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
Description
ISSN:1550-7416
DOI:10.1208/s12248-025-01178-8