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Related Experiment Video

Updated: Feb 7, 2026

Workflow and Tools for Crystallographic Fragment Screening at the Helmholtz-Zentrum Berlin

Workflow and Tools for Crystallographic Fragment Screening at the Helmholtz-Zentrum Berlin

Published on: March 3, 2021

Rapid Microbiology Screening in Pharmaceutical Workflows.

C Surrette¹, B Scherer¹, A Corwin¹

¹1 Electronics Organization, GE Global Research Center, Niskayuna, NY, USA.

SLAS Technology

|July 21, 2018

Summary

This study presents a rapid microfluidic assay combined with cell filtration for pharmaceutical microbiological screening. This approach significantly reduces testing time for sterility and bioburden, improving drug production workflows.

Keywords:

bacteria bioburden cell processing cell therapy microfluidic pathogen pharmaceutical rapid microbiology screening sterility

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Area of Science:

Microbiology
Biotechnology
Pharmaceutical Science

Background:

Conventional microbiology testing methods (e.g., agar plate, microbroth dilution) have long turnaround times.
This delay necessitates empirical antibiotic treatment in clinics and causes inefficiencies in pharmaceutical sterility and bioburden testing.
Current limitations impact drug production timelines and supply chain logistics.

Purpose of the Study:

To develop and demonstrate a proof-of-concept for integrating rapid microbiological tests into pharmaceutical workflows.
To address the limitations of conventional methods in pharmaceutical sterility and bioburden testing.
To enable in-line sampling and process monitoring in bioreactors.

Main Methods:

A combination of a rapid microfluidic assay and an efficient cell filtration process was developed.
Demonstrated separation and detection of Escherichia coli from mammalian (CHO) cell culture.
Utilized a membrane filtration module compatible with bioreactor sampling.

Main Results:

Achieved detection of Escherichia coli with a 3.0-hour incubation time.
Successfully separated and analyzed bacteria directly from a mammalian cell culture.
The developed system allows for in-line sampling and process monitoring.

Conclusions:

The integrated microfluidic assay and filtration system offers a rapid alternative for pharmaceutical microbiological screening.
This approach can significantly reduce time-to-result, improving workflow efficiencies in drug manufacturing.
The technology enables real-time process monitoring and faster decision-making in pharmaceutical quality control.