Baxter completes capacity expansion in Halle, Germany

Published: 31-Aug-2011

The US healthcare company has added a large-scale lyophilisation unit to meet demand for cytotoxic manufacturing

US healthcare company Baxter International has completed a capacity expansion at its BioPharma Solutions cytotoxic contract manufacturing facility in Germany.

The firm has added a large-scale, commercial lyophilisation unit at its plant in Halle/Westfalen to increase freeze-drying capacity to support commercial cytotoxic manufacturing.

‘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,’ said Burkhard Wichert, vice president of manufacturing for Baxter's Halle facility.

This latest expansion follows last year’s replacement of the existing filling technology with a newer process that not only increased commercial cytotoxic manufacturing capacity by more than 50%, but also included advanced barrier isolator technology to promote product sterility and operator safety.

In 2006, two large-scale lyophilisation units were added to freeze-dry cancer therapy drugs for Baxter's pharmaceutical partners, incorporating technologies to handle organic solvents safely, including a fully automated loading cart and in-process quality analysis technology. The automated loading cart uses sensors robotically to transport cytotoxic vials from filling and to auto-load the freeze driers.

The Halle site’s capabilities include lyophilisation; process development; aseptic filling of cytotoxic, non-cytotoxic and highly potent liquid and sterile powder vials in clinical and commercial batch sizes; and sterile crystallisation of cytotoxic active pharmaceutical ingredients.

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