Abstract
The partial least square technique (PLS) was applied to the monoclonal antibody (Mab) CB.Hep-1 immunosorbent manufacturing to determine the influence of cyanate ester concentration, ligand concentration and target ligand density on Mab coupling efficiency, elution capacity, Hepatitis B surface antigen purity and ligand leakage (output variables). Results demonstrated that cyanate ester concentration, ligand concentration and density do not have an influence on output variables in assessed ranges. Conversely, the eluted antigen purity was significantly influenced by cyanate ester concentration and ligand concentration. In conclusion, the PLS application allows for the identification of critical variables and improvement of established chromatographic processes.
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Acknowledgments
Authors kindly thank the Center for Genetic Engineering and Biotechnology for the financial support of this work. The first author gratefully acknowledges Relma Tavares de Oliveira, for the inspiration for writing this paper. The team of authors is grateful to Rebecca Deming Ballentine for her assistance in polishing the manuscript.
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Fernández, E.G., Valdés, R., Montero, J.A. et al. Application of the Partial Least Square Technique to Identify Critical Variables in the Immunosorbent Manufacturing. Chroma 68, 375–380 (2008). https://doi.org/10.1365/s10337-008-0689-0
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DOI: https://doi.org/10.1365/s10337-008-0689-0