Simtra BioPharma Solutions Announces $250+ Million Investment to Expand Sterile Fill/Finish Manufacturing Site

Simtra BioPharma Solutions recently announced a $250+ million expansion of its sterile fill/finish manufacturing campus in Bloomington, IN.

A new, state-of-the-art 150,000-sq-ft building will be constructed to house two high-speed automated isolator syringe fill lines and a new high speed isolator vial line equipped with three 30 square meter lyophilizers. Each process suite in the new building will be fitted with dedicated formulation/compounding rooms. The expansion will also include the addition of a dedicated clinical line equipped to support our growing development/clinical business. This line will utilize existing facility infrastructure. The announcement of the planned expansion follows Simtra’s recent acquisition by Advent International, one of the largest and most experienced global private equity investors, and Warburg Pincus, a leading global growth investor.

The clinical line is expected to be ready to onboard new projects by summer 2025. It will provide the Bloomington campus the ability to better accommodate projects that are in early phases of development (Phase 1 or 2) and keep these projects onsite as they scale up for commercialization. Construction of the new building is planned to begin in June 2024 and anticipated to take two years to complete, allowing for GMP readiness in late 2026. In aggregate, the expansion is expected to create hundreds of new jobs in Bloomington.

“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 Antibody-Drug-Conjugates as well as overall continued growth of the oncology pipeline,” said Franco Negron, CEO of Simtra BioPharma Solutions. “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. “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.”

This latest expansion follows a $100+ million investment in Simtra’s Halle/Westfalen, Germany site in 2021 for the construction of a new building housing a high-speed syringe line and a vial line equipped with four lyophilizers. GMP readiness is anticipated by the end of 2024.

Simtra BioPharma Solutions is a premier CDMO with over 65 years of sterile injectable experience. Simtra offers world-class cGMP sterile fill/finish, development services, technical expertise, quality service, and a uniquely collaborative approach. With a commitment to excellence, the company strives to make a positive impact on the well-being of patients worldwide.