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Simtra BioPharma Expands U.S. and European Ops to Meet Rising Demand

Grows manufacturing capabilities in Indiana and Germany.

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By: Charlie Sternberg

Associate Editor, Contract Pharma

Simtra BioPharma Solutions is advancing a dual-continent expansion aimed at boosting capacity for sterile injectable drugs as demand for complex therapies grows. The contract development and manufacturing organization, which became independent in 2023, is investing heavily in facilities in the U.S. and Germany.

At its Bloomington, Indiana site, Simtra has added a flexible clinical line for prefilled syringes and vials and is constructing a new plant with three isolator-based commercial filling lines. The company also purchased a 65-acre property nearby, with plans for at least six additional isolator lines. The first, a high-speed vial filling line with three lyophilizers for highly potent molecules such as antibody-drug conjugates, is expected to be operational in 2027.

In Halle/Westfalen, Germany, Simtra recently opened a building housing two high-speed isolator lines for syringes and vials and added a conjugation and purification suite. These investments align with the company’s focus on high-demand areas such as oncology. Simtra produces about 200 million sterile units annually and manufactures six of the 17 approved ADCs worldwide.

“Our purpose is clear: to bring vital injectable products to customers and their patients worldwide,” said Franco Negron, CEO, Simtra BioPharma Solutions. “By expanding capacity and service offerings in both the United States and Europe, we are building the infrastructure needed to support innovation and reliability, now and for the future.”

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