Recombinant Polyclonal Therapies

Recombinant Polyclonal Therapies

GigaGen has conducted successful preclinical validation of the world's first recombinant IgG therapies to treat patients with immune deficiencies.

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 are able to fight off naturally.

Most patients with immune deficiency are currently treated with plasma-based drug products created by collecting and pooling plasma samples from thousands of human donors.  The IgG antibodies are isolated from the plasma pool and processed to remove impurities and protect against contamination. These drugs include intravenous immunoglobulin (IVIG), and hyberimmunes - variations 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 products have advantages over plasma-based products in that they decrease risk for contamination, supply shortage, and batch-to-batch inconsistency. Our products are also engineered to have higher potency than plasma derived equivalents.

In our preclinical validation work, we captured millions-diverse DNA libraries from B cell and plasma cell repertoires from human donors and used these libraries to manufacture the recombinant IgG proteins in Chinese hamster ovary (CHO) cells. 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.