Baxter Expands Cytotoxic Contract Manufacturing in Germany
Baxter’s BioPharma Solutions is expanding its cytotoxic contract manufacturing facility in Halle (Westfalen), Germany, to meet client needs. Such efforts mark its third capacity expansion, further enhancing Halle’s complete range of resources to support early-phase drug formulation through commercial scale-up, introduction, and lifecycle management. Baxter reports in a press release that the expansion, which will be completed by next month, "has been designed to meet international manufacturing and regulatory requirements and will be followed by an additional phase of expansion to be completed by 2012."
According to the press release, the expansion includes upgrades across multiple specialized capabilities offered at the Halle facility. A large-scale lyophilization unit was added to increase freeze-drying capacity, which supports a large majority of the Halle manufacturing business.
To support large-scale production service needs for commercially marketed oncology drugs, part of the expansion project included replacing existing filling technology with a newer system, which will allow for a more than 50% increase in capacity for commercial cytotoxic manufacturing. The filling process uses advanced cRABS (closed Restricted Access Barrier System) technology for enhanced product sterility and operator safety. Baxter recently received the prestigious “Most Effective Scale-Up/Technical Transfer Award” at the 2009 European Outsourcing Awards for this project. The project was recognized for avoiding installation delays and maintaining manufacturing timelines to meet all client obligations during the expansion.
Baxter also supports small-scale production, which is primarily used in clinical production, when clients are studying and seeking regulatory approval for new drugs. The facility now features a hand-fill suite, which is able to manufacture these small-scale clinical cytotoxic batches.
Another new Halle capability is commercial-scale production of cytotoxic emulsions, liposomes and suspensions, with the addition of a nanoparticle suite equipped with a high pressure homogenizer. These technologies allow Baxter to stay at the forefront of parenteral cytotoxic manufacturing.
“By offering a full complement of services in one location to support oncology drug production needs, we are able to meet clients’ growing needs for cytotoxic manufacturing in a single location, including early-to-late stage support to fully engage and service our clients throughout the lifecycle of their products,” said Dr. Burkhard Wichert, vice president of manufacturing for Baxter’s Halle facility, in the press release.
With more than 50 years of experience, the facility offers capabilities including 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.