Determination of size variants by CE-SDS for approved therapeutic antibodies: key implications of subclasses and light chain specificities

Publication date: Available online 10 February 2020Source: Journal of Pharmaceutical and Biomedical AnalysisAuthor(s): Elsa Wagner, Olivier Colas, Stéphane Chenu, Alexandre Goyon, Amarande Murisier, Sarah Cianferani, Yannis François, Szabolcs Fekete, Davy Guillarme, Valentina D’Atri, Alain BeckAbstractIn the present work, a generic non-reducing capillary electrophoresis sodium dodecyl sulphate (nrCE-SDS) method was tested for a wide range of 26 FDA and EMA approved monoclonal antibodies (mAbs) and 2 antibody drug conjugates (ADCs) as well as for the NISTmab, in a QC environment (e.g. testing quality requirements for batch manufacturing or batch release). This method allows obtaining rapidly and accurately the amount of size variants in drug products within about 40 minutes and may be used for batch release and consistency as well as for stability and shelf-life. First, the method repeatability was found to be excellent in terms of relative migration times and relative proportions of fragments (average RSD values of 0.3 and 0.2%, on relative migration times and relative percentages of fragments, respectively), thanks to the addition of an internal standard. A panel of chimeric, humanized and human mAbs were tested, belonging to different subclasses (heavy chain gamma 1, 2, 2/4 and 4) and light chain types (κ or λ) and produced in different cell lines (CHO, NS0 and SP2/0). For all these biopharmaceutical products, the amount of H2L2 species was comprised between 90.9% a...
Source: Journal of Pharmaceutical and Biomedical Analysis - Category: Drugs & Pharmacology Source Type: research