CLAYTON – Grifols, a global biotherapeutics company with major operations in North Carolina, has received approval from the U.S. Food and Drug Administration for a new formulation of GamaSTAN, its medicine for treating patients who’ve been exposed to the hepatitis A and measles viruses.

GamaSTAN is the only immune globulin product on the U.S. market approved for post- exposure protection against the two viruses. It is now available to healthcare providers across the country, the company said in a news release.

“This advancement in the GamaSTAN formulation marks an important milestone in Grifols’ ongoing R&D efforts, and we are confident that it will continue to be an important treatment option for healthcare providers,” said Bill Zabel, president of the company’s North America sales and commercial operations.

The product’s approval and roll-out come amid a national resurgence of hepatitis A, a contagious liver infection, and measles, a contagious infection in young children that had been nearly eradicated through vaccinations.

“Immune globulins such as GamaSTAN have been a valuable treatment option for many decades because they offer immediate and rapid protection with antibodies that fight infection,” said Stephen Scholand, M.D., an infectious disease specialist at MidState Medical Center in Meriden, Conn.

When administered within two weeks after exposure to the hepatitis A virus, immune globulin is 80 to 90 percent effective in preventing infection, according to the U.S. Centers for Disease Control.

In contrast, vaccinations – while still a valuable option – may not take effect for several weeks because the immune system needs time to produce antibodies against the viruses, Scholand said.

The CDC recommends immune globulin treatment after exposure to the hepatitis A virus in people who are immunocompromised, under 1 year old or over 40 years old, or who have cancer, chronic liver disease or kidney disease.

GamaSTAN is produced at Grifols’ growing manufacturing campus in Clayton.

Investing $210 million to expand existing $400 million Clayton campus

The company is investing $210 million in two new facilities there to help meet the growing demand for medicines such as GamaSTAN that are derived from human blood plasma.

Grifols broke ground in March for a $120 million purification and filling facility that will mainly produce immune globulin and factor VIII products. Immune globulin, a class of proteins in serum and immune system cells that function as antibodies, is used to treat various autoimmune, infectious and other diseases. Factor VIII, a blood protein involved in clotting, is used to treat the bleeding disorder hemophilia A.

The three-story, 150,000-square-foot facility, scheduled to begin operating in 2022, will also support the Clayton site’s $400 million plasma-fractionation plant that opened in 2014.

Construction of a new, $90 million fractionation facility is also under way. Scheduled to open in 2021, the facility will add 6 million liters of capacity per year.

Plasma, the water portion of blood, is rich in proteins, some of which have therapeutic value. Fractionation separates proteins so they can be purified and sterilized for use in medicines that restore or replace missing proteins.

Treating a wide range of serious diseases

Grifols’ medicines are used to treat a wide range of diseases including hemophilia, emphysema, acute liver failure, hepatitis A and immunodeficiency disorders.

Grifols’ two new facilities are the latest of several expansions that are making the Clayton site one of the world’s largest manufacturing plants for plasma-derived medicines.

In December 2017, Grifols tripled the size of its footprint there by purchasing 467 acres of land for future expansion. In July 2017, the company opened a 112,000-square-foot office building for more than 400 employees.

Investments in the site between 2017 and 2022 will total about $320 million, the company said. That’s in addition to about $760 million in capital expansions between 2011 and 2017.

Grifols established its presence in North Carolina in June 2011 when it acquired Talecris Biotherapeutics Holdings Corp. for $3.4 billion.

Close to 2,500 people work for Grifols throughout North Carolina. This includes about 1,650 people at the Clayton campus, 500 at corporate offices in Research Triangle Park, and 200 others, mostly at plasma-collection centers across the state.

Grifols expects to hire about 250 new employees in Clayton over the next dozen years. The company already is the largest employer in Johnston County.

Grifols has partnered with Johnston Community College on workforce training and participated in an April groundbreaking ceremony for a new Workforce Development Center at the college. The Center is a 30,000-square-foot educational and technical skills training facility with a focus on life sciences programming, business training and workforce development in biotechnology and other sciences.

Grifols, headquartered in Barcelona, Spain, has about 18,300 employees in 30 countries.

In 2017, its global sales exceeded 4.3 billion euros.

(C) N.C. Biotechnology Center