Kun FDA valtuutti plasman torjumaan COVID-19:ää, Claytonin tehdas työskentelee mahdollisen hoidon parissa

CLAYTON – President Donald Trump announced emergency authorization to treat COVID-19 patients with convalescent plasma — a move he called “a breakthrough,” one of his top health officials called “promising” and other health experts said needs more study before it’s celebrated. And that news could be good for Grifols, which operates a huge plasma production plant in Clayton.

The announcement Sunday came after White House officials complained there were politically motivated delays by the Food and Drug Administration in approving a vaccine and therapeutics for the disease.

On the eve of the Republican National Convention starting in Charlotte, Trump put himself at the center of the FDA’s announcement of the authorization at a news conference Sunday evening. The authorization makes it easier for some patients to obtain the treatment but is not the same as full FDA approval.

But what might be the impact in Clayton?

“No statement, other than the news that we’ve been working on an anti-SARS-CoV-2 hyperimmune globulin at our Clayton plant for clinical trials,” a Grifols spokesperson told WRAL-TechWire.

“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.”

Production was announced earlier this month, and Grifols has delivered the first batches of a therapeutic product manufactured in Clayton.

Huhtikuusta lähtien Grifols on kerännyt COVID-19:stä toipuneiden terveiden ihmisten luovuttamaa veriplasmaa. Yhtiön yli 245 Yhdysvaltain luovutuskeskuksesta kerätystä plasmasta prosessoidaan hyperimmuuniglobuliini, liuos, joka sisältää suojaavia vasta-aineita uutta koronavirusta vastaan.

"Grifols on kiitollinen kaikille plasmanluovuttajille, jotka anteliaisuuttaan auttavat nyt kehittämään lääkettä, hyperimmuuniglobuliinia, jonka tiivistetyt vasta-aineet voivat tarjota muille passiivisen immuniteetin taudin voittamiseksi", sanoi Victor Grifols Deu, toimitusjohtaja. Grifolsin upseeri.

Pyrkimykset ovat osa yhteistyösopimusta Yhdysvaltojen hallituksen tahojen kanssa, mukaan lukien Food and Drug Administration, National Institutes of Health ja Biomedical Advanced Research Development Authority.

(NCBiotech writer Barry Teater contributed to this story.)

Alkuperäinen artikkelin lähde: WRAL TechWire