Recombinant Gammaglobulin (rIVIG)

GigaGen has conducted successful preclinical validation of the world's first recombinant IgG therapy to treat primary immune deficiencies.

Primary immune deficiencies (PID) are a group of more than 200 disorders characterized by the body’s inability to properly make antibodies. Since antibodies are required to fight infection, patients with PID are susceptible to recurrent and severe infections caused by viruses and bacteria that healthy people are able to fight off naturally.

Patients with PID are currently treated with a plasma-based drug product 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. This drug is called Intravenous Immunoglobulin (IVIG) or Subcutaneous Immunoglobulin (SCIG), depending on the mode of delivery.

GigaGen’s recombinant IVIG has higher potency than plasma IVIG and decreases risk for contamination, supply shortage, and batch-to-batch inconsistency. 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 IV/SCIG protein in Chinese hamster ovary (CHO) cells. We validated the purified massively polyclonal protein product with in vitro and mouse models.

If you are interested in partnering on recombinant IVIG or massively polyclonal antibodies, please contact us for more information.