RESEARCH TRIANGLE PARK, N.C. -- Bayer Biological Products (BP) announces that based on findings from studies it has recently conducted on a closely related virus, it has concluded that its licensed manufacturing technologies successfully inactivate the monkeypox virus. Bayer BP manufactures plasma-derived therapies for the treatment of disorders such as alpha-1 antitrypsin deficiency, primary immune deficiencies, and hemophilia. Viral contamination is a concern among patients who use these therapies because the products are derived from donated human plasma.
"I am very proud of what we are accomplishing and how we are leading the industry in the area of product safety," said Dr. Gunnar Riemann, president of Bayer Biological Products Division. "Whether it is through the introduction of new products or technology, like our second generation IGIV product, by setting an industry precedent through the introduction of tamper-resistant packaging, or through our vigilance in proactively evaluating the inactivation and removal of emerging pathogens like monkeypox, Bayer's holistic approach to product safety is unwavering."
"Although there are many other steps and layers of safety we deploy to help ensure the raw plasma and finished products are the safest possible, Bayer BP employs robust viral inactivation/removal steps to further safeguard against contamination from emerging viruses, such as monkeypox," according to Bayer scientist Dr. Steve Petteway.
Monkeypox is a member of the orthopoxvirus family, which is closely related to smallpox and the virus used in the smallpox vaccine, vaccinia. The monkeypox virus has a lipid membrane, or "envelope," that encases the virus capsid. The manufacturing process for all Bayer BP products include at least two steps that very effectively inactivate enveloped viruses. These steps include:
-- Solvent/detergent treatment
-- Pasteurization, or heat treatment
-- Extraction using acetone
-- Incubation in acidic solutions
-- A new viral inactivation technology utilizing caprylate
Bayer BP's testing has specifically confirmed the inactivation of the Vaccinia virus, a virus very closely related to monkeypox, from the manufacturing processes for Prolastin, Alpha1-Proteinase Inhibitor (Human), used in the treatment of genetic emphysema; Gamimune N, Immune Globulin Intravenous (Human), produced for patients with immune deficiencies; IGIV-C a new generation immunoglobulin product; and from protein media used in the fermentation process for Kogenate FS, Antihemophilic Factor (Recombinant) Formulated with Sucrose, used by patients with hemophilia A.
Source: Bayer Biological Products