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Modification of a commercial cell sorter to support efficient and reliable preparation of ALDH-bright cells for clinical use.

Publication ,  Journal Article
Hickerson, D; Fiordalisi, M; Reese, M; Deibert, E; Balber, AE; Kurtzberg, J; Haley, NR
Published in: Cytotherapy
2007

BACKGROUND: Cell populations manufactured by conventional commercial cell sorters have been safely infused into patients, but reliably sterilizing these instruments remains challenging. We are developing clinical protocols involving use of ALDH bright cells manufactured by cell sorting in patients. However, we encountered problems when we attempted to reliably sterilize the FACSAria cell sorter using standard methods. RESULTS: We have identified and modified potential sources of microbial contamination in several FACSAria systems. We added new filter systems to the sheath and sample air lines, to the wet cart fluid supply, and to the sample line. Sheath was provided from an external sterile, disposable bag through sterile disposable tubing sets. The plenum reservoirs were modified in several ways to allow efficient decontamination of internal surfaces. A new bubble filter assembly was added and one valve was eliminated from the sample pathway to improve flow cell sterilization. A new cleaning and sterilization protocol was developed and validated. All cell products manufactured using the modified instrument and validated cleaning protocol have met lot release criteria for prevention of microbial contamination and safe clinical use. DISCUSSION: The instrument modification and cleaning protocol described enable reliable manufacture of ALDH bright cell populations that are suitable for clinical trials. We have manufactured nineteen consecutive samples that meet all clinical release criteria in an on-going Phase 1 human trial.

Duke Scholars

Published In

Cytotherapy

DOI

ISSN

1465-3249

Publication Date

2007

Volume

9

Issue

6

Start / End Page

562 / 568

Location

England

Related Subject Headings

  • Umbilical Cord
  • Sterilization
  • Immunology
  • Humans
  • Flow Cytometry
  • Filtration
  • Endotoxins
  • Colony-Forming Units Assay
  • Cell Survival
  • Aldehyde Dehydrogenase
 

Citation

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Chicago
ICMJE
MLA
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Hickerson, D., Fiordalisi, M., Reese, M., Deibert, E., Balber, A. E., Kurtzberg, J., & Haley, N. R. (2007). Modification of a commercial cell sorter to support efficient and reliable preparation of ALDH-bright cells for clinical use. Cytotherapy, 9(6), 562–568. https://doi.org/10.1080/14653240701466321
Hickerson, D., M. Fiordalisi, M. Reese, E. Deibert, A. E. Balber, J. Kurtzberg, and N. R. Haley. “Modification of a commercial cell sorter to support efficient and reliable preparation of ALDH-bright cells for clinical use.Cytotherapy 9, no. 6 (2007): 562–68. https://doi.org/10.1080/14653240701466321.
Hickerson D, Fiordalisi M, Reese M, Deibert E, Balber AE, Kurtzberg J, et al. Modification of a commercial cell sorter to support efficient and reliable preparation of ALDH-bright cells for clinical use. Cytotherapy. 2007;9(6):562–8.
Hickerson, D., et al. “Modification of a commercial cell sorter to support efficient and reliable preparation of ALDH-bright cells for clinical use.Cytotherapy, vol. 9, no. 6, 2007, pp. 562–68. Pubmed, doi:10.1080/14653240701466321.
Hickerson D, Fiordalisi M, Reese M, Deibert E, Balber AE, Kurtzberg J, Haley NR. Modification of a commercial cell sorter to support efficient and reliable preparation of ALDH-bright cells for clinical use. Cytotherapy. 2007;9(6):562–568.
Journal cover image

Published In

Cytotherapy

DOI

ISSN

1465-3249

Publication Date

2007

Volume

9

Issue

6

Start / End Page

562 / 568

Location

England

Related Subject Headings

  • Umbilical Cord
  • Sterilization
  • Immunology
  • Humans
  • Flow Cytometry
  • Filtration
  • Endotoxins
  • Colony-Forming Units Assay
  • Cell Survival
  • Aldehyde Dehydrogenase