The biopharmaceutical industry requires rapid, on-site adventitious agent testing to prevent catastrophic contamination events, as current methods take 3–4 weeks to deliver results, leading to wasted production, costly shutdowns, and drug supply disruptions.
Micelle-ELFSE provides a fast, probe-based screening technology that reduces detection time to under one hour, enabling immediate “fail-fast” decisions to minimize financial losses and maintain continuous patient access
By implementing micelle-end-labeled free-solution electrophoresis (micelle-ELFSE) for rapid adventitious agent testing as demonstrated by this project, an organization will reduce contamination detection time from 3–4 weeks to less than 1 hour, enabling immediate “fail-fast” process decisions that prevent wasted production costs and revenue loss.
Constructed a panel of MTE probes by a BLAST search to determine 10-15 nt sequences that appear in viral genomes and not in host Developed a heating/organic modifier protocol that removed secondary structure of ssDNA/ssRNA targets to yield a single peak; stable PNA binding allowed probes to remain bound
Demonstrated an MTE protocol that gives runtime less than 10 mins. with 10-100 pM detection level Developed an isotachophoresis (ITP) + MTE protocol that gives detection of well under 1 fM viral genome in a 20-30 min run
Hui, K., High Resolution Nucleic Acid Electrophoresis by Snagging Mechanisms in Wormlike Micelle Networks, Carnegie Mellon University, Pittsburgh, PA, August 1, 2022. https://www.proquest.com/dissertations-theses/high-resolution-nucleic-acid-electrophoresis/docview/2707589553/se-2
Schneider, J. W. & Przybycien, T. M.. Fail-fast Adventitious Agent Detection in Continuous Cell Culture using Unnatural Nucleic Acid Probes and Ultrabright Fluorophores, Gordon Research Conference: Biotherapeutics and Vaccines Development, Galveston TX, January 6, 2019.
Schneider, J. W., Hui, K., Yan, L., & Przybycien, T. M., Direct, PCR-less Tagging of Viral RNA using Micelle Tagging Electrophoresis (MTE), 93rd ACS Colloid and Surface Science Symposium, Atlanta, GA, June 1, 2019.
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Carnegie Mellon University
Bristol-Myers Squibb
