There are a number of elements that are necessary to remain a leading service provider in the area of contract manufacturing of cytotoxic parenterals.
Continuous investments, for example, can ensure that manufacturers keep pace with or exceed current industry technical developments and quality requirements. In 2013, Baxter’s BioPharma Solutions business announced a third expansion of their contract manufacturing facility in Halle, Germany (following previous expansions in 2007 and 2011) to meet clients' growing needs for cytotoxic manufacturing.
This expansion will become fully operational this year and is designed to support international manufacturing and regulatory requirements serving the needs of clients globally. Offering two highly flexible filling lines equipped with state-of-the-art technology and optimised for high yields and quality process performance, the expansion includes the installation of a new commercial filling line with two freeze dryers (40 square meters each), as well as a clinical filling line with an additional freeze dryer (17 square meters).
Both the new commercial and clinical lines will be equipped with an automated loading/unloading, capping and inspection infrastructure, allowing handling of products with an OEL below 0.01 µg/m³. Compounding will be possible in stainless steel vessels, glass vessels, or disposable bag systems – offering the best solution to meet particular product needs. 100% fill weight checks help to assure reliable results.
Clients will be as close to their product as possible: a glass design provides full transparency including the manufacturing activities in the sterile core.
With the addition of this latest expansion, BioPharma Solutions’ Halle facility becomes one of the largest CMOs for lyophilized cytotoxic parenterals.
It's essential to provide clients with the resources to help find the overall best solution for their cytotoxic parenteral needs, and this most recent expansion further enhances Baxter’s complete range of cytotoxic manufacturing resources to support early clinical phase drug supply through commercial scale-up, product launch and lifecycle management for global markets.
Clients rely on Baxter BioPharma Solutions' wide range of experience with more than 110 completed product transfers including commercial-scale production of cytotoxic emulsions, liposomes, antibody-drug conjugates (ADCs), and traditional small molecules. "Cancer incidence is on the rise and cytotoxic therapies continue to be at the center of oncology treatment programs," said Dr. Burkhard Wichert, vice president of manufacturing for Baxter's BioPharma Solutions business. "Through this expansion in Halle, Baxter will continue to support pharmaceutical companies' efforts to address patient needs worldwide."
Learn more at www.baxterbiopharmasolutions.com