The expansion will cover more than 25,000 sq ft, which includes 8,500 sq ft of production space
Piramal’s Pharma Solutions business has announced plans to expand its Michigan facility with additional capacity and capabilities for APIs. The company is investing $32m in the facility to keep up with expected demand based on current forecasts, including potential new opportunities.
Capacity will increase in large-scale manufacturing with the addition of reactors capable of handling up to 4000 L. Piramal is also adding two kilo labs for process development and GMP manufacture for clinical trials at scales up to 100 L. Equipment in the expansion includes a 1 m2 filter dryer with glovebox technology, 3 /4 KL mild steel glass lined reactor and 3 KL Hastelloy reactor, all designed to handle potent compounds with OELs >1 mcg/m3.
Facility design procedures are designed to assure appropriate safety measures, including controlled room pressurisations with air locks for safe movement of both people and materials, glovebox technology/contained systems for charging and discharging of potent compounds, and a scrubber to address any reaction off-gassing.
The expansion is planned to be ready by Summer 2022. Its expected to add approximately twenty hires to the site.
The Riverview facility has been subject to FDA inspections along with many from European and Asian government agencies.
Peter DeYoung, CEO, Piramal Pharma Solutions said: “[The expansion] enables us to support our customers’ immediate and long-term API needs, strengthens our presence in North America, and enhances our ability to serve patients around the world by delivering the best active ingredients in a timely manner.”