Subvisible Particulate Contamination in Cell Therapy Products-Can We Distinguish?
- Vollrath I Drug Product Services, Lonza AG, Hochbergerstrasse 60A, 4057 Basel, Switzerland; Division of Pharmaceutical Technology, Department of Pharmaceutical Sciences, University of Basel, Klingelbergstrasse 50, 4056 Basel, Switzerland.
- Mathaes R Drug Product Services, Lonza AG, Hochbergerstrasse 60A, 4057 Basel, Switzerland.
- Sediq AS Drug Product Services, Lonza AG, Hochbergerstrasse 60A, 4057 Basel, Switzerland.
- Jere D Drug Product Services, Lonza AG, Hochbergerstrasse 60A, 4057 Basel, Switzerland.
- Jörg S Drug Product Services, Lonza AG, Hochbergerstrasse 60A, 4057 Basel, Switzerland.
- Huwyler J Division of Pharmaceutical Technology, Department of Pharmaceutical Sciences, University of Basel, Klingelbergstrasse 50, 4056 Basel, Switzerland.
- Mahler HC Drug Product Services, Lonza AG, Hochbergerstrasse 60A, 4057 Basel, Switzerland. Electronic address: hanns-christian.mahler@lonza.com.
- 2019-09-16
Published in:
- Journal of pharmaceutical sciences. - 2020
English
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.
- Language
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- English
- Open access status
- bronze
- Identifiers
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- DOI 10.1016/j.xphs.2019.09.002
- PMID 31521641
- Persistent URL
- https://sonar.ch/global/documents/232505
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