Contract Manufacturing Facility in Halle Expands to Cater for Growing Cytoxics Market
Baxter International’s BioPharma Solutions business has begun an approximately 1,750 m2 capacity expansion at the company’s fill/finish cytotoxic contract manufacturing facility in Halle, Westfalen, Germany. The facility continues to grow and has been expanding to meet clients’ growing needs for cytotoxic (having a toxic effect on cells) manufacturing, further enhancing Halle’s complete range of resources to support early phase drug formulation through commercial scale-up, product launch and lifecycle management. This latest effort follows previous capacity expansions in Halle in 2007 and 2011.
“Cancer incidence is on the rise and cytotoxic therapies continue to be at the centre of oncology treatment programmes,” said Dr. Burkhard Wichert, Vice President of Manufacturing for Baxter’s BioPharma Solutions business. “Through this expansion in Halle, Baxter will continue to support pharmaceutical companies’ efforts to address patient needs worldwide.”
To support the needs of clients globally, the expansion includes the installation of a new commercial filling line with two freeze dryers, as well as a clinical filling line with an additional freeze dryer. Both the new commercial and clinical lines will be equipped with an automated loading/unloading, capping and inspection infrastructure. This expansion is expected to be complete in 2015 and has been designed to support international manufacturing and regulatory requirements.
Baxter’s Halle facility has a wide range of capabilities, including commercial-scale production of cytotoxic emulsions, liposomes and suspensions, as well as a nanoparticle suite equipped with a high pressure homogeniser. The site is equipped with barrier isolator technology and is one of the most advanced facilities for cytotoxic contract manufacturing in the world. With more than 50 years of experience, the facility’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; sterile crystallisation of cytotoxic APIs; and expertise in the manufacturing of antibody-drug conjugates.
“We believe in our customers and the patients they serve, which is why we continue to invest in the Halle, Germany facility,” said Dr. Wichert. “This expansion and our advanced technologies allow Baxter to stay at the forefront of parenteral cytotoxic manufacturing while increasing the current Halle workforce by approximately 10%.”
The Halle facility is part of Baxter’s BioPharma Solutions business, which supports leading pharmaceutical companies in meeting their commercialisation objectives by providing scientific expertise, sterile manufacturing solutions, parenteral delivery systems and customised support services needed to meet the unique challenges that parental products face.
Baxter International Inc., +1 224 948 1812, www.baxter.com / www.baxterbiopharmasolutions.com.