Robust design of adenovirus purification by two-column, simulated moving-bed, size-exclusion chromatography

Journal of Biotechnology
Piergiuseppe NestolaJosé P B Mota

Abstract

A simple, yet efficient, two-column simulated moving-bed (2CSMB) process for purifying adenovirus serotype 5 (Ad5) by size-exclusion chromatography (SEC) is presented and validated experimentally, and a general procedure for its robust design under parameter uncertainty is described. The pilot-scale run yielded a virus recovery of 86 percent and DNA and HCP clearances of 90 and 89 percent, respectively, without any fine tuning of the operating parameters. This performance compares very favorably against that of single-column batch chromatography for the same volume of size-exclusion resin. To improve the robustness of the 2CSMB-SEC process the best set of operating parameters is selected only among candidate solutions that are robust feasible, that is, remain feasible for all parameter perturbations within their uncertainty intervals. This robust approach to optimal design replaces the nominal problem by a worst case problem. Computational tractability is ensured by formulating the robust design problem with only the vertices of the uncertainty region that have the worst effect on the product purity and recovery. The robust design is exemplified on the case where the column volume and interparticle porosity are subject to uncer...Continue Reading

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Citations

Jan 6, 2017·Biotechnology Progress·Niklas AnderssonPeter Tiainen
May 31, 2017·Biotechnology Progress·Michael D HughsonLeda R Castilho
Nov 28, 2019·Expert Opinion on Biological Therapy·Mafalda G MoleirinhoCristina Peixoto
May 28, 2020·International Journal of Molecular Sciences·Ana RicobarazaRuben Hernandez-Alcoceba
Jun 9, 2020·Journal of Chromatography. a·Abimaelle S ChibérioJosé P B Mota
Apr 6, 2021·Biotechnology and Bioengineering·João P MendesManuel J T Carrondo
Apr 30, 2021·Biotechnology and Bioengineering·Sofia B CarvalhoRicardo J S Silva
Nov 2, 2018·Analytical Chemistry·Panagiotis KondylisStephen C Jacobson

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