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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Bibliographic Details
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.
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
Description
ISSN:1873-264X
DOI:10.1016/j.jpba.2026.117576