Acetate- and Citrate-Specific Ion Effects on Unfolding and Temperature-Dependent Aggregation Rates of Anti-Streptavidin IgG1

Journal of Pharmaceutical Sciences
Gregory V BarnettChristopher J Roberts

Abstract

Controlling and predicting unwanted degradation, such as non-native aggregation, is a long-standing challenge for mAbs and other protein-based products. mAb aggregation rates are typically sensitive to temperature, pH, and the addition of excipients. Quantitatively comparing temperature-dependent aggregation rates across multiple possible formulations is a challenge in product development. A parallel temperature initial rate method is used to efficiently and accurately determine initial rates for anti-streptavidin (AS) IgG1 aggregation as a function of pH, [NaCl], and in the presence of acetate versus citrate buffer. Parallel temperature initial rates are shown to agree with results from a traditional, isothermal method and permits direct comparison of the formulations across almost 3 orders of magnitude of aggregation rates. The apparent midpoint unfolding temperatures (through differential scanning calorimetry) and the effective activation energy values (Ea) are generally higher in acetate buffer compared with citrate buffer, which is consistent with preferential accumulation of citrate ions compared with acetate ions that was speculated in previous work (Barnett et al., J Phys Chem B, 2015). Static light scattering and Kirkw...Continue Reading

References

Nov 1, 1987·Biopolymers·W J Becktel, J A Schellman
Dec 7, 1982·Biochemistry·T Arakawa, S N Timasheff
Oct 1, 1996·Biophysical Journal·R L Baldwin
Aug 1, 1997·Protein Engineering·A V Finkelstein
Apr 30, 2003·Protein Science : a Publication of the Protein Society·Eva Y ChiTheodore W Randolph
Oct 10, 2006·The AAPS Journal·Amy S Rosenberg
Jun 19, 2007·The Journal of Physical Chemistry. B·Jennifer M Andrews, Christopher J Roberts
Aug 28, 2007·Journal of Pharmaceutical Sciences·Roxana M IonescuMarc Kirchmeier
Aug 8, 2008·Journal of Pharmaceutical Sciences·William F WeissChristopher J Roberts
Jun 6, 2009·Nature Structural & Molecular Biology·F Ulrich Hartl, Manajit Hayer-Hartl
May 4, 2010·Biopharmaceutics & Drug Disposition·Weirong Wang, Thomayant Prueksaritanont
Apr 12, 2011·Biotechnology and Bioengineering·María Vázquez-Rey, Dietmar A Lang
Apr 14, 2011·MAbs·Josef Vlasak, Roxana Ionescu
Apr 19, 2011·International Journal of Pharmaceutics·Christopher J RobertsErinc Sahin
Jun 15, 2011·Journal of Pharmaceutical Sciences·Rebecca K BrummittChristopher J Roberts
Jul 27, 2011·Journal of Pharmaceutical Sciences·Feng HeVladimir I Razinkov
Nov 16, 2011·Journal of Pharmaceutical Sciences·Andrea HaweWim Jiskoot
Nov 16, 2011·The Journal of Biological Chemistry·Ramil F LatypovDingjiang Liu
Jan 17, 2012·Journal of Pharmaceutical Sciences·Erinc SahinChristopher J Roberts
Feb 4, 2012·Molecular Pharmaceutics·Bruce D MasonBruce A Kerwin
May 2, 2012·International Journal of Pharmaceutics·Wei WangSandeep Nema
May 19, 2012·The Journal of Physical Chemistry. B·Paolo ArosioMassimo Morbidelli
Dec 22, 2012·Molecular Pharmaceutics·Jian Zhang-van EnkJifeng Zhang
Jan 3, 2013·Journal of Pharmaceutical Sciences·Li YiVikas K Sharma
Mar 14, 2013·Analytical Biochemistry·Michael F DrenskiWayne F Reed
Apr 26, 2013·The AAPS Journal·Wei Wang, Christopher J Roberts
Jul 23, 2013·Journal of Pharmaceutical Sciences·Christopher J RobertsNayoung Kim
Jan 11, 2014·Nature Biotechnology·Rob Saurabh Aggarwal
Feb 18, 2014·FEBS Letters·Haixia WuChristopher J Roberts
Aug 15, 2014·The Journal of Physical Chemistry. B·Lucrèce NicoudMassimo Morbidelli
Oct 10, 2014·Nature Biotechnology·Gary Walsh
Apr 18, 2015·The Journal of Physical Chemistry. B·Gregory V BarnettChristopher J Roberts

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Citations

Nov 30, 2016·Journal of Pharmaceutical Sciences·Teddy J ZbacnikMark Cornell Manning
May 20, 2017·The Journal of Physical Chemistry. B·Cesar Calero-RubioChristopher J Roberts
May 3, 2018·Protein Science : a Publication of the Protein Society·Diana GomesChristopher J Roberts
Dec 7, 2019·The Protein Journal·Celimar Sinézia, Luís Maurício T R Lima
Dec 4, 2020·Journal of Pharmaceutical Sciences·Caitlin V WoodChristopher J Roberts
Dec 5, 2020·Scientific Reports·Hongyu Zhang, Paul A Dalby
Jan 14, 2020·Journal of Pharmaceutical Sciences·Caitlin V WoodChristopher J Roberts
Oct 27, 2021·Molecular Pharmaceutics·Diana C GomesChristopher J Roberts

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