Facility of the Year Awards, An ISPE Program

2016 Facility of the Year Awards Category Winner for Operational Excellence:  Baxter BioPharma Solutions

Baxter Completes Capacity Expansion at Halle, Germany Facility to Support BioPharma Solutions’ Oncology Contract Manufacturing Services

Baxter BioPharma Solutions ExteriorBaxter BioPharma Solutions is ISPE’s 2016 Facility of the Year Awards Category Winner for Operational Excellence for their Oncology Manufacturing Expansion project located in Halle, Germany.
Baxter International Inc.’s BioPharma Solutions is a premier contract manufacturing organization (CMO) specializing in parenteral pharmaceuticals. In November 2015, they completed an approximately 1,800 square meter capacity expansion designed for oncology drugs at the company’s fill/finish contract manufacturing facility in Halle (Westfalen), Germany. The additional capacity reinforces BioPharma Solutions’ leadership position as one of the largest capacity CMOs for freeze-dried (lyophilized) cytotoxic (having a toxic effect on cells) parenterals. Cytotoxic therapies like the ones manufactured at Halle continue to be at the center of oncology treatment programs.

“Cancer incidence continues to rise, and this completed expansion offers not only capacity but innovative processes and technologies that will allow Baxter to stay at the forefront of parenteral manufacturing for oncology therapies,” said Dr. Burkhard Wichert, Vice President of Manufacturing for Baxter’s BioPharma Solutions business.  “We take seriously our commitment to world-class contract manufacturing of oncology products, and understand that the better we can serve our customers, the better they can serve patients around the world.”

Baxter BioPharma Solutions FacilityThe updated facility was designed by engineers with extensive experience in sterile manufacturing as an evolution of the reliable processes and equipment on-site. This includes new equipment combined with innovative disinfection systems and an optimized layout to improve efficiency, prevent contamination and keep potential losses on the filling line to a minimum. Extensive use of glass throughout the expansion area significantly improves visibility for workers and visitor. The ongoing development of the Halle facility is the latest in a series of recent expansions that took place in 2007 and 2011 and the addition of a new packaging line in 2013 designed to meet advanced packaging requirements of pharmaceuticals worldwide. “Our recent facility upgrades support early-phase drug formulation through commercial scale-up, product launch and lifecycle management,” said Dr. Wichert. “This most recent expansion will enable us to meet customers’ demands for flexibility, product quality and high yield while accommodating future needs.”

Halle Facility Capabilities
Baxter BioPharma Solutions FacilityBaxter’s Halle facility has a wide range of parenteral manufacturing expertise including commercial-scale production of small molecules, biologics, antibodydrug-conjugates, emulsions, liposomes and suspensions. The site is equipped with state-of-the-art technology and is one of the most advanced facilities for contract manufacturing of parenteral oncology drugs in the world. With more than 60 years of experience, the facility’s capabilities include process development, aseptic filling and lyophilization of oncologic and other sophisticated parenterals in clinical and commercial batch sizes, sterile crystallization of cytotoxic active pharmaceutical ingredients and sterile powder filling of vials.

ISPE congratulates the Baxter team for the successful completion of their project and for their win for Operational Excellence. Learn more Baxter’s award winning facility.

Join ISPE and prominent industry leaders as we recognize the 2016 Facility of the Year Awards (FOYA) Category Winners for their innovation and creativity in pharmaceutical and biotechnology facility design, construction and operation at the FOYA Banquet on the evening of Tuesday, 7 June 2016 in North Bethesda, MD during the ISPE/FDA/PQRI Quality Manufacturing Conference.