Baxter facilities in Halle and Bielefeld, located in Germany's Westfalen region, have been recognized and certified for their capabilities in handling potent pharmaceutical compounds by SafeBridge Consultants, Inc., a leading occupational health and safety consulting firm. Baxter is the only company worldwide with facilities certified by SafeBridge doing both parenteral drug substance synthesis and parenteral drug product manufacturing and testing.
The facilities in Halle and Bielefeld support Baxter's BioPharma Solutions business, a contract manufacturing organization that partners with pharmaceutical companies to support their commercialization objectives. BioPharma Solutions provides scientific expertise, sterile manufacturing solutions, parenteral delivery systems and customized support services needed for parenteral products.
"Baxter is honored to be recognized by SafeBridge for our safe handling of potent pharmaceutical compounds and our abilities to handle and manufacture these materials to industry standards," said Dr. Burkhard Wichert, vice president of Manufacturing Oncology for Baxter's Halle facility. "We take our commitment to our pharmaceutical partners seriously and, ultimately, the patients who rely on the critical medications manufactured at our facilities in Halle and Bielefeld."
SafeBridge Certification provides an objective and scientific assessment of a company's ability to safely handle and manufacture to industry standards potent compounds such as oncology drugs, steroid and peptide hormones, and new generations of opioids. It also demonstrates that Baxter manufactures these compounds not only according to U.S. Food and Drug Administration, European and German laws, but to international industry occupational health standards as well. In addition to the recent SafeBridge Certification, the Halle facility is also OHSAS 18001 and ISO14001 certified.
The in-depth process employed by SafeBridge assessed Baxter's drug product manufacturing areas and quality control labs. SafeBridge noted Baxter's commitment to operating safely; strong collaboration between management, supervision and employees; procedures in place to support potent compound handling operations; a strong preventive maintenance program and effective health surveillance system.
"Baxter Oncology has established its operations in Halle and Bielefeld with safety and occupational health as cornerstones of its business in recognition of their product mix in the hazardous drug area," said John Farris, president and CEO of SafeBridge Consultants, Inc. "They have been known to us for several years as leaders in the area of containment of oncology drug product manufacturing and the certification of their facilities demonstrates this fact."
The manufacturing site in Halle focuses on the manufacture of oncology products and is one of the most advanced facilities for this type of contract manufacturing in the world. The facility's capabilities include lyophilization; process development; aseptic filling of oncology products, highly potent liquid and sterile powder vials in clinical and commercial batch sizes; antibody-drug conjugates; liposomes; and sterile crystallization of potent active pharmaceutical ingredients. For more information, please visit www.baxterbiopharmasolutions.com.