Anchoring the U.S. Supply Chain: GC Green Cross Expands 30-Year Cytiva Partnership to Secure Alyglo Production

GC Green Cross has secured priority access to critical manufacturing consumables to stabilize the production of Alyglo, its flagship blood product, as commercial distribution scales up in the United States. The company is also deepening its 30-year relationship with Cytiva—a global provider of biopharmaceutical manufacturing equipment and materials—to expand their collaboration into manufacturing processes for next-generation therapeutics.

On July 16, GC Green Cross announced it signed a memorandum of understanding (MOU) the previous day at Cytiva’s Asia-Pacific Fast Trak Center in Songdo, Incheon. The strategic agreement focuses on securing a resilient supply of key consumables used in biopharmaceutical manufacturing and expanding joint process technology development.

The two companies first established their business relationship in 1996, marking three decades of cooperation this year. Key executives, including Shin Woong, Head of Operations at GC Green Cross, and Kim Sung-pil, CEO of Cytiva Korea, attended the signing ceremony.

An Essential Biomanufacturing Alliance

While Cytiva is not a household name among everyday consumers, it is an indispensable pillar on biopharmaceutical manufacturing floors worldwide. Operating as part of the U.S.-based Danaher Group, Cytiva supplies cell culture equipment, media, drug substance separation and purification systems, virus-removal filters, and single-use consumables. Essentially, while GC Green Cross develops and manufactures the therapies, Cytiva provides the foundational equipment, materials, and process engineering required to bring them to life.

Filters and purification consumables used in biologics manufacturing are highly critical to maintaining product purity, safety, and batch-to-batch consistency. Because any modification to manufacturing materials or setups requires manufacturers to rigorously re-verify the impact on drug quality and safety, the long-standing trust between the two companies has been a major operational asset. Over the decades, the partnership has strengthened as Cytiva supplied tailored consumables optimized for GC Green Cross's long-running production lines alongside continuous technical support.

Securing Key Filters for Alyglo

The centerpiece of the new agreement is a priority supply framework for virus-removal filters and other critical consumables required to manufacture Alyglo. The proactive arrangement aims to eliminate production risks by ensuring uninterrupted access to critical materials, even during volatile global supply chain disruptions.

Alyglo is an intravenous immunoglobulin G (IVIG) liquid therapy derived from human plasma. It is indicated for antibody replacement in adult patients with primary humoral immunodeficiency (PI) who lack a fully functioning immune system. The therapy received official approval from the U.S. Food and Drug Administration (FDA) in December 2023.

Given that human plasma serves as the raw material, eliminating viral risk during manufacturing is paramount. Alyglo’s production line incorporates a robust, three-step viral clearance strategy: plasma fractionation, solvent/detergent treatment, and nanofiltration. The virus-removal filters covered under the priority supply agreement are crucial to this nanofiltration stage; any delay in securing them directly impacts commercial production schedules.

Expanding into Next-Generation Therapeutics

Looking to the future, the two companies are expanding their plasma-focused alliance into manufacturing processes for messenger RNA (mRNA) therapies as well as advanced cell and gene therapies.

GC Green Cross will leverage Cytiva’s Songdo Fast Trak Center to obtain specialized technical support aimed at refining next-generation manufacturing lines, while also expanding training programs for its research and production workforce. The Fast Trak Center specializes in bioprocess development, technology transfer, and hands-on training, helping companies scale up laboratory-stage innovations into robust commercial manufacturing processes.

"The trust we have cultivated with Cytiva over the past 30 years has been a vital foundation for GC Green Cross’s growth into a leader in the global blood products market," said Shin Woong. "This agreement serves as a launchpad for strategic cooperation, aimed not only at guaranteeing a stable global supply of Alyglo but also at sharpening our competitive edge in next-generation biopharmaceuticals."