Baxter BioPharma Solutions Expands Lyophilization Capacity In Halle, Germany

New Technology and Additional Lyophilization Chambers Support Cytotoxic Contract Manufacturing Business

Deerfield, IL - Baxter Healthcare Corporation announced a lyophilization capacity expansion at its Halle, Germany, facility to support future growth of Baxter BioPharma Solutions (BPS) cytotoxic contract manufacturing business.

Two large-scale lyophilization chambers will be added to freeze-dry cancer therapies for the company's pharmaceutical and biotechnology partners. Baxter expects the expansion to be completed and fully validated by mid-2007.

"We are expanding to meet the growing demands of the cytotoxic manufacturing market," said Tom Polen, senior director of marketing for Baxter's BioPharma Solutions business. "As a leader in the industry, we look forward to providing greater capacity and continuing to advance our track record for delivering safe, high-quality products for our customers."

The new lyophilization chambers will include innovative technologies (e.g. handling of organic solvents) designed to optimize product quality and safety, while reducing risk of compromising product integrity. An automated vial loading system and new in-process quality analysis technology will provide advanced control over the manufacturing process to help ensure the highest quality product is produced.

The manufacturing site in Halle, Germany, is one of the most advanced facilities for cytotoxic, or anti-cancer drug, contract manufacturing in the world. With more than 50 years of experience, the Halle facility's capabilities include lyophilization, aseptic filling of liquid and sterile powder vials, and sterile crystallization. Baxter BioPharma Solutions uses a proprietary vial washing process that has been shown to nearly eliminate external surface contamination of chemotherapy vials, reducing exposure of healthcare workers to hazardous cytotoxic drugs. All products made in Halle, including those made in the new freeze-drying chambers, benefit from this method.

Because the volatile nature of cytotoxic molecules requires dedicated facilities and technical expertise, many companies seek specialized manufacturers such as Baxter BioPharma Solutions for production of their cytotoxic drugs. Industry estimates predict that 65 percent of cytotoxic drugs will be outsourced compared to only 30 percent of non-cytotoxic products.

SOURCE: Baxter Healthcare Corporation