| Sumario: | Small-scale end-to-end systems Innovators are prototyping other mobile manufacturing facilities using continuous, end-to-end manufacturing at small scales of finished drug forms for both small- and large-molecule drugs. The call for reshoring manufacturing may be answered in part by using these advanced technologies to produce APIs or to continuously manufacture drug products endto-end, beginning with basic raw materials and ending with a finished drug form. Continuous path for OSD drugs While FDA has approved one API made using continuous flow chemistry, continuous manufacturing - starting with API and excipients and ending with finished drug - is now being used to produce six FDA-approved oral solid-dosage (OSD) drugs, including some previously made in batch manufacturing as well as new drugs approved with continuous OSD processes. The commercial facility will have a capacity that is several times greater than that of the pilot line, with two end-to-end lines that will have the capacity to produce multiple APIs and drug products, including both sterile injectables and OSD drugs using a "multi-suite" design.
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