Advanced Manufacturing Technologies Shift Outside the Box: Intensified and distributed manufacturing approaches create flexible, local capacity.
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 adva...
| Publicado en: | Pharmaceutical Technology Europe no. 4; pp. 7 - 11 |
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| Formato: | Journal Article |
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MJH Life Sciences
Apr2021
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=149895660&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 149895660 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 17537967 5NG jtl: Pharmaceutical Technology Europe issn: 17537967 maglogo: N pubinfo: dt: Apr2021 iid: 4 pid: 54670 pub: MJH Life Sciences place: Cranbury, New Jersey artinfo: ui: 149895660 149895660 ppf: 7 ppct: 4 formats: fmt: @attributes: type: P tig: atl: Advanced Manufacturing Technologies Shift Outside the Box: Intensified and distributed manufacturing approaches create flexible, local capacity. aug: au: Markarian, Jennifer sug: ab: 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. pubtype: Trade Publication doctype: Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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