Simtra BioPharma Solutions expands global manufacturing footprint to advance the future of sterile injectables

PARSIPPANY, N.J., Oct. 27, 2025 /PRNewswire/ -- Simtra BioPharma Solutions, a leading contract development and manufacturing organization (CDMO) specializing in sterile injectables, is making progress on a dual-continent expansion strategy to meet growing global demand for complex, high-value therapies. Since becoming an independent company in 2023, Simtra has accelerated its growth across North America and Europe, reinforcing its commitment to building advanced capacity and capabilities in both regions.

In the United States at its site in Bloomington, Indiana, Simtra has added a flexible clinical line for prefilled syringes and liquid and lyophilized vials and is building a new production facility that will house three isolator commercial-scale sterile filling lines. The company also acquired a 65-acre property nearby with more than 300,000 square feet of available space for future development. Plans for this campus include the installation of at least six additional isolator filling lines. The first new line will be a high-speed isolator vial filling line equipped with three lyophilizers dedicated to highly potent molecules, such as antibody-drug conjugates (ADCs), and is scheduled to be operational in 2027.

Simtra's expansion in Halle/Westfalen, Germany, continues in parallel. The company recently added a state-of-the-art conjugation and purification suite and inaugurated a new building with two new high-speed isolator lines, one for syringes and one for liquid and lyophilized vials. These investments reflect Simtra's global strategy to deliver high-quality sterile manufacturing solutions across key markets. 

"Our purpose is clear: to bring vital injectable products to customers and their patients worldwide," said Franco Negron, chief executive officer, 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."

Simtra's growth strategy is closely aligned with high-demand therapeutic areas such as oncology medicines. The company produces nearly 200 million sterile units annually across its facilities and currently manufactures six of the 17 approved ADCs globally.

A key differentiator for Simtra is its matched capabilities in North America and the European Union, enabling customers to build resilient, end-to-end supply chains in their target markets. The company's integrated development services, including formulation and lyophilization development and its technology transfer capabilities, support clients from pre-commercial stages through full-scale launch and beyond. 

With more than 65 years of sterile manufacturing expertise and the agility of a newly independent company, Simtra is uniquely positioned to combine deep technical knowledge with a forward-looking approach to innovation and growth.

"Our integrated approach, cross-functional expertise, and continuity of project management help accelerate readiness for commercialization," added Negron. "From the outset, products are designed for high-quality manufacturing to maximize yields and facilitate scalability, saving time and money."

About Simtra BioPharma Solutions

Simtra BioPharma Solutions is a global contract development and manufacturing organization (CDMO) focused exclusively on sterile injectables. With more than 65 years of manufacturing expertise, Simtra combines deep technical know-how, global reach and a strong quality record to help pharma and biotech innovators bring complex medicines to patients. Simtra operates facilities in Bloomington, Indiana, USA, and Halle/Westfalen, Germany. 

For more information, visit www.simtra.com.

SOURCE Simtra BioPharma Solutions