On Feb. 27, at GC Biopharma Ochang Plant within the Ochang Scientific Industrial Complex in Ochang-eup, Cheongju, North Chungcheong Province, South Korea, employees dressed in white, complete with dust caps and coveralls, were observed through a viewing window. In the plasma storage inspection room, they meticulously labeled containers filled with an orange liquid known as plasma.
Blood consists of tangible elements, such as red and white blood cells, and a liquid part known as plasma. Various separation and purification processes transform plasma proteins into several blood plasma products, including ‘albumin,’ ‘clotting factor preparation,’ and ‘immunoglobulin preparations.’ These products are crucial for treating patients with immunodeficiency and rare diseases, such as congenital immunodeficiency and immune thrombocytopenia.
Since establishing Korea’s first blood plasma facility in 1971, GC Biopharma has been at the forefront of advancing hematology technology. Recently, the company achieved a significant milestone when its immunoglobulin product, ‘Alyglo,’ passed all the necessary evaluations by the United States regulatory authorities, securing a U.S. item license. This achievement marked the first time a Korean blood plasma product overcame the regulatory barriers to enter the U.S. market.
Advanced technology and substantial investment in facilities are vital for producing and commercializing blood plasma. A strict regulatory process, including thorough documentation and due diligence, is also essential. Consequently, only a few producers of blood plasma exist globally, making it a key competitive advantage for companies in this field.
The approval of Alyglo by the U.S. Food and Drug Administration (FDA) culminates GC Biopharma’s 13-year effort to enter the U.S. market. The company had previously applied for FDA approval but was required to provide additional data on its manufacturing process twice. It was only after a third attempt that success was achieved. Since July of this year, GC Biopharma has commenced the export of Alyglo to the U.S. market, with production taking place at the Ochang Plant.
Inaugurated in 2007 on a 130,000-square-meter site, the Ochang Plant is pivotal for producing GC Biopharma’s blood plasma and other critical products. It boasts Asia’s largest plasma processing capacity, handling 1.3 million liters annually. The plasma processed here is exported to 32 countries worldwide.
Park Hyung-joon, the plant manager of GC Biopharma’s Ochang Plant, explained, “The production capacity of a blood plasma plant is contingent on the volume of plasma it processes. Our capacity of 1.3 million liters annually is significantly higher than the 200,000 liters received by the Korean Red Cross each year by five to six times.”
In April of the previous year, the Ochang Plant underwent a manufacturing facility inspection by the U.S. FDA for the licensing of Alyglo, thereby achieving the status of a ‘CGMP production facility’ in compliance with U.S. Good Manufacturing Practice standards. These regulatory achievements paved the way for the FDA’s approval of Alyglo in December of the same year.
With this FDA approval as a foundation, the GC Biopharma Ochang Plant aims to become a CGMP-certified facility with sales of $750 million (1 trillion won) by 2030 through its blood plasma, gene recombinant products, and contract manufacturing organization (CMO) operations. Specifically, GC Biopharma intends to develop its CMO business as a key growth driver. The sales of Alyglo produced at the Ochang Plant will be managed by GC Biopharma USA under the leadership of Lee Woo-jin, the global business head of GC Biopharma, who brings 30 years of experience at GC Biopharma to his role as CEO of GC Biopharma USA.
Lee said, “Our goal is for Alyglo to achieve consolidated sales of $50 million (66.5 billion won) this year and to sustain an annual growth rate of over 50%, reaching approximately $300 million (399.4 billion won) in revenue by 2028, five years after launch.”
