ArticleACS omega2023
A Liquid Chromatography High-Resolution Tandem Mass Spectrometry Method to Quantify QS-21 Adjuvant and Its Degradation Products in Liposomal Drug Formulations.
Article in ACS omega, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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The trial behind it
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
5 citing papers in PubMed, 9 citations in OpenAlex.
- Could artificial intelligence gradually replace classical adjuvants?Frontiers in immunology · 2026Review
- The challenge of one billion adjuvanted vaccine doses: evaluating scalability, sustainability, and supply capacity of Quillaja saponin QS-21 for large-scale vaccine demand.Frontiers in immunology · 2026Review
- Mechanisms of Self-Assembly of Giant Unilamellar Vesicles in the Army Liposome Formulation (ALF) Family of Vaccine Adjuvants.Pharmaceutics · 2025Article
- Digitally Enabled Generic Analytical Framework Accelerating the Pace of Liquid Chromatography Method Development for Vaccine Adjuvant Formulations.ACS pharmacology & translational science · 2024Article
- Article
Corrections and comments
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Authors and funding
6 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Identification and quantification of an active adjuvant and its degradation product/s in drug formulations are important to ensure drug product safety and efficacy. QS-21 is a potent adjuvant that is currently involved in several clinical vaccine trials and a constituent of licensed vaccines against malaria and shingles. In an aqueous milieu, QS-21 undergoes pH- and temperature-dependent hydrolytic degradation to form a QS-21 HP derivative that may occur during manufacturing and/or long-term storage. Intact QS-21 and deacylated QS-21 HP elicit different immune response profiles; thus, it is imperative to monitor QS-21 degradation in vaccine adjuvant formulation. To date, a suitable quantitative analytical method for QS-21 and its degradation product in drug formulations is not available in the literature. In view of this, a new liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed and qualified to accurately quantify the active adjuvant QS-21 and its degradation product (QS-21 HP) in liposomal drug formulations. The method was qualified according to the FDA Guidance for Industry: Q2(R1). Study results showed that the described method presents good specificity for QS-21 and QS-21 HP detection in a liposomal matrix, good sensitivity characterized by the limit of detection (LOD)/limit of quantitation (LOQ) in the nanomolar range, linear regressions with correlation coefficients,
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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.