GC Biopharma said on the 9th that the Laredo, Texas, plasma center of its U.S. subsidiary ABO Plasma obtained authorization from the U.S. Food and Drug Administration (FDA).
In the United States, only plasma collected at FDA-approved plasma centers can be used for commercial sale or as a pharmaceutical raw material. With this authorization, ABO Plasma has secured FDA approval for all seven plasma centers it operates in the United States, strengthening its capacity to secure raw plasma.
ABO Plasma plans to open its eighth center in Eagle Pass, Texas, within the year. The company plans to raise the operating rate of all centers to 100% by 2028 and procure 80% of the raw plasma needed to produce "Alyglo" in-house.
The company said this is "a strategy to proactively manage supply chain risks while strengthening the internalization of the value chain," adding that it "can reduce dependence on external markets, secure cost competitiveness, and maximize operating margin."
Alyglo is an intravenous immunoglobulin therapy purified from immunoproteins in plasma (the remaining liquid after removing cells from blood), used to treat various immune disorders such as primary immunodeficiency. It received FDA authorization in Dec. 2023 and was launched in the United States in the second half of 2024.
Heo Eun-cheol, CEO of GC Biopharma, said, "We will strengthen the competitiveness of our U.S. plasma fractionation business based on a solid business structure." Meanwhile, GC Biopharma is developing a subcutaneous (SC) immunoglobulin that improves the dosing convenience of the intravenous (IV) Alyglo.