Why a JoCo facility could soon be mass producing a COVID-19 treatment

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While the world battles the COVID-19 pandemic, a drugmaker with a massive presence in North Carolina is looking for recovered COVID-19 patients to donate plasma toward the cause – and if successful, will mass-produce a treatment in Johnston County.

Grifols (Nasdaq:GRFS), a Spanish pharmaceutical company that calls Johnston County home to its largest manufacturing site, has begun the process of identifying, screening and selecting recovered COVID-19 patients to donate plasma. The collected plasma will be used to produce a therapeutic – specifically a hyperimmune globulin – that Grifols hopes will be an effective treatment for the disease.

The process works from the concentration of antibodies in plasma that the body develops in the course of fighting a new disease. The hope is that crafting a therapeutic out of recovered patients’ plasma will result in a ready-made treatment for future patients.

The initial donations will be used to conduct controlled clinical trials with the National Institutes of Health (NIH) to evaluate its safety and efficacy as a viable treatment for COVID-19. Grifols is conducting the tests between itself, the U.S. Food and Drug Administration (FDA) and the U.S. Biomedical Advanced Research Authority.

If successful, Vlasta Hakes, the company’s director of corporate affairs, says it will be looking at scale up the therapeutic.

“At this time we’re still in the experimental stage,” she says. “The hope is that this is something that will be able to be mass produced, but at this point we’re just doing the initial batches.”

One reason that Hakes says the company believes it can be instrumental in the fight against the virus is its Johnston County manufacturing center – which she says would be tasked with producing the drug.

The company previously leaned on the facility during the last Ebola outbreak in Liberia – it also produced hyperimmune globulin as a therapeutic. In fact, the company specifically designed and constructed a building at its North Carolina facility for the processing of immune globulins to treat emerging infectious diseases.

The company employs around 2,500 in the Triangle.

“We know that we’re uniquely positioned to be able to get those donations from those individuals who have recovered from COVID-19,” Hakes says, noting the company has 250 collection centers. “Secondly, we have that manufacturing facility in Clayton, that’s ready to go. That means as soon as we have that plasma, we can start putting it into the manufacturing process to make medicine that can then go much quicker to clinical trials than I think some of the other companies could.”

Currently, the company is focused on collecting plasma in cities that had outbreaks early in the pandemic, including Chicago, Dallas, Houston, Los Angeles, San Antonio, San Diego and Seattle. It says it will likely announce additional locations in the near future.

Interested individuals will be screened by the company and directed to a local Grifols plasma donor center. Patients that meet the criteria include those who have had a positive diagnosis and have completely recovered from symptoms for at least 28 days prior to donation or 14 days prior alongside a negative molecular test.

The amount of therapeutics that can be produced is directly correlated to the overall supply of plasma coming in. Hakes says if the initial batches show success and the company moves to mass production, it is still working to estimate exactly how much plasma would be needed.

“We know we’re going to need a lot,” Hakes says.

Original Article Source: Triangle Business Journal