title: A comparative structural and bioanalytical study of IVIG clinical lots.
abstract: Intravenous immunoglobulin are important bio-therapeutics used in the replacement therapy for primary and secondary immunodeficiencies, chronic inflammatory disorders and several autoimmune haematologic disorders. Currently, a number of immunoglobulin intravenous (IVIG) products have been approved by the Food and Drug Administration (FDA) and are available commercially. It is known that small differences in the manufacturing processes as well as in the formulations may affect their clinical efficacy and tolerability. Therefore, given the complexity of the multi-step process required for the isolation of IVIG from human plasma, it is necessary to ensure a rigorous quality control of final products. We show here that a set of different bioanalytical techniques can be conveniently used to comparatively characterize, at a quantitative and qualitative level, different lots of IVIG preparations and to unveil randomly occurring impurities which can also affect the overall product stability. We have used circular dichroism, surface plasmon resonance and two-dimensional electrophoresis (2DE), and have demonstrated that this combination of bioanalytical approaches is very useful to improve the quality control of antibodies and to monitor the reliability of the IVIG manufacturing process.
authors.affiliation: Istituto di Biostrutture e Bioimmagini, Consiglio Nazionale delle Ricerche, via Mezzocannone, 16, 80134 Naples, Italy. annamaria.sandomenico@gmail.com
authors.forename: Annamaria
authors.initials: A
authors.lastname: Sandomenico
authors.forename: Valeria
authors.initials: V
authors.lastname: Severino
authors.forename: Angela
authors.initials: A
authors.lastname: Chambery
authors.forename: Annalia
authors.initials: A
authors.lastname: Focà
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Focà
authors.forename: Claudio
authors.initials: C
authors.lastname: Farina
authors.forename: Menotti
authors.initials: M
authors.lastname: Ruvo
mesh_terms: D002942:Circular Dichroism; D004340:Drug Contamination; D015180:Electrophoresis, Gel, Two-Dimensional; D006801:Humans; D007141:Immunoglobulin Fc Fragments; D016756:Immunoglobulins, Intravenous / Q000737:chemistry* / Q000378:metabolism / Q000592:standards*; D011485:Protein Binding; D055550:Protein Stability; D020349:Surface Plasmon Resonance
chemical_list: D007141:Immunoglobulin Fc Fragments; D016756:Immunoglobulins, Intravenous