Authors
Stephen Byrn, Maricio Futran, Hayden Thomas, Eric Jayjock, Nicola Maron, Robert F Meyer, Allan S Myerson, Michael P Thien, Bernhardt L Trout
Publication date
2015/3
Source
Journal of pharmaceutical sciences
Volume
104
Issue
3
Pages
792-802
Description
We describe the key issues and possibilities for continuous final dosage formation, otherwise known as downstream processing or drug product manufacturing. A distinction is made between heterogeneous processing and homogeneous processing, the latter of which is expected to add more value to continuous manufacturing. We also give the key motivations for moving to continuous manufacturing, some of the exciting new technologies, and the barriers to implementation of continuous manufacturing. Continuous processing of heterogeneous blends is the natural first step in converting existing batch processes to continuous. In heterogeneous processing, there are discrete particles that can segregate, versus in homogeneous processing, components are blended and homogenized such that they do not segregate. Heterogeneous processing can incorporate technologies that are closer to existing technologies …
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