Baxter Enhances Capabilities Of German Cytotoxic Contract Manufacturing Facility

The expansion, which is scheduled to be completed by next month, marks Baxter’s third capacity expansion, further augmenting Halle’s complete range of resources to support early-phase drug formulation through commercial scale-up, introduction, and lifecycle management.

The facility 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. A large-scale lyophilization unit was added to increase freeze-drying capacity, which supports a majority of the Halle manufacturing business.

The expansion project also included replacing existing filling technology with a newer system, which will allow for a more than 50% increase in capacity for commercial cytotoxic manufacturing, which will cater to the large-scale production service needs for commercially marketed oncology drugs. The filling process uses advanced cRABS (closed Restricted Access Barrier System) technology for operator safety and enhanced product sterility.

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.

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.

Dr Burkhard Wichert, vice president of manufacturing for Baxter’s Halle facility, said: “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.”