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FDA and BARDA awarded a contract to Continuus Pharmaceuticals to develop an end-to-end continuous manufacturing process for solid-dosage drugs.
Continuus Pharmaceuticals was recently awarded a $4.4-million contract by FDA and the Biomedical Advanced Research and Development Authority (BARDA). The purpose of this collaborative work, entitled “Advancement of Integrated Continuous Manufacturing (ICM) Unit Operations,” is to develop a science- and risk-based approach on how drug quality can be monitored and improved through integrated continuous manufacturing. The Continuus team will develop a fully automated, end-to-end, integrated continuous pilot plant that will be used to test relevant regulatory principles, including real-time release and traceability.
Continuus Pharmaceuticals was launched in 2012 to expand the ICM technology originally developed by the Novartis–Massachusetts Institute of Technology Center for Continuous Manufacturing. Continuus, with business partners IMA and New England Controls (a business of Emerson), has laboratory-scale equipment at its Woburn, Massachusetts facility, which it uses for process development with pharmaceutical industry partners.
Under the FDA/BARDA contract, Continuus will build a dedicated pilot-scale line at the company’s Woburn facility. The pilot-scale line will be able to run approximately 2 kg/h, which is more than 10 times the capacity of the laboratory-scale equipment. “This line will be fully dedicated to regulatory purposes, such as how to monitor quality of API in-line and real-time release of final product,” Salvatore Mascia, Continuus CEO and founder, told Pharmaceutical Technology.
The timeframe for the project is three years. The company is currently working on process development and design of the system, and Mascia anticipates that the pilot plant will be up and running in mid-2018. “At the end of the project, the system can be easily duplicated into a commercial plant for producing pharmaceuticals on demand and for producing medical countermeasures, beginning with raw materials and ending with solid-dosage drugs,” says Mascia.
Source: Continuus Pharmaceuticals