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

•Therapeutic antibodies size-variants are CQAs that have to be assessed.•A generic nrCE-SDS method was successfully developed and applied for this scope.•A wide panel of antibodies having different features was investigated.•Several case studies, including originator/biosimilar comparison, were repo...

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Veröffentlicht in:	Journal of pharmaceutical and biomedical analysis 2020-05, Vol.184, p.113166, Article 113166
Hauptverfasser:	Wagner, Elsa, Colas, Olivier, Chenu, Stéphane, Goyon, Alexandre, Murisier, Amarande, Cianferani, Sarah, François, Yannis, Fekete, Szabolcs, Guillarme, Davy, D’Atri, Valentina, Beck, Alain
Format:	Artikel
Sprache:	eng
Schlagworte:	Antibodies, Monoclonal - chemistry Antibodies, Monoclonal - therapeutic use Antibodies, Monoclonal, Humanized - chemistry Antibodies, Monoclonal, Humanized - therapeutic use Antineoplastic Agents, Immunological - chemistry Antineoplastic Agents, Immunological - therapeutic use CE-SDS Chemical Sciences Electrophoresis, Capillary - methods Humans Immunoconjugates - chemistry Immunoconjugates - therapeutic use Immunoglobulin Light Chains - chemistry Immunoglobulin Light Chains - metabolism Low molecular weight species Pharmacopeia method Quality control Size variants Sodium Dodecyl Sulfate - chemistry
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