Simtra BioPharma Solutions Expands Sterile Fill/Finish Manufacturing Site

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Simtra BioPharma Solutions announced on Feb. 28, 2024 that it is investing more than $250 million to expand its sterile fill/finish manufacturing campus in Bloomington, Ind. This expansion follow’s Advent International’s and Warburg Pincus’ acquisition of Baxter’s BioPharma Solutions business in October 2023, which is now operating under Simtra BioPharma Solutions.

The expansion will include a new state-of-the-art 150,000-square-foot building that will feature two high-speed automated isolator syringe fill lines and a new high-speed isolator vial line equipped with three 30-square-meter lyophilizers. Process suites in the new building will have dedicated formulation/compounding rooms, and a dedicated clinical line will support the company’s development and clinical business.

Simtra expects construction of the new building to begin in June 2024 and be completed in late 2026. The clinical line is expected to be ready for projects by summer of 2025 and will allow the company to accommodate projects that are in Phase I or II development, keeping the projects onsite as they scale up for commercialization.

"We are experiencing a broad increase in demand and need for injectable manufacturing in therapeutic classes such as GLP-1 drugs and product categories such [as] antibody-drug-conjugates as well as overall continued growth of the oncology pipeline," said Franco Negron, CEO of Simtra BioPharma Solutions, in a press release. "Our customers consider our sites in Halle and Bloomington as an extension of their manufacturing network, so we are thrilled to further enhance our capabilities and resources to help them meet their respective goals. This expansion is the latest in a series of strategic, long-term investments to ensure that Simtra continues to grow with and for our customers."

"We are excited to back the exceptional team we have at Simtra to make the first, of what we hope is several, major growth investments as we build the leading, independent sterile injectable CDMO," said Carmine Petrone, a managing director at Advent International, and Ruoxi Chen, a managing director at Warburg Pincus, in the release. "The planned expansion is designed to meet the needs of our customers, and their patients. We're excited for the trajectory of the business, given the dynamic industry backdrop, and aim to enable Simtra's customers to deliver more doses of life sustaining therapies to patients."

Simtra BioPharma Solutions is an injectable contract development and manufacturing organization that provides current good manufacturing practice (GMP) sterile fill/finish and development services. In 2021, the company, operating as Baxter BioPharma Solutions, also invested more than $100 million to expand its Halle/Westfalen, Germany site to include a high-speed syringe line and a vial line equipped with four lyophilizers. The company expects that the expansion will be GMP ready by the end of 2024.

Source: Simtra BioPharma Solutions