The World’s First Recombinant IgG
Immune deficiencies are characterized by the body’s inability to properly make antibodies. Since antibodies are required to fight infection, patients with immune deficiencies are susceptible to recurrent and severe infections caused by viruses and bacteria that healthy people naturally fight off.
Most patients with immune deficiency are treated with plasma-based drug products derived from plasma samples that are pooled from thousands of human donors. Such products include intravenous immunoglobulin (IVIG) and hyperimmunes, a variation of IVIG prepared from the plasma of donors with high titers of antibodies to a specific pathogen. Hyperimmunes are used to treat acute infections or prevent infection in immune compromised patients, such as after organ transplantation.
GigaGen’s recombinant polyclonal IgG solves the significant challenges of these current plasma-based products. GigaGen’s products decrease risk for contamination, are not subject to supply shortages and remain consistent from batch-to-batch. In addition, they’re engineered to have higher potency than plasma-derived equivalents. GigaGen captured millions-diverse DNA libraries from B cell and plasma cell repertoires from human donors and used these libraries to manufacture recombinant IgG proteins. We validated the purified, massively polyclonal protein product with in vitro and mouse models.
GigaGen’s recombinant IgG products are being co-developed with pharmaceutical partner Grifols.