BioSpace: GigaGen’s Recombinant IVIG Technology Could Be Potential Solution to Global Shortage


A critical supply shortage of intravenous immunoglobulin (IVIG) in the United States has left some room for doubt about whether or not that critical care will make it to some patients.

IVIG contains antibodies that are harvested from plasma provided by thousands of donors across the country. IVIG, which is injected into patients, helps them fight off various infections. IVIG is also used to treat some disorders of the muscles and nervous system. A shortage, which the U.S. Food and Drug Administration confirmed in August, increases the risk to patients. In its announcement, the FDA said some hospitals, medical systems and other health care providers have taken steps to “optimize” limited supplies of IVIG products. Some of those optimization strategies include the lowering of doses, delay of treatments, alternative therapies where applicable and prioritization based on medical need.

In a report on the state of the IVIG supply, The Wall Street Journal noted that IVIG suppliers like Octopharma, which develops products for Pfizer, and Takeda are boosting production of their products in order to meet demand. However, those companies noted that some delays in manufacturing and shipping are likely to continue to impact the supply levels.

While the nation grapples with the shortage, California-based GigaGen may have a solution to prevent future shortages – but it’s a solution that is still a few years off. GigaGen is developing a new approach to current IVIG therapies that is not subject to supply shortages and overcomes other significant challenges of plasma-based products. The company uses a proprietary platform to create recombinant polyclonal immunoglobulin (IgG) therapies that don’t rely on human plasma supplies.

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