SOCIAL CIRCLE, Ga. — The first patient has been enrolled in a clinical trial to study if a medicine produced here can become one of the earliest treatments for adults hospitalized with COVID-19.
Takeda Pharmaceutical Co. Ltd.’s Georgia Plasma Manufacturing Facility near Social Circle is one of two sites in the world that has manufactured small amounts of hyperimmune globulin for clinical trials as part of its role in the 12-member CoVIg-19 Plasma Alliance.
Takeda produced test samples of the medicine using plasma containing antibodies from recovered COVID-19 patients, officials said.
Carlos Soto, vice president of manufacturing for Takeda, said company officials were “proud” the Plasma Alliance chose the facility — which straddles the line between Newton and Walton counties — to produce the samples.
Soto heads Takeda’s manufacturing facility off I-20 in the Stanton Springs Business Park which is partly in Newton, Walton and Morgan counties.
Takeda and U.S.-based CSL Behring founded the Alliance in April to work to create an unbranded medicine derived from plasma to treat the most at-risk COVID-19 patients, according to information from the alliance.
The Alliance also includes plasma companies Biotest, BPL, LFB, and Octapharma, along with additional industry members ADMA Biologics, BioPharma Plasma, GC Pharma, Liminal BioSciences, National Bioproducts Institute and Sanquin.
Takeda’s Social Circle facility and CSL’s Switzerland facility were two sites chosen to manufacture the medicine for the clinical trials that began Oct. 9, the website FiercePharma reported.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is sponsoring the trial.
It will evaluate if it is safe, tolerable and effective as a medicine for treating hospitalized adults at risk for serious complications of COVID-19 disease, officials said.
Japan-based Takeda acquired the facility in Stanton Springs as part of its purchase of original owner Shire in early 2019.
Soto said Takeda will continue to produce the hyperimmune globulin medicine so it will be prepared to produce it in large quantities in “weeks or months” if federal officials give their approval.
“We can scale up quickly,” he said. “It’s more difficult to scale down than to scale up.”
The Alliance is asking recovered COVID-19 patients to donate plasma so it has enough quantity to produce the medicine if approved, Soto said.
The donation sites closest to Newton County are BioLife Plasma Services in McDonough on Plaza Parkway, and on Centerville Highway in Snellville. Both are accepting donations from recovered COVID-19 patients, according to the website thefightisinus.org.
Soto said the process the Alliance is using can produce a medicine that differs from the convalescent plasma used in transfusions to individual COVID-19 patients, officials said.
Typically, vaccines try to simulate a disease and prompt the recipient’s body to create antibodies to fight it off. This medicine places the antibodies into the patient to fight off the disease.
The process is essentially the same one plasma sites like Takeda in Stanton Springs have used for decades to manufacture antibody therapies to treat people with immune system deficiencies, company spokesman Gabe Khouli said.