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Semi-automation of process analytics reduces operator effect.

A Christler1, E Felföldi1, M Mosor1

  • 1Austrian Centre of Industrial Biotechnology, Muthgasse 11, 1190, Vienna, Austria.

Bioprocess and Biosystems Engineering
|December 9, 2019
PubMed
Summary
This summary is machine-generated.

Semi-automating process analytics for impurity quantification in downstream processing significantly reduced workload and operator variability. This enhances analytical robustness for Quality by Design approaches.

Keywords:
ELISAEndotoxinHost cell proteinsLiquid handlingPicoGreenPipettingdsDNA

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Process Analytical Technology (PAT)

Background:

  • Downstream processing in biopharmaceuticals requires robust analytics for impurities like host cell DNA, proteins, and endotoxins.
  • Current analytical methods can be labor-intensive and prone to operator variability.

Purpose of the Study:

  • To semi-automate process analytics for quantifying common downstream impurities using a liquid handling station.
  • To assess the impact of semi-automation on workload, reproducibility, and operator influence.

Main Methods:

  • Implementation of a commercial liquid handling station for semi-automation of analytical procedures.
  • Quantification of host cell DNA (dsDNA), host cell proteins, and endotoxins.
  • Evaluation of workload reduction, relative standard deviation (RSD) across operators and time, and operator-specific influence.

Main Results:

  • Workload for analyzing elution peaks was reduced by at least 2.41 hours per run.
  • Relative standard deviation was reduced by up to half (e.g., dsDNA from 13.7% to 7.1%) across operators over 6 months.
  • Operator-specific influence on test results was reduced, though intra-operator reproducibility did not improve.

Conclusions:

  • Semi-automation of process analytics enhances robustness and reproducibility by minimizing operator-specific variability.
  • This approach is fundamental for establishing Process Analytical Technology (PAT).
  • The findings support the readiness of downstream processing for Quality by Design (QbD) implementation.