Journal article
A Comprehensive Evaluation of Nanoparticle Tracking Analysis (NanoSight) for Characterization of Proteinaceous Submicron Particles
Journal of pharmaceutical sciences, Vol.105(11), pp.3366-3375
11/2016
DOI: 10.1016/j.xphs.2016.08.009
PMID: 27663383
Abstract
Nanoparticle tracking analysis (NTA) has attracted great interest for application in the field of submicron particle characterization for biopharmaceuticals. It has the virtue of direct sample visualization and particle-by-particle tracking, but the complexity of method development has limited its routine applicability. We systematically evaluated data collection and processing parameters as well as sample handling methods using shake-stressed protein samples. The camera shutter and gain were identified as the key factors influencing NTA results. We also demonstrated that sample filtration was necessary for NTA analysis if there were high numbers of micron particles, whereas the choice of filter membrane was critical for data quality. Sample dilution into corresponding formulation buffer did not affect particle size distributions in our study. Finally, NTA analysis exhibited excellent repeatability in intraday comparison of multiple measurements on the same sample and interday comparison on different batches of samples. Shaking-induced protein aggregation could also be sensitively monitored by NTA. In conclusion, NTA analysis can be used as a robust stability-indicating method for the characterization of proteinaceous submicron particles and thereby complement other analytical methods, provided that consistent sample handling and parametric settings are established for the specific case study.
Details
- Title: Subtitle
- A Comprehensive Evaluation of Nanoparticle Tracking Analysis (NanoSight) for Characterization of Proteinaceous Submicron Particles
- Creators
- Xinsheng Tian - Novo NordiskM Reza Nejadnik - Centre for Human Drug ResearchDorrit Baunsgaard - Novo NordiskAnette Henriksen - Novo NordiskChristian Rischel - Novo NordiskWim Jiskoot - Leiden University
- Resource Type
- Journal article
- Publication Details
- Journal of pharmaceutical sciences, Vol.105(11), pp.3366-3375
- DOI
- 10.1016/j.xphs.2016.08.009
- PMID
- 27663383
- NLM abbreviation
- J Pharm Sci
- ISSN
- 0022-3549
- eISSN
- 1520-6017
- Language
- English
- Date published
- 11/2016
- Academic Unit
- Roy J. Carver Department of Biomedical Engineering; Pharmaceutical Sciences and Experimental Therapeutics
- Record Identifier
- 9984420841802771
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