Small-Scale Syringe and Vial-Filling Capability for Development of Robust Filling Processes, Smooth Tech Transfers, and to Resolve Manufacturing Issues: Summary of Key Learnings.
Filling of syringes and vials with high-viscosity monoclonal antibodies (mAbs) or small-molecule liquid formulations is a difficult task and may present several challenges. Considerable development work may be required to develop a filling process that provides a clean fill using a small-scale or at...
| Publicado en: | BioPharm International Vol. 36; no. 7; pp. 28 - 34 |
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| Autores principales: | , , , |
| Formato: | pictorial tables/charts Journal Article |
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MJH Life Sciences
Jul2023
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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=164973775&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 164973775 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 1542166X 5NE jtl: BioPharm International issn: 1542166X maglogo: N pubinfo: dt: Jul2023 vid: 36 iid: 7 pid: 54670 pub: MJH Life Sciences place: Cranbury, New Jersey artinfo: ui: 164973775 164973775 164973775 164973775 ppf: 28 ppct: 6 formats: fmt: @attributes: type: P tig: atl: Small-Scale Syringe and Vial-Filling Capability for Development of Robust Filling Processes, Smooth Tech Transfers, and to Resolve Manufacturing Issues: Summary of Key Learnings. aug: au: HUTTER, KEVIN DESAI, KASHAPPA GOUD RUSANOV, IGOR GIDH, AARTI affil: Process Engineering and Analytics, Drug Product Development, GSK sug: subj: Syringes Equipment Design Administration, Intravenous Antibodies, Monoclonal Administration and Dosage Manufacturing Industry Equipment Failure Equipment Maintenance Product Development ab: Filling of syringes and vials with high-viscosity monoclonal antibodies (mAbs) or small-molecule liquid formulations is a difficult task and may present several challenges. Considerable development work may be required to develop a filling process that provides a clean fill using a small-scale or at-scale filling machine. However, performing the development work using an at-scale filling machine is neither an efficient nor cost-effective long-term option due to hectic manufacturing schedules and associated resource needs. A small-scale filling line can be used to define optimal filling process parameters, support technology transfer, and develop mitigation strategies for ongoing or potential issues with minimal disruption of normal manufacturing operation. Streamlined ways of working without requiring manufacturing-scale line time is expected to result in increased efficiency and improved portfolio progression timelines. Key learnings, case studies, and recommendations for this small-scale filler are discussed. pubtype: Trade Publication doctype: pictorial tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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