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Significance of Cryo-Scanning Electron Microscopy (Cryo-SEM) in Evaluating the Morphology of Multivesicular Liposomes

Published online by Cambridge University Press:  05 August 2019

Soumyarwit Manna ,
Yong Wu ,
Bonhye Koo ,
Xiaoming Xu ,
Stephanie Choi ,
Yan Wang ,
Darby Kozak  and
Jiwen Zheng
Soumyarwit Manna
Affiliation:
Division of Therapeutic Performance, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA. Division of Biology, Chemistry and Materials Science, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.
Yong Wu
Affiliation:
Division of Biology, Chemistry and Materials Science, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.
Bonhye Koo
Affiliation:
Division of Therapeutic Performance, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA. Division of Biology, Chemistry and Materials Science, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.
Xiaoming Xu
Affiliation:
Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Stephanie Choi
Affiliation:
Division of Therapeutic Performance, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Yan Wang
Affiliation:
Division of Therapeutic Performance, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Darby Kozak
Affiliation:
Division of Therapeutic Performance, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Jiwen Zheng*
Affiliation:
Division of Biology, Chemistry and Materials Science, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.
*
*Corresponding author: Jiwen.zheng@fda.hhs.gov

Abstract

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Type
Pharmaceuticals FIG – Imaging, Analysis, and Regulation of Medical Products, Devices and Data Integrity
Information
Microscopy and Microanalysis , Volume 25 , Supplement S2 , August 2019 , pp. 1272 - 1273
Copyright
Copyright © Microscopy Society of America 2019 

References

[1]Manna, S et al. , J. Control. Release 294 (2019), p 279.Google Scholar
[2]Chahar, P and Cumminngs, K III, J. Pain Res 5 (2012), p. 257.Google Scholar
[3]Mantripragada, S, Prog Lipid Res 41(5) (2002), p. 392.Google Scholar
[4]This project was supported in part by an appointment to the Research Participation Program at Center for Drug Evaluation and Research administered by the Oak Ridge Institute for Science and Education through an agreement between the U.S. Department of Energy and FDA. The authors would like to acknowledge FDA Advanced Characterization Facility (ACF), CDRH/OSEL/DBCMS and CDER/OPQ/OTR for instrument use. Soumyarwit Manna, Yong Wu and Bonhye Koo were supported in part by an appointment to the Research Participation Program at the U.S. Food and Drug Administration (FDA), administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the U.S. Department of Energy and the FDA.Google Scholar