title: Evaluation of capillary zone electrophoresis for the determination of protein composition in therapeutic immunoglobulins and human albumins.
abstract: Capillary zone electrophoresis (CZE) provides an alternative means of separating native proteins on the basis of their inherent electrophoretic mobilities. The major advantage of CZE is the quantification by UV detection, circumventing the drawbacks of staining and densitometry in the case of gel electrophoresis methods. The data of this validation study showed that CZE is a reliable assay for the determination of protein composition in therapeutic preparations of human albumin and human polyclonal immunoglobulins. Data obtained by CZE are in line with "historical" data obtained by the compendial method, provided that peak integration is performed without time correction. The focus here was to establish a rapid and reliable test to substitute the current gel based zone electrophoresis techniques for the control of protein composition of human immunoglobulins or albumins in the European Pharmacopoeia. We believe that the more advanced and modern CZE method described here is a very good alternative to the procedures currently described in the relevant monographs.
authors.affiliation: Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Str. 51-59, 63225 Langen, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Christians
authors.affiliation: Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Str. 51-59, 63225 Langen, Germany. Electronic address: nadine.vantreel@pei.de.
authors.forename: Nadine Denise
authors.initials: ND
authors.lastname: van Treel
authors.affiliation: Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Str. 51-59, 63225 Langen, Germany. Electronic address: gabriele.bieniara@pei.de.
authors.forename: Gabriele
authors.initials: G
authors.lastname: Bieniara
authors.affiliation: Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Str. 51-59, 63225 Langen, Germany. Electronic address: annika.eulig-wien@pei.de.
authors.forename: Annika
authors.initials: A
authors.lastname: Eulig-Wien
authors.affiliation: Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Str. 51-59, 63225 Langen, Germany. Electronic address: kay-martin.hanschmann@pei.de.
authors.forename: Kay-Martin
authors.initials: KM
authors.lastname: Hanschmann
authors.affiliation: Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Str. 51-59, 63225 Langen, Germany. Electronic address: siegfried.giess@pei.de.
authors.forename: Siegfried
authors.initials: S
authors.lastname: Giess
mesh_terms: D019075:Electrophoresis, Capillary / Q000295:instrumentation* / Q000379:methods*; D006801:Humans; D007136:Immunoglobulins / Q000737:chemistry* / Q000627:therapeutic use; D015203:Reproducibility of Results; D012709:Serum Albumin / Q000737:chemistry* / Q000627:therapeutic use
chemical_list: D007136:Immunoglobulins; D012709:Serum Albumin
keywords: Albumin; Capillary zone electrophoresis; European pharmacopoeia; Human serum; Immunoglobulins; Protein composition