Immunoglobulins are producted as part of our body's adaptive immune system. This is the immunity that develops over one's lifetime as you become exposed to pathogens such as viruses, bacteria and fungi. Vaccinations are a way to cause your body to develop immunoglobulins that play a role in destroying the virus should you become infected. Our bodies contain large numbers of specialized immunoglobulins that prevent infection as well as regulate a number of other processes in the human body.
In order to utilize these immunoglobulins as therapy, they are first isolated from human plasma. Plasma is the straw-colored fluid that remains when red blood cells, white blood cells and platelets are removed from blood. Plasma is obtained from whole blood or plasma donations and manufacturers separate out and purify these proteins through a process called fractionation. In the case of immunoglobulins, these preparations are administered intramuscularly, subcutaneously or intravenously depending on your particular therapeutic needs.
Despite immunoglobulin therapy being available since the early 1950's there exists a lack of standards regarding how they should be administered and how therapy should be monitored and adjusted. Collectively, immunoglobulin products are FDA-Approved for treatment of primary humoral immunodeficiencies (PID), idiopathic thrombocytopenic purpurea (ITP), chronic inflammatory demyelinating polyneuropathy (CIDP), multi-focal motor neuropathy chronic lymphocytic leukemia (CLL) and Kawasaki Disease (KD). Additionally, immunoglobulin therapy has been shown to be effective in numerous off-label (non-FDA approved) indications.
As stated above, Immunoglobulin therapy is provided to patients for a wide range of medical conditions. It is administered intramusculary as prophylaxis to prevent certain viral infections in individuals traveling to areas of risk. For most conditions, it is administered subcutaneously or intravenously to patients. As mentioned previously, the immune system has been shown to play a much larger role in the body than simply preventing infections. When the body's immune system malfunctions, it can attack parts of the human body such as the skin, muscles or nerves. These are categorized as auto-immune disorders. Immunoglobulin therapy has been shown to be effective in many of these auto-immune disorders by blocking this process and/or bringing the malfunctioning immune system back into balance. Primary immune deficiencies can cause destruction of a number of organs and it is important to initiate immunoglobulin therapy (if appropriate) as soon as possible. The effect of the immune system in regulating other processes in the body may explain why immunoglobulin therapy is effective in so many other diseases beyond primary immunodeficiencies.