A Comparative Structural and Bioanalytical Study of IVIG Clinical Lots(360 views) Sandomenico A, Severino V, Chambery A, Focà A, Focà G, Farina C, Ruvo M
Keywords: Biacore, Circular Dichroism, Ivig, Protein A, Thermal Denaturation, Electrophoresis, Industrial Engineering, Production Engineering, Quality Control, Surface Plasmon Resonance, Immunoglobulin, Analytical Research, Article, Qualitative Analysis, Quantitative Analysis, Two Dimensional Electrophoresis, Drug Contamination, Two-Dimensional, Humans, Immunoglobulin Fc Fragments, Intravenous, Protein Binding, Protein Stability,
Affiliations: *** IBB - CNR ***
Istituto di Biostrutture e Bioimmagini, Consiglio Nazionale Delle Ricerche, via Mezzocannone, 16, 80134 Naples, Italy
CIRPeB, via Mezzocannone 16, 80134 Naples, Italy
Dipartimento di Scienze e Tecnologie Ambientali Biologiche e Farmaceutiche, via A. Vivaldi 43, 81100 Caserta, Italy
Kedrion SpA, Loc. Ai Conti, 55051 Lucca Castelvecchio Pascoli, Italy
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A Comparative Structural and Bioanalytical Study of IVIG Clinical Lots
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.
A Comparative Structural and Bioanalytical Study of IVIG Clinical Lots