Bayer develops novel immune globulin manufacturing process
Bayer Biological Products (BP), of the US, has introduced an innovative viral inactivation technology in the production of intravenous immunoglobulin, a plasma-based therapy used to treat people with compromised immune systems.
Bayer Biological Products (BP), of the US, has introduced an innovative viral inactivation technology in the production of intravenous immunoglobulin, 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 intravenous immunoglobulin.
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 IGIV, may be reduced in the final plasma-derived product.
Caprylate is highly effective against human viruses, as well as surrogate testing viruses, such as bovine viral diarrhoea virus (a model for hepatitis C virus), even at low doses. 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.
A naturally occurring fatty acid widely found in animal and vegetable fats, caprylate has been used for more than 50 years at high doses as a stabilizer of albumin, and as an energy source during total parenteral nutrition (TPN). It therefore has an unprecedented safety and tolerability record.