ArticleScientific reports2022
Development of process analytical tools for rapid monitoring of live virus vaccines in manufacturing.
Article in Scientific reports, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
What it found
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
7 citing papers in PubMed.
- Evaluating the utility of a nanoscale flow cytometer for detection of surface proteins on HIV and extracellular vesicles.Virology journal · 2026Article
- Capacitance Technology Enables Automated Feeding, Improved Expansion, and Higher Throughput of CAR-T Cell Stirred-Tank Bioreactor Cultures.Biotechnology journal · 2026Article
- Navigating the Purification Process: Maintaining the Integrity of Replication-Competent Enveloped Viruses.Vaccines · 2025Review
- Flow virometry: recent advancements, best practices, and future frontiers.Journal of virology · 2025Review
- Real-Time VCC Monitoring and Forecasting in HEK-Cell-Based rAAV Vector Production Using Capacitance Spectroscopy.Engineering in life sciences · 2025Article
- Coaxial Dielectric Spectroscopy as an In-Line Process Analytical Technique for Reaction Monitoring.Organic process research & development · 2023Article
- Minimizing batch-to-batch variability of a live virus vaccine by process analytical technologies.Biotechnology progressArticle
Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In the development of end-to-end large-scale live virus vaccine (LVV) manufacturing, process analytical technology (PAT) tools enable timely monitoring of critical process parameters (CPP) and significantly guide process development and characterization. In a commercial setting, these very same tools can enable real time monitoring of CPPs on the shop floor and inform harvest decisions, predict peak potency, and serve as surrogates for release potency assays. Here we introduce the development of four advanced PAT tools for upstream and downstream process monitoring in LVV manufacturing. The first tool explores the application of capacitance probes for real time monitoring of viable cell density in bioreactors. The second tool utilizes high content imaging to determine optimum time of infection in a microcarrier process. The third tool uses flow virometry (or nanoscale flow cytometry) to monitor total virus particle counts across upstream and downstream process steps and establishes a robust correlation to virus potency. The fourth and final tool explores the use of nucleic acid dye staining to discriminate between "good" and "damaged" virus particles and uses this strategy to also monitor virus aggregates generated sometimes during downstream processing. Collectively, these tools provide a comprehensive monitoring toolbox and represent a significantly enhanced control strategy for the manufacturing of LVVs.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.