Bayer Biological Products (BP) announced that its manufacturing technologies successfully inactivate vaccinia, the live virus utilized in the National Smallpox Vaccination Program. These results are the first in the industry to definitively address patient concerns that, despite implementation of FDA-recommended donor deferral criteria to eliminate the potential risk of such transmission, plasma donors recently vaccinated for smallpox could inadvertently contaminate therapeutic protein products manufactured from their plasma.
Specifically, the testing confirmed the complete inactivation of vaccinia from the manufacturing processes for Prolastin, Alpha1-Proteinase Inhibitor (Human), used in the treatment of genetic emphysema; Gamimune N, Immune Globulin Intravenous (Human), indicated for patients with immune deficiencies; and hyperimmune products BayRab, BayTet, BayGam, BayRho-D, and BayHep B. Bayer BP scientists also confirmed complete inactivation of vaccinia from protein media used in the fermentation process for Kogenate FS, Antihemophilic Factor (Recombinant) Formulated with Sucrose, used by patients with hemophilia A. Additionally, tests of the new viral inactivation process used in the manufacture of Gamunex, the next generation immune globulin, which is undergoing final review at FDA, demonstrate that use of caprylate completely inactivated the vaccinia virus within minutes.
"Our pathogen safety group continues to lead the biological products industry in research and application of technologies that help ensure the safety of biological products," said Michael Fournel, senior vice president for Research and Development at Bayer BP. "With these tests confirming our preliminary research findings, we now can assure patients who rely on our products that they are safe from potential contamination with vaccinia."
Dr. Gunnar Riemann, president, Bayer Biological Products Division, put the vaccinia test results in the context of Bayer's larger, more holistic approach to patient safety. "From the raw materials used in manufacturing our products, to our leadership in bringing tamper-resistant packaging to the biological products industry, our goal is to establish a new paradigm for safety in biological products."
Viral inactivation processes used in the manufacture of Bayer BP's life-saving and life-enhancing processes include pasteurization (heat treatment), solvent/detergent treatment, extraction using acetone, incubation in acidic solutions, and the new caprylate technology to be used in the manufacture of Gamunex, once that product receives final approval. While these processes are known to be effective against the class of enveloped viruses that include vaccinia, Bayer BP is the first manufacturer to confirm specific inactivation through experiments using its own products and vaccinia virus. This testing on vaccinia, much like the previous work confirming inactivation of West Nile virus, adds to the body of knowledge being generated by the Bayer BP pathogen safety group confirming the excellent safety profile of Bayer's biological products.