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A Design of Experiments and Risk Management-Driven Analytical Platform for Charge Variant Analysis of Therapeutic Antibodies by Imaged Capillary Isoelectric Focusing.

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Title: A Design of Experiments and Risk Management-Driven Analytical Platform for Charge Variant Analysis of Therapeutic Antibodies by Imaged Capillary Isoelectric Focusing.
Authors: Ghizzani V; National Centre for the Control and Evaluation of Medicines (CNCF), Istituto Superiore Di Sanità, Viale Regina Elena 299, 00161, Rome, Italy.; Department of Drug Sciences, University of Pavia, Via Taramelli 12, 27100, Pavia, Italy., Orlandini S; Department of Chemistry 'Ugo Schiff', University of Florence, Via U. Schiff 6, 50019, Sesto Fiorentino, Italy., Ascione A; National Centre for the Control and Evaluation of Medicines (CNCF), Istituto Superiore Di Sanità, Viale Regina Elena 299, 00161, Rome, Italy., Pasquini B; Department of Chemistry 'Ugo Schiff', University of Florence, Via U. Schiff 6, 50019, Sesto Fiorentino, Italy., Tengattini S; Department of Drug Sciences, University of Pavia, Via Taramelli 12, 27100, Pavia, Italy., Temporini C; Department of Drug Sciences, University of Pavia, Via Taramelli 12, 27100, Pavia, Italy., Gotti R; Department of Pharmacy and Biotechnology, University of Bologna, Via Belmeloro 6, 40126, Bologna, Italy., Massolini G; Department of Drug Sciences, University of Pavia, Via Taramelli 12, 27100, Pavia, Italy., Furlanetto S; Department of Chemistry 'Ugo Schiff', University of Florence, Via U. Schiff 6, 50019, Sesto Fiorentino, Italy. sandra.furlanetto@unifi.it., Luciani F; National Centre for the Control and Evaluation of Medicines (CNCF), Istituto Superiore Di Sanità, Viale Regina Elena 299, 00161, Rome, Italy. francesca.luciani@iss.it.
Source: The AAPS journal [AAPS J] 2025 Dec 05; Vol. 28 (1), pp. 27. Date of Electronic Publication: 2025 Dec 05.
Publication Type: Journal Article
Journal Info: Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: A Design of Experiments and Risk Management-Driven Analytical Platform for Charge Variant Analysis of Therapeutic Antibodies by Imaged Capillary Isoelectric Focusing.
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  Data: <searchLink fieldCode="AU" term="%22Ghizzani+V%22">Ghizzani V</searchLink>; National Centre for the Control and Evaluation of Medicines (CNCF), Istituto Superiore Di Sanità, Viale Regina Elena 299, 00161, Rome, Italy.; Department of Drug Sciences, University of Pavia, Via Taramelli 12, 27100, Pavia, Italy.<br /><searchLink fieldCode="AU" term="%22Orlandini+S%22">Orlandini S</searchLink>; Department of Chemistry 'Ugo Schiff', University of Florence, Via U. Schiff 6, 50019, Sesto Fiorentino, Italy.<br /><searchLink fieldCode="AU" term="%22Ascione+A%22">Ascione A</searchLink>; National Centre for the Control and Evaluation of Medicines (CNCF), Istituto Superiore Di Sanità, Viale Regina Elena 299, 00161, Rome, Italy.<br /><searchLink fieldCode="AU" term="%22Pasquini+B%22">Pasquini B</searchLink>; Department of Chemistry 'Ugo Schiff', University of Florence, Via U. Schiff 6, 50019, Sesto Fiorentino, Italy.<br /><searchLink fieldCode="AU" term="%22Tengattini+S%22">Tengattini S</searchLink>; Department of Drug Sciences, University of Pavia, Via Taramelli 12, 27100, Pavia, Italy.<br /><searchLink fieldCode="AU" term="%22Temporini+C%22">Temporini C</searchLink>; Department of Drug Sciences, University of Pavia, Via Taramelli 12, 27100, Pavia, Italy.<br /><searchLink fieldCode="AU" term="%22Gotti+R%22">Gotti R</searchLink>; Department of Pharmacy and Biotechnology, University of Bologna, Via Belmeloro 6, 40126, Bologna, Italy.<br /><searchLink fieldCode="AU" term="%22Massolini+G%22">Massolini G</searchLink>; Department of Drug Sciences, University of Pavia, Via Taramelli 12, 27100, Pavia, Italy.<br /><searchLink fieldCode="AU" term="%22Furlanetto+S%22">Furlanetto S</searchLink>; Department of Chemistry 'Ugo Schiff', University of Florence, Via U. Schiff 6, 50019, Sesto Fiorentino, Italy. sandra.furlanetto@unifi.it.<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, 00161, Rome, Italy. francesca.luciani@iss.it.
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  Data: <searchLink fieldCode="JN" term="%22101223209%22">The AAPS journal</searchLink> [AAPS J] 2025 Dec 05; Vol. 28 (1), pp. 27. <i>Date of Electronic Publication: </i>2025 Dec 05.
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              Text: 2025 Dec 05
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