Grifols gets FDA approval for expanded immunoglobulin purification and filling capacity in Clayton

Grifols, a global leader in plasma medicines, today announced it has received approval from the U.S. Food and Drug Administration (FDA) for its new immunoglobulin (Ig) purification and filling facility at its Clayton manufacturing campus, one of the world’s largest sites for producing plasma-derived medicines.

The FDA approval is for Gamunex®-C, a leading Grifols Ig brand. This enables the company to manufacture an additional 16 million grams of the therapy annually, bringing total global capacity to 60 million grams. Soon Grifols will seek FDA authorization for the new plant to also produce XEMBIFY®, its quickly growing subcutaneous Ig.

Patient need for Ig therapeutics is expected to rise, especially to treat the growing prevalence of immunodeficiencies, which account for approximately 40% to 55% of the total Ig market, according to the company.

Purification and filling follows the fractionation of plasma into separate proteins, including Ig, alpha-1 proteinase inhibitor, albumin and antithrombin-III, each indicated for different conditions. It is the last step before finished medicine vials are packaged and shipped.

Grifols Engineering engineered and built the new 150,000-square-foot, Green Globes®-certified purification and filling facility. 

It is the most recent expansion of Grifols’ flagship Clayton plasma-medicine manufacturing campus. 

As it approaches its 50-year anniversary in 2024, the site has evolved into a global showcase for the advanced manufacturing of hemoderivatives. 

Over the last decade, Grifols has invested approximately USD 1 billion in the site, including a new plasma fractionation building that began production in early 2022 and increases the site’s overall fractionation capacity to 12 million liters/year, more than half of the company’s global total.

“Having achieved FDA approval earlier than expected for our new purification and filling plant, Grifols continues investing in new technology and expanding our plasma-medicine manufacturing capabilities to address the growing need for immunoglobulins and other plasma-protein therapeutics,” said Victor Grifols Deu, Grifols Chief Operating Officer.