Rapid Microbiology Screening in Pharmaceutical Workflows

C. Surrette, B. Scherer, A. Corwin, G. Grossmann, A. M. Kaushik, K. Hsieh, P. Zhang, J. C. Liao, P. K. Wong, T. H. Wang, C. M. Puleo

Research output: Contribution to journalArticle

4 Scopus citations

Abstract

Recently advances in miniaturization and automation have been utilized to rapidly decrease the time to result for microbiology testing in the clinic. These advances have been made due to the limitations of conventional culture-based microbiology methods, including agar plate and microbroth dilution, which have long turnaround times and require physicians to treat patients empirically with antibiotics before test results are available. Currently, there exist similar limitations in pharmaceutical sterility and bioburden testing, where the long turnaround times associated with standard microbiology testing drive costly inefficiencies in workflows. These include the time lag associated with sterility screening within drug production lines and the warehousing cost and time delays within supply chains during product testing. Herein, we demonstrate a proof-of-concept combination of a rapid microfluidic assay and an efficient cell filtration process that enables a path toward integrating rapid tests directly into pharmaceutical microbiological screening workflows. We demonstrate separation and detection of Escherichia coli directly captured and analyzed from a mammalian (i.e., CHO) cell culture with a 3.0 h incubation. The demonstration is performed using a membrane filtration module that is compatible with sampling from bioreactors, enabling in-line sampling and process monitoring.

Original languageEnglish (US)
Pages (from-to)387-394
Number of pages8
JournalSLAS Technology
Volume23
Issue number4
DOIs
StatePublished - Aug 1 2018

Keywords

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

ASJC Scopus subject areas

  • Computer Science Applications
  • Medical Laboratory Technology

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  • Cite this

    Surrette, C., Scherer, B., Corwin, A., Grossmann, G., Kaushik, A. M., Hsieh, K., Zhang, P., Liao, J. C., Wong, P. K., Wang, T. H., & Puleo, C. M. (2018). Rapid Microbiology Screening in Pharmaceutical Workflows. SLAS Technology, 23(4), 387-394. https://doi.org/10.1177/2472630318779758