September 06, 2011 -- In an effort to meet the growing demand for cytotoxic manufacturing and to support commercial scale-up and manufacturing services, Baxter’s BioPharma Solutions business has completed its latest capacity expansion at the company’s cytotoxic contract manufacturing facility in Halle/Westfalen, Germany.
The primary component of the expansion was the modular installation of an additional large-scale, commercial lyophilization unit for increasing freeze drying capacity to support commercial cytotoxic manufacturing capacity. The freeze dryer, which is now in operation, was designed to meet international manufacturing and regulatory requirements.
“This latest investment clearly demonstrates our commitment to meeting our clients’ increasing need for high-quality, cytotoxic drug production,” said Dr. Burkhard Wichert, vice president of manufacturing for Baxter’s Halle facility. “The expansion, which was completed ahead of schedule, will help support the continuous worldwide supply of oncology products for our customers and, ultimately, for patients who are afflicted with cancer.”
Building Upon Previous Expansions at Halle
Many of BioPharma Solutions’ clients require large-scale production services, mainly for commercially marketed oncology drugs. Last year, Baxter completed an expansion to support these needs, which included replacing the existing filling technology with a newer process that not only increased commercial cytotoxic manufacturing capacity by more than 50 percent, but incorporated advanced barrier isolator technology to promote product sterility and operator safety.
In 2006, two large-scale lyophilization units were added to freeze-dry cancer therapy drugs for Baxter’s pharmaceutical partners. That expansion incorporated innovative technologies to safely handle organic solvents including a state-of-the-art, fully automated loading cart and in-process quality analysis technology. The automated loading cart uses sensors to robotically transport cytotoxic vials from filling and to auto-load the freeze driers.
Halle Facility Capabilities
The manufacturing site in Halle is one of the most advanced facilities for cytotoxic contract manufacturing in the world. The facility’s capabilities include lyophilization; process development; aseptic filling of cytotoxic, non-cytotoxic and highly potent liquid and sterile powder vials in clinical and commercial batch sizes; and sterile crystallization of cytotoxic active pharmaceutical ingredients. For more information, please visit www.baxterbiopharmasolutions.com.
