Continuous Manufacturing of Solid Dosage Forms
In partnership with its core industrial member companies, the NSF-funded Engineering Research Center (ERC) for Structured Organic Particulate Systems (C-SOPS), based at Rutgers University, has built and deployed the efficient operation of one of the first continuous direct compaction manufacturing lines in the world. The collaboration effectively transfers disruptive research in continuous pharmaceutical manufacturing of solid dosage forms to the immediate commercial sphere.
Industrial partners working with C-SOPS researchers have jointly developed and demonstrated the feasibility of new methodologies and tools for continuous pharmaceutical manufacturing. The continuous direct compaction line put into use by CSOPS’ industrial first adopters and regulators can also be used by contract manufacturers to enable the application of continuous manufacturing methods in a wide range of other industries.
Partnerships with C-SOPS member companies have helped to translate research testbed developments in continuously manufactured solid dosages directly into commercial activity through both process and product development projects. The collaboration enabled an integrated closed-loop control of the continuous direct compaction line; a Quality by Design (QbD) approach for the simultaneous development and optimization of formulation and process variables; and an integrated dynamic flowsheet model of continuous manufacturing lines in three major modes of operation (DC, WG, DG). The overall effort has helped to enable the commercial implementation of continuous manufacturing systems across the industrial sector more quickly.
