened a $400 million plasma-fractionation plant in Clayton in 2014 and is building a new, $90 million fractionation facility there that is scheduled to open in 2021.
The company is also building a $120 million purification and filling facility in Clayton that will mainly produce immune globulin and factor VIII protein therapies. The three-story, 150,000-square-foot facility, is scheduled to begin operating in 2022.
The expansions are making the Clayton site one of the world’s largest manufacturing plants for plasma-derived medicines. With more than 1,600 employees, the site is the largest employer in Johnston County.
Grifols also has a bioscience division headquarters facility in Research Triangle Park that employs more than 400 people.
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