Subvisible Particulate Contamination in Cell Therapy Products-Can We Distinguish?

Vollrath, Ilona and Mathaes, Roman and Sediq, Ahmad S. and Jere, Dhananjay and Jörg, Susanne and Huwyler, Jörg and Mahler, Hanns-Christian. (2020) Subvisible Particulate Contamination in Cell Therapy Products-Can We Distinguish? Journal of pharmaceutical sciences, 109 (1). pp. 216-219.

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Official URL: https://edoc.unibas.ch/74164/

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Cell therapy products represent an exciting new class of medicinal products, which must be parenterally administered. Thus, compliance with parenteral preparation guidelines is required. One requirement for parenteral products is the characterization of particle contaminations. As cell-based products are turbid suspensions, containing particles, the cells, characterization and control of foreign particle impurities remain a challenge. Within this study, we evaluated a flow imaging microscopy method for the detection and characterization of subvisible particle contaminations in cell-based products. We found that flow imaging microscopy is a potential method where subvisible particle contaminations can be differentiated from the cells in cell therapy products.
Faculties and Departments:05 Faculty of Science > Departement Pharmazeutische Wissenschaften > Pharmazie > Pharmaceutical Technology (Huwyler)
UniBasel Contributors:Huwyler, Jörg and Vollrath, Ilona
Item Type:Article, refereed
Article Subtype:Research Article
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:06 Dec 2021 12:16
Deposited On:06 Dec 2021 12:16

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