Simtra BioPharma Solutions has completed construction of a new production manufacturing building at its campus in Halle, Germany, significantly expanding the contract development and manufacturing organization's capacity to meet growing global demand for sterile injectable therapeutics.
The expansion adds 1,800 square meters (19,400 square feet) of production space, bringing the total production area at Simtra's Halle site to nearly 12,000 square meters (130,000 square feet). The facility currently employs 950 staff and will create an additional 150 new jobs with the expansion.
Enhanced Manufacturing Capabilities
The new facility strengthens Simtra's expertise in large-scale vial filling for both liquid and lyophilized products while introducing prefilled syringe technology to the Halle site for the first time. The expansion includes the addition of four new freeze dryers, bringing the total number at the site to 15 units. Freeze drying represents a critical process for preserving the stability of sensitive molecules.
"With this expansion in Halle, we are in a great position to help our clients accelerate development of new therapies, such as targeted cancer treatments, and deliver these critical drugs to patients sooner," said Franco Negron, CEO of Simtra BioPharma Solutions. "This state-of-the-art facility further builds out our expertise in large-scale vial filling for liquid and lyophilized products, as well as prefilled syringes, which is a new technology for our Halle site."
Strategic Growth Trajectory
The German facility expansion represents part of Simtra's broader strategy to strengthen its presence across North America and Europe in the sterile injectables field. In February 2024, the company announced a $250 million investment to expand its sterile fill/finish manufacturing campus in Bloomington, Indiana, marking one of its first major moves following Advent International's and Warburg Pincus' acquisition of Baxter's BioPharma Solutions business in October 2023.
More recently, in June 2024, Simtra announced a strategic alliance with the Life Science division of Merck KGaA, Darmstadt, Germany to assist biopharmaceutical companies seeking solutions related to antibody-drug conjugates and bioconjugates, including linker and payload manufacturing, drug product formulation development, and fill/finish services.
Addressing Industry Challenges
The expansion comes as the industry faces increasing complexity in aseptic processing for sterile injectables. According to Lidia Serina, PhD, head of Development Services at Simtra, technology transfer from molecule receipt through aseptic filling lines requires careful attention to critical process parameters and quality attributes to maintain molecular stability throughout the manufacturing process to the patient.
Simtra expects strong demand on both the prefilled syringe and vial fill/finish service lines once production begins at the new facility, demonstrating the company's position as a trusted manufacturing partner with specialized expertise in complex molecule manufacturing.