Grifols Receives FDA Approval for New Immunoglobulin Facility

Why It Matters:

The FDA approval enables Grifols to manufacture an additional 16 million grams of Ig therapy annually, meeting the growing demand for immunoglobulin therapeutics to treat immunodeficiencies. This expansion highlights the company's commitment to addressing patient needs and advancing plasma medicine manufacturing capabilities.

The Details:

• The FDA approval is for Grifols' leading Ig brand, Gamunex®-C.

• The new facility will increase global capacity to 60 million grams of therapy per year.

• Grifols plans to seek FDA authorization for the facility to produce XEMBIFY®, its subcutaneous Ig therapy.

• Immunodeficiencies account for 40% to 55% of the total Ig market, driving the need for increased production.

• The purification and filling facility is the final step in the manufacturing process before medicines are packaged and shipped.

• The facility was engineered and built by Grifols Engineering and is Green Globes®-certified.

• Grifols' Clayton campus has become a global showcase for advanced manufacturing of hemoderivatives.

• The site has received approximately $1 billion in investments over the last decade, including a new plasma fractionation building.

Conclusion:

Grifols' FDA-approved purification and filling facility at its Clayton manufacturing campus will significantly increase the production of immunoglobulin therapies, addressing the growing demand for these treatments. The company's ongoing investments in advanced manufacturing capabilities highlight its commitment to improving patient care.