Bayer BP develops novel manufacturing process

Bayer Biological Products (BP), of the US, has introduced an innovative viral inactivation technology in the production of intravenous immunoglobulin (IVIG), a plasma-based therapy used to treat people with compromised immune systems. Bayer BP has introduced caprylate as an effective and safe alternative to solvent-detergent (S/D) treatment for inactivating and removing enveloped viruses such as HIV-1 and hepatitis B virus in the manufacture of IVIG.

Although effective, S/D has some limitations in that it requires longer processing time, removal of the inactivating agent, and results in lower product yields. In addition, biological activity, critical to the effectiveness of immunoglobulinV, may be reduced in the final plasma-derived product. In contrast to S/D, inactivation activity of caprylate is virtually instantaneous. It also inactivates certain viruses 20-60 times faster than S/D, allowing for a higher yield and preservation of biological activity of the final IVIG product.