Impact of Amino Acid Excipients on icIEF Method Development in Protein Therapeutics: A Formulation-Aware Analytical Framework
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P Manandhar, N Payung, S Sapa, M Myers…
AAPS …, 2026
Springer
Accurate assessment of charge heterogeneity and isoelectric point (pI) is essential for ensuring the quality, stability, and safety of biotherapeutics throughout development and commercialization. Imaged capillary isoelectric focusing (icIEF) is the industry‑standard technique for this purpose, using a stable, linear pH gradient to accurately localize analyte peaks relative to calibrant pI markers. Although amino acids are widely used as formulation excipients for physicochemical stabilization, their potential to interfere with icIEF analyses …
