Bayer Biological Products (BP) has received approval from the Food and Drug Administration (FDA) for its new sterile filling facility (SFF) at the company's Clayton, North Carolina, manufacturing plant. The FDA approval marks a significant milestone for Bayer BP and the Clayton facility, where Bayer BP manufactures life-saving, plasma-based therapeutic proteins.
The SFF will be used for final container filling, freeze-drying, and pasteurization of all products manufactured in Clayton including 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 Koate-DVI Antihemophilic Factor (Human), used to treat hemophilia.
"This approval will allow Bayer BP to continue its leadership in product safety, and also to continue its long-standing commitment to patient communities in the therapeutic categories it serves," said Dr. Gunnar Riemann, president, Bayer BP Division.
The application to the FDA was submitted April 30, 2002. The recent approval allows Bayer to bring the new facility into operation immediately and will ensure Bayer BP's ability to maintain the very high standard of aseptic processing required to manufacture plasma-based products. The SFF will complement other existing process measures already in place and further assure that Bayer BP products maintain the highest possible safety profile.
Brand new, state-of-the-art mechanical equipment will be utilized in tasks such as filling bulk product and adding rubber stoppers to the product vials. By design, operators will be excluded from much of the process, allowing for state-of-the-art aseptic processing with a minimum of microbial deviations.
"The SFF approval allows us to complete the final stage of product manufacturing in the most up-to-date, state-of-the-art facilities," said Mary Kuhn, senior vice president of Bayer Biological Products and Clayton site manager. "The approval is a great accomplishment for Clayton and would not have been possible without the unwavering commitment of the employees who helped drive this project forward."