A critical evaluation of self-interaction chromatography as a predictive tool for the assessment of protein-protein interactions in protein formulation development: a case study of a therapeutic monoclonal antibody

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V
Virginie Le BrunPatrick Garidel

Abstract

The aim of this study was to establish and evaluate a screening method for the physical characterization of protein-protein interactions of therapeutic proteins based on the determination of the osmotic second virial coefficient (B(22)). B(22) of an IgG1 was measured by self-interaction chromatography (SIC) and was compared to data obtained from static light scattering (SLS). As assessed by Fourier transform infrared spectroscopy (FTIR), the protein coupling to chromatography particles had no relevant influence on the three-dimensional native structure of the IgG1. B(22) variations could be measured for physiological relevant excipient concentrations. Significant positive B(22) values were observed for the following solution conditions of the investigated antibody: (i) acidic pH conditions, (ii) low buffer concentrations, (iii) low salt concentrations and (iv) high amino acid concentrations. B(22) was compared to IgG1 stability data derived from a study conducted for 12weeks at 40 degrees C. A concentration of 5mM histidine, which was the most promising buffer candidate according to B(22), showed a slightly better physical stability (as assessed by turbidity and size exclusion chromatography) compared to the other tested formul...Continue Reading

Citations

Sep 12, 2014·Journal of Pharmaceutical Sciences·Steven B GengPeter M Tessier
Jan 8, 2013·Biologicals : Journal of the International Association of Biological Standardization·Alejandro Arbesú ValdiviaSaroj Kumar
Aug 14, 2015·Pharmaceutical Research·S H M HedbergJ M Liddell
Aug 12, 2015·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·A Quigley, D R Williams
Feb 17, 2015·Biotechnology Progress·Natalie RakelJuergen Hubbuch
Sep 3, 2013·Biotechnology and Bioengineering·Elaheh BinabajiAndrew L Zydney
Jan 8, 2014·Pharmaceutical Development and Technology·Patrick GaridelMichael Wagner
Apr 30, 2013·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·A QuigleyD R Williams
Apr 25, 2016·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Julia GrossPatrick Garidel
Jul 28, 2016·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Fabian BickelHans Kiefer
Nov 30, 2016·Journal of Pharmaceutical Sciences·Teddy J ZbacnikMark Cornell Manning
Jan 13, 2015·Journal of Biomolecular Screening·Vladimir I RazinkovGerald W Becker
Apr 26, 2018·Biotechnology Progress·Silvia M PirrungMarcel Ottens
Jul 10, 2013·Culture, Medicine and Psychiatry·Neil Krishan AggarwalRoberto Lewis-Fernández
Aug 23, 2019·Adsorption : Journal of the International Adsorption Society·S H M HedbergD R Williams
Mar 22, 2020·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Ruben WälchliPaolo Arosio
May 29, 2021·Physical Chemistry Chemical Physics : PCCP·Srdjan PusaraMariana Kozlowska
Feb 16, 2018·Analytical Chemistry·Sarah H M HedbergDaryl R Williams
Feb 6, 2017·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·James I AusterberryRobin Curtis

❮ Previous
Next ❯

Related Concepts

Related Feeds

Bacterial Cell Wall Structure (ASM)

Bacterial cell walls are made of peptidoglycan (also called murein), which is made from polysaccharide chains cross-linked by unusual peptides containing D-amino acids. Here is the latest research on bacterial cell wall structures.

Bacterial Cell Wall Structure

Bacterial cell walls are made of peptidoglycan (also called murein), which is made from polysaccharide chains cross-linked by unusual peptides containing D-amino acids. Here is the latest research on bacterial cell wall structures.