GC Biopharma announced on the 14th that all six of its plasma centers in the United States have received approval from the U.S. Food and Drug Administration (FDA), establishing a stable supply base for source plasma.
The company stated that its plasma center located in Calexico, California, recently obtained FDA approval. With this, all six U.S. plasma centers operated by ABO Holdings—a company acquired by GC Biopharma in January to support the mid-to-long-term growth of its immune globulin product ALYGLO—have now completed the FDA licensing process. This sets the stage for GC Biopharma to collect plasma in the U.S., import it into Korea for manufacturing, and then export the finished ALYGLO product back to the U.S. market.
In the United States, FDA approval is mandatory for plasma centers to collect and sell plasma. Only after passing rigorous safety and quality inspections can these centers be authorized to distribute plasma.
With the latest approval, GC Biopharma plans to ramp up operations across its six centers located in California, Utah, and New Jersey. Starting in the second quarter, the company will accelerate donor recruitment with the aim of driving top-line growth in the second half of the year. It also plans to open two additional plasma centers in Texas by 2027, expanding its total to eight.
Stable plasma supply is a critical factor in the plasma-derived biopharmaceutical business. For this reason, global leaders in the field—such as CSL Behring (Australia), Takeda (Japan), and Grifols (Spain)—also operate their own plasma centers in the United States.
Eun-chul Huh, President and CEO of GC Biopharma, commented, “We will secure stable sales of ALYGLO through our U.S. based plasma centers. This is expected to significantly contribute to improving the company’s profitability.”
