- Simtra BioPharma Solutions is expanding its sterile injectable manufacturing capacity across sites in the United States and Germany as part of a dual-continent growth strategy.
- The company plans to add multiple new isolator filling lines and advanced facilities to support production of complex molecules, including antibody-drug conjugates (ADCs), with new operations coming online from 2027.
Simtra BioPharma Solutions, a contract development and manufacturing organisation (CDMO) specialising in sterile injectables, is advancing its global expansion programme to meet growing demand for complex, high-value therapies. Since becoming independent in 2023, the company has accelerated its investments across North America and Europe.
At its Bloomington, Indiana site in the United States, Simtra has added a flexible clinical line for prefilled syringes and vials and is constructing a new production facility that will include three commercial-scale isolator filling lines. The company has also acquired a 65-acre property nearby with over 300,000 square feet of space for future development, including plans for six additional isolator lines. The first of these, a high-speed vial filling line with three lyophilizers dedicated to highly potent molecules such as ADCs, is expected to begin operations in 2027.
In Halle/Westfalen, Germany, Simtra has expanded its European capabilities with a new conjugation and purification suite and two additional high-speed isolator lines for syringes and vials. These investments reflect the company’s strategy to provide robust, high-quality sterile manufacturing solutions across major global markets.
“Our purpose is clear: to bring vital injectable products to customers and their patients worldwide. 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.”
Franco Negron, Chief Executive Officer of Simtra BioPharma Solutions
Simtra produces around 200 million sterile units annually and manufactures six of the 17 approved ADCs globally. With matched capabilities across North America and the EU, the company aims to help customers establish resilient, end-to-end supply chains supported by integrated formulation, lyophilization, and technology transfer services.
