A rapid sterility method using solid phase cytometry for cell-based preparations and culture media and buffers
Abstract
In this article, we demonstrate a rapid sterility testing method for non-filterable cell-based preparations and its in-process control media/buffers. The selected rapid sterility test (RST) in this work is based on the ScanRDI ® system, which detects fluorescently labeled microorganisms with solid-phase cytometry. ScanRDI ® has been chosen due to its sensitivity for detecting viable microorganisms down to one microbial cell with a shorter time to detection compared with the compendial sterility test (CST) method. The RST was validated for a CAR-T cell-therapy product with 4 days of time to detection (TTD) and evaluated for in-process control of media/buffers with real-time detection method success according to USP , Ph. Eur. 5.1.6, and PDA Technical Report No. 33. The validation parameters included limit of detection and equivalence in routine operations, specificity, robustness, ruggedness, and repeatability. For the validation, a combination of pharmacopoeial ATCC strains as well as in-house isolates were used. In addition, the evaluation study of this RST for in-process control of media/buffers was assessed by performing the limit of detection and equivalence with four representative microorganisms. Where applicable, results were statistically evaluated to demonstrate equivalence and no significant difference of the rapid method as compared with the CST method have been detected. All acceptance criteria have been met, and the solid-phase cytometry technology was successful…
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Direct fluorescent staining and membrane filtration approaches, as in ScanRDI, enable near real-time detection by capturing microorganisms on a membrane, staining with nucleic acid-binding fluorophores, and enumerating via laser scanning cytometry, reducing detection time to less than 3 h depending on bioburden levels.
“Alternatively, direct fluorescent staining and membrane filtration approaches, as employed in systems like ScanRDI, enable near real-time detection by capturing microorganisms on a membrane, staining with nucleic acid-binding fluorophores, and enumerating them via laser scanning cytometry, reducing detection time to less than 3 h depending on bioburden levels (Smith et al., 2010; Mohammadi et al.,”
From Isolator-based point-of-care manufacturing: a practical solution for GMP-compliant cell and extracellular vesicles therapy production (2025) · cites this paper as Mohammadi et al., 2023
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Chiu, Y.-S., Wang, K.-L., & Wu, K.-L. (2025) · Frontiers in Bioengineering and Biotechnology · doi:10.3389/fbioe.2025.1644318 · Cited by 17 · see citing works
“…enable near real-time detection by capturing microorganisms on a membrane, staining with nucleic acid-binding fl uorophores, and enumerating them via laser scanning cytometry, reducing detection time to less than 3 h depending on bioburden levels (Smith et al., 2010; Mohammadi et al., 2023).”
- Authors
- Mohammadi, M., Bauer, A., Roesti, D., & Anders, H.-J.
- Affiliations
- Novartis (Switzerland) (CH)
- ETH Zurich (CH)
- Venue
- PDA Journal of Pharmaceutical Science and Technology
- Publisher
- Parenteral Drug Association, Inc.
- Published
- 2023
- Volume
- 77
- Issue
- 6
- Pages
- 498-513
- ISSN
- 1079-7440 (ISSN-L)
- 1948-2124
- OpenAlex
- W4385801888
- Cited by
- 7
- References
- 0
- Citations by year
- 2026: 3 · 2025: 3 · 2024: 1
- FWCI
- 0.89
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- PDA Journal of Pharmaceutical Science and Technology (publishedVersion)
- PubMed (publishedVersion)
- The Novartis Repository (Novartis) (submittedVersion)
- Topics
- Physical Sciences › Chemistry › Analytical Chemistry › Analytical Methods in Pharmaceuticals
- Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Clinical Biochemistry › Bacterial Identification and Susceptibility Testing
- Keywords
- culture media, buffers, in-process control, CAR T-cell therapy, detection limit, method validation
- MeSH terms
- Culture Media, Humans, Infertility, Technology
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