Systematic development and optimization of a cIEF method for the charge variants analysis of moderately basic to basic monoclonal antibodies using the Analytical Quality by Design strategy.
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| Title: | Systematic development and optimization of a cIEF method for the charge variants analysis of moderately basic to basic monoclonal antibodies using the Analytical Quality by Design strategy. |
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| Authors: | Floris L; Department of Chemistry 'Ugo Schiff', University of Florence, Via U. Schiff 6, Sesto Fiorentino 50019, Italy., Pasquini B; Department of Chemistry 'Ugo Schiff', University of Florence, Via U. Schiff 6, Sesto Fiorentino 50019, Italy., Orlandini S; Department of Chemistry 'Ugo Schiff', University of Florence, Via U. Schiff 6, Sesto Fiorentino 50019, Italy., Luciani F; National Centre for the Control and Evaluation of Medicines (CNCF), Istituto Superiore Di Sanità, Viale Regina Elena 299, Rome 00161, Italy., Massolini G; Department of Drug Sciences, University of Pavia, Via Taramelli 12, Pavia 27100, Italy., Furlanetto S; Department of Chemistry 'Ugo Schiff', University of Florence, Via U. Schiff 6, Sesto Fiorentino 50019, Italy. Electronic address: sandra.furlanetto@unifi.it., Gotti R; Department of Pharmacy and Biotechnology, University of Bologna, Via Belmeloro 6, Bologna 40126, Italy. Electronic address: roberto.gotti@unibo.it. |
| Source: | Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 2026 Oct 15; Vol. 279, pp. 117576. Date of Electronic Publication: 2026 May 23. |
| Publication Type: | Journal Article |
| Journal Info: | Publisher: Elsevier Science Country of Publication: England NLM ID: 8309336 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-264X (Electronic) Linking ISSN: 07317085 NLM ISO Abbreviation: J Pharm Biomed Anal Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
| FullText | Text: Availability: 0 |
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| Header | DbId: mdl DbLabel: MEDLINE Ultimate An: 42190399 AccessLevel: 2 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Systematic development and optimization of a cIEF method for the charge variants analysis of moderately basic to basic monoclonal antibodies using the Analytical Quality by Design strategy. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AU" term="%22Floris+L%22">Floris L</searchLink>; Department of Chemistry 'Ugo Schiff', University of Florence, Via U. Schiff 6, Sesto Fiorentino 50019, Italy.<br /><searchLink fieldCode="AU" term="%22Pasquini+B%22">Pasquini B</searchLink>; Department of Chemistry 'Ugo Schiff', University of Florence, Via U. Schiff 6, Sesto Fiorentino 50019, Italy.<br /><searchLink fieldCode="AU" term="%22Orlandini+S%22">Orlandini S</searchLink>; Department of Chemistry 'Ugo Schiff', University of Florence, Via U. Schiff 6, Sesto Fiorentino 50019, Italy.<br /><searchLink fieldCode="AU" term="%22Luciani+F%22">Luciani F</searchLink>; National Centre for the Control and Evaluation of Medicines (CNCF), Istituto Superiore Di Sanità, Viale Regina Elena 299, Rome 00161, Italy.<br /><searchLink fieldCode="AU" term="%22Massolini+G%22">Massolini G</searchLink>; Department of Drug Sciences, University of Pavia, Via Taramelli 12, Pavia 27100, Italy.<br /><searchLink fieldCode="AU" term="%22Furlanetto+S%22">Furlanetto S</searchLink>; Department of Chemistry 'Ugo Schiff', University of Florence, Via U. Schiff 6, Sesto Fiorentino 50019, Italy. Electronic address: sandra.furlanetto@unifi.it.<br /><searchLink fieldCode="AU" term="%22Gotti+R%22">Gotti R</searchLink>; Department of Pharmacy and Biotechnology, University of Bologna, Via Belmeloro 6, Bologna 40126, Italy. Electronic address: roberto.gotti@unibo.it. – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%228309336%22">Journal of pharmaceutical and biomedical analysis</searchLink> [J Pharm Biomed Anal] 2026 Oct 15; Vol. 279, pp. 117576. <i>Date of Electronic Publication: </i>2026 May 23. – Name: TypePub Label: Publication Type Group: TypPub Data: Journal Article – Name: TitleSource Label: Journal Info Group: Src Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier+Science%22">Elsevier Science </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>8309336 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1873-264X (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2207317085%22">07317085 </searchLink><i>NLM ISO Abbreviation: </i>J Pharm Biomed Anal <i>Subsets: </i>MEDLINE |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=42190399 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1016/j.jpba.2026.117576 Languages: – Code: eng Text: English PhysicalDescription: Pagination: StartPage: 117576 Titles: – TitleFull: Systematic development and optimization of a cIEF method for the charge variants analysis of moderately basic to basic monoclonal antibodies using the Analytical Quality by Design strategy. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Floris L – PersonEntity: Name: NameFull: Pasquini B – PersonEntity: Name: NameFull: Orlandini S – PersonEntity: Name: NameFull: Luciani F – PersonEntity: Name: NameFull: Massolini G – PersonEntity: Name: NameFull: Furlanetto S – PersonEntity: Name: NameFull: Gotti R IsPartOfRelationships: – BibEntity: Dates: – D: 15 M: 10 Text: 2026 Oct 15 Type: published Y: 2026 Identifiers: – Type: issn-electronic Value: 1873-264X Numbering: – Type: volume Value: 279 Titles: – TitleFull: Journal of pharmaceutical and biomedical analysis Type: main |
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