Rapid Microbiology Screening in Pharmaceutical Workflows

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

Research output: Contribution to journalArticle

1 Citation (Scopus)

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
Externally publishedYes

Fingerprint

Microbiology
Workflow
Drug products
Screening
Turnaround time
Testing
Pharmaceutical Preparations
Infertility
Sampling
Process monitoring
Miniaturization
Antibiotics
Bioreactors
Preclinical Drug Evaluations
Cell culture
Microfluidics
CHO Cells
Escherichia coli
Supply chains
Dilution

Keywords

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

ASJC Scopus subject areas

  • Computer Science Applications
  • Medical Laboratory Technology

Cite this

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

Rapid Microbiology Screening in Pharmaceutical Workflows. / Surrette, C.; Scherer, B.; Corwin, A.; Grossmann, G.; Kaushik, A. M.; Hsieh, K.; Zhang, P.; Liao, J. C.; Wong, Pak Kin; Wang, T. H.; Puleo, C. M.

In: SLAS Technology, Vol. 23, No. 4, 01.08.2018, p. 387-394.

Research output: Contribution to journalArticle

Surrette, C, Scherer, B, Corwin, A, Grossmann, G, Kaushik, AM, Hsieh, K, Zhang, P, Liao, JC, Wong, PK, Wang, TH & Puleo, CM 2018, 'Rapid Microbiology Screening in Pharmaceutical Workflows', SLAS Technology, vol. 23, no. 4, pp. 387-394. https://doi.org/10.1177/2472630318779758
Surrette C, Scherer B, Corwin A, Grossmann G, Kaushik AM, Hsieh K et al. Rapid Microbiology Screening in Pharmaceutical Workflows. SLAS Technology. 2018 Aug 1;23(4):387-394. https://doi.org/10.1177/2472630318779758
Surrette, C. ; Scherer, B. ; Corwin, A. ; Grossmann, G. ; Kaushik, A. M. ; Hsieh, K. ; Zhang, P. ; Liao, J. C. ; Wong, Pak Kin ; Wang, T. H. ; Puleo, C. M. / Rapid Microbiology Screening in Pharmaceutical Workflows. In: SLAS Technology. 2018 ; Vol. 23, No. 4. pp. 387-394.
@article{83896f18e7b7422b865d47508bc89649,
title = "Rapid Microbiology Screening in Pharmaceutical Workflows",
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.",
keywords = "bacteria, bioburden, cell processing, cell therapy, microfluidic, pathogen, pharmaceutical, rapid microbiology, screening, sterility",
author = "C. Surrette and B. Scherer and A. Corwin and G. Grossmann and Kaushik, {A. M.} and K. Hsieh and P. Zhang and Liao, {J. C.} and Wong, {Pak Kin} and Wang, {T. H.} and Puleo, {C. M.}",
year = "2018",
month = "8",
day = "1",
doi = "10.1177/2472630318779758",
language = "English (US)",
volume = "23",
pages = "387--394",
journal = "SLAS Technology",
issn = "2472-6303",
publisher = "Sage Publications",
number = "4",

}

TY - JOUR

T1 - Rapid Microbiology Screening in Pharmaceutical Workflows

AU - Surrette, C.

AU - Scherer, B.

AU - Corwin, A.

AU - Grossmann, G.

AU - Kaushik, A. M.

AU - Hsieh, K.

AU - Zhang, P.

AU - Liao, J. C.

AU - Wong, Pak Kin

AU - Wang, T. H.

AU - Puleo, C. M.

PY - 2018/8/1

Y1 - 2018/8/1

N2 - 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.

AB - 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.

KW - bacteria

KW - bioburden

KW - cell processing

KW - cell therapy

KW - microfluidic

KW - pathogen

KW - pharmaceutical

KW - rapid microbiology

KW - screening

KW - sterility

UR - http://www.scopus.com/inward/record.url?scp=85050383666&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85050383666&partnerID=8YFLogxK

U2 - 10.1177/2472630318779758

DO - 10.1177/2472630318779758

M3 - Article

C2 - 30027813

AN - SCOPUS:85050383666

VL - 23

SP - 387

EP - 394

JO - SLAS Technology

JF - SLAS Technology

SN - 2472-6303

IS - 4

ER -