Simtra BioPharma Solutions (Simtra) will expand its manufacturing campus in Bloomington, Indiana, US, with an aseptic manufacturing and filing facility.
The project will enhance the site’s capacity for producing sterile fill/finish injectables and lyophilisation, as well as supporting their clinical-scale production.
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The company will invest more than $250m in the expansion. The project has garnered support from local authorities, including the Bloomington Economic Development Corporation (BEDC) and the Indiana Economic Development Corporation (IEDC).
The ground-breaking ceremony for the project was held in June 2024. A new clinical line will be added as part of the expansion, which is slated to begin integrating new products by 2025.
The development will equip the Bloomington campus with the necessary infrastructure to manage projects in their initial stages of development.
The facility is anticipated to meet good manufacturing practices (GMP) standards by the latter part of 2026.
The site is expected to create more than 130 new employment opportunities in the Bloomington area upon its completion.
Location of Simtra鈥檚 manufacturing campus
The expansion will occur within Simtra’s existing main campus at 927 South Curry Pike in Monroe County, Bloomington.
The new building will become a new focal point for the Bloomington site due to its strategic location on a prominent road near the main entrance, enhancing the site’s visibility and accessibility.
Simtra BioPharma Solutions鈥� Bloomington site expansion details
The site will be expanded with a new state-of-the-art building (Building H) covering an area of 150,000ft虏 (13,935m虏).
The facility will be equipped with three additional filling lines, including two 600 unit/min Bausch and Strobel high-speed automated isolator pre-filled syringe fill lines and a 400 unit/min IMA high-speed isolator vial line, which will be complemented by three 30m虏 LYOMAX 30 聽lyophilisers with automated loading and unloading systems.
The production facilities will be situated on the first floor, which will have a gross floor area of 75,000ft虏. The laboratory and office space will be situated on the second floor.
Each process suite within the new building will be equipped with its own dedicated formulation and compounding rooms.
Additionally, the expansion will introduce a dedicated clinical line, designed to assist the company鈥檚 growing development and clinical business. The line will capitalise on the existing infrastructure of the facility, thereby optimising resource utilisation.
Existing Bloomington campus details
The Bloomington campus, encompassing an area of around 600,000ft虏, serves as a contract manufacturer of sterile products. It specialises in aseptic formulation for prefilled syringes, as well as liquid and lyophilised vials.
It houses various research and development (R&D) scientists and a lyophilisation centre of excellence, facilitating formulation, development, and the rapid transfer of technology.
Financing details
The Monroe County Council approved a tax break of nearly $10.4m for the expansion project in March 2024.
Contractors involved
JacobsWyper Architects is responsible for designing the architecture of the facility while F A Wilhelm Construction is taking up the construction work of the facility.
Other companies involved in the project are Counterpoint Development, a construction management company; Kimley-Horn, a planning and design consulting company; and Integrated Project Services (IPS), a pharmaceutical project management company.
Marketing commentary on Simtra Biopharma Solutions
Simtra Biopharma Solutions is an independent end-to-end contract development and manufacturing organisation (CDMO) based in the US. It offers a range of services for customers, from clinical development to commercial fill/finish.
The global investment companies Advent International and Warburg Pincus acquired Baxter International’s BioPharma Solutions (BPS) business in October 2023. Following the acquisition, the business was rebranded as Simtra BioPharma Solutions.
Simtra鈥檚 areas of expertise include the production of injectables, the optimisation of lyophilisation processes, the handling of cytotoxic and highly potent compounds, as well as the development and manufacturing of biologics, small molecules, and diluents for reconstitution.
With approximately 1,700 employees, Simtra operates manufacturing facilities in Bloomington, Indiana, US; and Halle/Westfalen, Germany. The company’s client base distributes to more than 120 countries worldwide.
In addition to its investment in the Bloomington site, Simtra also invested $100m in the construction of a new building at its Halle/Westfalen site in 2021.
