GC Biopharma announced on Thursday that its U.S. subsidiary, ABO Plasma, has received the U.S. Food and Drug Administration (FDA) approval for its plasma center in Laredo, Texas.
This milestone was achieved more than three months ahead of schedule, showcasing ABO Plasma’s operational expertise and the Laredo center’s ability to swiftly stabilize its processes.
In the United States, only plasma collected at FDA-approved centers can be sold commercially or used as pharmaceutical raw materials. With this latest approval, ABO Plasma has now secured FDA authorization for all seven of its operational plasma centers in the U.S., significantly boosting its capacity to source raw plasma.
ABO Plasma plans to open its eighth center in Eagle Pass, Texas, by the end of the year. The company aims to reach 100% operational efficiency across all centers by 2028, enabling it to source 80% of the raw plasma needed for Alyglo production in-house. This strategy aligns with global plasma fractionation companies’ efforts to proactively manage supply chain risks while strengthening their value chain integration.
The internalization of raw materials is expected to be a key driver in improving future profit structures. By reducing dependence on external markets, the company can enhance its cost competitiveness and maximize the operating profit margins of its products.
Chief Executive Officer (CEO) Heo Eun-cheol stated that it will continue to strengthen the competitiveness in the U.S. plasma fractionation market, building on our robust business structure.
Meanwhile, GC Biopharma is developing a subcutaneous (SC) immunoglobulin formulation to enhance the convenience of administering Alyglo, which is currently available only as an intravenous (IV) injection.