Injectable contract development and manufacturing organisation (CDMO) Simtra BioPharma Solutions has announced plans to make an investment exceeding $250m for an expansion of its sterile fill/finish manufacturing site in Bloomington, Indiana, US.
The move is aimed at meeting the rising demand for development services and bolstering clinical and commercial manufacturing capabilities.
The new 150,000ft² facility will feature two high-speed automated isolator syringe fill lines and a new isolator vial line with three 30m² lyophilisers.
Each process suite will have dedicated formulation/compounding rooms.
The expansion also includes a dedicated clinical line to support the growing development and clinical business of the CDMO and leverage the existing infrastructure of the facility.
The clinical line is expected to commence onboarding new projects by summer 2025, providing the Bloomington campus with the expertise to better manage early-stage development projects (Phase I or II) and maintain these projects on-site as they progress towards marketing.
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Construction of the facility is scheduled to commence in June 2024 and is expected to be completed and achieve good manufacturing practice (GMP) readiness by late 2026.
The expansion will generate a number of job openings in the Bloomington area.
The development comes after Simtra was acquired by Advent International and Warburg Pincus.
The Bloomington site’s expansion is a continuation of Simtra’s investment strategy, which included $100m invested in 2021 at its Halle/Westfalen, Germany site for a new building equipped with a high-speed syringe line.
The facility will also have a vial line along with four lyophilisers, aiming for GMP readiness by the end of 2024.
Simtra BioPharma Solutions CEO Franco Negron stated: “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 the overall continued growth of the oncology pipeline.
“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.”
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