Semi-automation of process analytics reduces operator effect

• Published in: Bioprocess and biosystems engineering Vol. 43; no. 5; pp. 753 - 764
• Main Authors: Christler, A., Felföldi, E., Mosor, M., Sauer, D., Walch, N., Dürauer, A., Jungbauer, A.
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01-05-2020; Springer Nature B.V
• Subjects: Animals; Automation; Automation, Laboratory; Biological Products - analysis; Biotechnology; Chemistry; Chemistry and Materials Science; CHO Cells; Cricetulus; DNA - analysis; Drug Contamination - prevention & control; Elution; Endotoxins; Environmental Engineering/Biotechnology; Food Science; Humans; Impurities; Industrial and Production Engineering; Industrial Chemistry/Chemical Engineering; Mathematical analysis; Operators; Reproducibility; Research Paper; Technology assessment; PicoGreen; Host cell proteins; Liquid handling; Endotoxin; Pipetting; dsDNA; ELISA
• ISSN: 1615-7591; 1615-7605
• DOI: 10.1007/s00449-019-02254-y

The aim of this study was to semi-automate process analytics for the quantification of common impurities in downstream processing such as host cell DNA, host cell proteins and endotoxins using a commercial liquid handling station. By semi-automation, the work load to fully analyze the elution peak of a purification run was reduced by at least 2.41 h. The relative standard deviation of results among different operators over a time span of up to 6 months was at the best reduced by half, e.g. from 13.7 to 7.1% in dsDNA analysis. Automation did not improve the reproducibility of results produced by one operator but released time for data evaluation and interpretation or planning of experiments. Overall, semi-automation of process analytics reduced operator-specific influence on test results. Such robust and reproducible analytics is fundamental to establish process analytical technology and get downstream processing ready for Quality by Design approaches.