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Tips and Tricks for Validation of Quality Control Analytical Methods in Good Manufacturing Practice Mesenchymal Stromal Cell Production
Joint Authors
Viganò, Mariele
Budelli, Silvia
Lavazza, Cristiana
Montemurro, Tiziana
Montelatici, Elisa
de Cesare, Stefania
Lazzari, Lorenza
Orlandi, Anna Rosa
Lunghi, Giovanna
Giordano, Rosaria
Source
Issue
Vol. 2018, Issue 2018 (31 Dec. 2018), pp.1-16, 16 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2018-09-04
Country of Publication
Egypt
No. of Pages
16
Abstract EN
Mesenchymal stromal cells (MSC) for cellular therapy in European Union are classified as advanced therapy medicinal products (ATMPs), and their production must fulfill the requirements of Good Manufacturing Practice (GMP) rules.
Despite their classification as medicinal products is already well recognized, there is still a lack of information and indications to validate methods and to adapt the noncompendial and compendial methods to these peculiar biological products with intrinsic characteristics that differentiate them from classic synthetic or biologic drugs.
In the present paper, we present the results of the validation studies performed in the context of MSC development as ATMPs for clinical experimental use.
Specifically, we describe the validation policies followed for sterility testing, endotoxins, adventitious viruses, cell count, and immunophenotyping.
Our work demonstrates that it is possible to fully validate analytical methods also for ATMPs and that a risk-based approach can fill the gap between the prescription of the available guidelines shaped on traditional medicinal products and the peculiar characteristics of these novel and extremely promising new drugs.
American Psychological Association (APA)
Viganò, Mariele& Budelli, Silvia& Lavazza, Cristiana& Montemurro, Tiziana& Montelatici, Elisa& de Cesare, Stefania…[et al.]. 2018. Tips and Tricks for Validation of Quality Control Analytical Methods in Good Manufacturing Practice Mesenchymal Stromal Cell Production. Stem Cells International،Vol. 2018, no. 2018, pp.1-16.
https://search.emarefa.net/detail/BIM-1213312
Modern Language Association (MLA)
Viganò, Mariele…[et al.]. Tips and Tricks for Validation of Quality Control Analytical Methods in Good Manufacturing Practice Mesenchymal Stromal Cell Production. Stem Cells International No. 2018 (2018), pp.1-16.
https://search.emarefa.net/detail/BIM-1213312
American Medical Association (AMA)
Viganò, Mariele& Budelli, Silvia& Lavazza, Cristiana& Montemurro, Tiziana& Montelatici, Elisa& de Cesare, Stefania…[et al.]. Tips and Tricks for Validation of Quality Control Analytical Methods in Good Manufacturing Practice Mesenchymal Stromal Cell Production. Stem Cells International. 2018. Vol. 2018, no. 2018, pp.1-16.
https://search.emarefa.net/detail/BIM-1213312
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1213312