Assessment of Tunable Resistive Pulse Sensing (TRPS) Technology for Particle Size Distribution in Vaccine Formulations - A Comparative Study with Dynamic Light Scattering.

Autor: Misra R; Vaccine CMC Development and Supply, Analytical Sciences, Sanofi, Toronto, Ontario, M2R 3T4, Canada. rahul.misra@sanofi.com., Fung G; Vaccine CMC Development and Supply, Analytical Sciences, Sanofi, Toronto, Ontario, M2R 3T4, Canada., Sharma S; Vaccine CMC Development and Supply, Analytical Sciences, Sanofi, Toronto, Ontario, M2R 3T4, Canada., Hu J; Vaccine CMC Development and Supply, Analytical Sciences, Sanofi, Toronto, Ontario, M2R 3T4, Canada., Kirkitadze M; Vaccine CMC Development and Supply, Analytical Sciences, Sanofi, Toronto, Ontario, M2R 3T4, Canada.
Jazyk: angličtina
Zdroj: Pharmaceutical research [Pharm Res] 2024 May; Vol. 41 (5), pp. 1021-1029. Date of Electronic Publication: 2024 Apr 22.
DOI: 10.1007/s11095-024-03698-y
Abstrakt: Purpose: A comparative assessment was performed to evaluate the potential of particle sizing by an ensemble based conventional dynamic light scattering (DLS) technique and an emerging technology based on tunable resistive pulse sensing (TRPS) using particle by particle approach by evaluating three different types of vaccine formulations representing three case studies and showing the limitation of each technique, instrument variability, sensitivity, and the resolution in mixed population.
Methods: Three types of in-house vaccine formulations- a protein antigen, an outer membrane vesicle and viral particles were simultaneously evaluated by TRPS based Exoid and two DLS instruments-Zetatrac and Zetasizer for particle size distribution, aggregates, and resolution of polydisperse species.
Results: The data from first case study show the risk of possible size overestimation and size averaging in polydisperse samples in DLS measurements which can be addressed by the TRPS analysis. It also shows how TRPS may be utilized only to large size antigens due to its limited size range. The second case study highlights the difference in the sensitivities of two DLS instruments working on the same principle. The third case study show that how TRPS can better resolve the large aggregate species compare to DLS in polydisperse samples.
Conclusion: This analysis shows that TRPS can be used as an orthogonal technique in addition to conventional DLS based methods for more precise and in-depth characterization. Both techniques are efficient in size characterization and produce comparable results, however the choice will depend on the type of formulation and size range to be evaluated.
(© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
Databáze: MEDLINE
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