FDA approves Gamunex, Immune Globulin Intravenous , 10% Caprylate/Chromatography Purified

Journal of Drugs in Dermatology, Dec, 2003

HealthCare LLC, Biological Products Division (Bayer BP), has received approval from the FDA for Gamunex[TM], Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, a new and advanced immunoglobulin intravenous (IGIV) product. IGIV contains antibodies purified from the donated blood plasma of thousands of people. Because the protein structure of these antibodies is so fragile, the specifics of the manufacturing process, such as Bayer BP's Caprylate/Chromatography purification, have a direct impact on the quality of an IGIV product.

Bayer BP built a state-of-the-art manufacturing facility to house the new Gamunex purification process, the only facility of its size exclusively dedicated to producing IGIV.

Currently available IGIV products are based on retrofitted methods first introduced in the 1940s and '50s, which no longer provide a viable platform for significant product improvements. Bayer BP's product development includes breakthrough purification steps using Caprylate/ Chromatography that improves product purity and supply reliability.

This new approach also helps preserve the biological activity of the product by replacing the solvent-detergent method used in previous generations of IGIV products. In addition, Caprylate is a naturally occurring fatty acid that effectively, safely, and rapidly inactivates enveloped viruses, such as human immunodeficiency virus (HIV-I), West Nile virus, hepatitis B virus (HBV), and hepatitis C virus (HCV).

IGIV is used in the treatment of a variety of dermatologic and systemic conditions in which the host's immune system has been compromised in some way. IGIV has been shown to be effective in dermatologic conditions such as pemphigus, toxic epidermal necrolysis, and idiopathic thrombocytopenic purpura. Bayer BP already has commenced clinical trials to study treatment of neurological disorders, including multiple sclerosis and chronic inflammatory, demyelinating polyneuropathy (CIDP).

The most common side effects noted during clinical trials included headache, vomiting, fever, nausea, rash, and back pain.