Baxter International has begun a 1,750m2 capacity expansion at its BioPharma Solutions fill/finish cytotoxic contract manufacturing facility in Halle (Westfalen), Germany.
The facility has been expanding to meet demand for cytotoxic manufacturing, further enhancing Halle's resources to support early phase drug formulation through to commercial scale-up, product launch and lifecycle management. This latest move follows previous capacity expansions in Halle in 2007 and 2011. It will increase the workforce at the plant by approximately 10%.
‘Cancer incidence is on the rise and cytotoxic therapies continue to be at the centre of oncology treatment programmes,’ said Burkhard Wichert, VP of Manufacturing at Baxter's BioPharma Solutions business. ‘Through this expansion in Halle, Baxter will continue to support pharmaceutical companies' efforts to address patient needs worldwide.’
This expansion and our advanced technologies allow Baxter to stay at the forefront of parenteral cytotoxic manufacturing
The expansion, which should be completed in 2015, 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 lines will be equipped with an automated loading/unloading, capping and inspection infrastructure. This expansion will support international manufacturing and regulatory requirements.
Baxter's Halle facility has a 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 claimed to be 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 active pharmaceutical ingredients, in addition to 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,’ added 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%.’