FDA Acquires GEA Development Unit for Continuous Manufacturing

The US Food and Drug Administration (FDA) has purchased from GEA, a Düsseldorf, Germany-headquartered equipment manufacturer, a ConsiGma 1 OSD development unit, to be housed in the FDA’s Center for Drug Evaluation and Research (CDER)/Office of Pharmaceutical Quality (OPQ) for continuous manufacturing purposes.

The ConsiGma 1 will be an asset for continuous manufacturing research within the OPQ Office of Testing and Research and Emerging Technologies Team, according to GEA. Established in 2015, the OPQ encourages and supports development and adoption of emerging technology to modernize pharmaceutical development and manufacturing.

The GEA ConsiGma 1 is designed to enable development of granules following Quality-by-Design principles via Design of Experiments approaches with controlled continuous operation, which provides an opportunity to explore a range of process parameters, according to GEA.

Source: GEA


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