#USA #GC Biopharma #Teaneck #IVIG #ALYGLO

GC Biopharma USA's Innovative Approach to IVIG Safety

GC Biopharma USA Inc., a prominent player in the field of plasma-derived products, recently showcased their latest advancements in intravenous immune globulin (IVIG) manufacturing techniques at the 2025 Clinical Immunology Society (CIS) Annual Meeting. The session, led by Dr. Ryan Dorfman, Chief Operating Officer of Prolytix, brought attention to a critical aspect of IVIG safety — the presence of residual activated coagulation Factor XI (FXIa).

Understanding FXIa's Role in Patient Safety

Dr. Dorfman emphasized during his presentation that even minimal amounts of FXIa in IVIG therapies can significantly increase the risk of thromboembolic events, which can be life-threatening for patients. He highlighted that the traditional manufacturing processes often rely on ethanol-based fractionation methods that can lead to the denaturation of proteins. This not only creates antigenic byproducts but can also activate the complement and coagulation cascades, further compromising patient safety.

In contrast, GC Biopharma's innovative approach utilizes cation exchange (CEX) chromatography, resulting in undetectable levels of FXIa. Dr. Dorfman described this method as a pivotal advancement that addresses safety concerns while preserving the therapeutic efficacy of IVIG treatments.

Symposium Insights

The symposium titled "The Impact of Process-Related Contaminants in IVIG on Adverse Patient Events and Tolerability: Exploring the Risks and Mechanisms" was an essential part of the discussions at the CIS meeting. This session not only outlines the safety benefits of GC Biopharma's processes but also reinforces the company's leadership in promoting dialogue about IVIG purity within the industry.

Dr. Dorfman, who serves as a paid consultant to the company, is recognized for his deep expertise in blood coagulation and protein biochemistry. His insights into the mechanical underpinnings of how contaminants affect IVIG tolerance and adverse events have garnered significant attention in the medical community.

Commitment to Safety and Quality

GC Biopharma's commitment to safety is not just a matter of compliance; it represents a proactive approach to elevating manufacturing standards in the industry. The advancements showcased at the annual meeting indicate their ongoing dedication to refining the safety profile of IVIG therapies.

The company's flagship product, ALYGLO®, is a 10% immunoglobulin G solution that enjoys FDA approval for treating primary humoral immunodeficiency (PI) in adults. It is a product born from a legacy of excellence in plasma product manufacturing and is distributed across more than 50 countries worldwide.

Conclusion

With their cutting-edge methodologies, GC Biopharma is setting new benchmarks for the industry, emphasizing that patient safety remains paramount. By addressing the underlying complexities associated with IVIG manufacturing, they not only enhance the efficacy of their products but also lay the groundwork for safer therapeutic options for patients who rely on these vital treatments.

For further details on ALYGLO and their innovative G-XI™ Technology, GC Biopharma invites stakeholders and patients alike to explore their offerings at www.alyglo.com and www.gcbiopharma.us.

As the field of biopharmaceuticals evolves, GC Biopharma USA continues to demonstrate that commitment to quality and safety can lead to transformative improvements in patient care.