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Tips and Tricks for Validation of Quality Control Analytical Methods in Good Manufacturing Practice Mesenchymal Stromal Cell Production
المؤلفون المشاركون
Viganò, Mariele
Budelli, Silvia
Lavazza, Cristiana
Montemurro, Tiziana
Montelatici, Elisa
de Cesare, Stefania
Lazzari, Lorenza
Orlandi, Anna Rosa
Lunghi, Giovanna
Giordano, Rosaria
المصدر
العدد
المجلد 2018، العدد 2018 (31 ديسمبر/كانون الأول 2018)، ص ص. 1-16، 16ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2018-09-04
دولة النشر
مصر
عدد الصفحات
16
الملخص 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.
نمط استشهاد جمعية علماء النفس الأمريكية (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
نمط استشهاد الجمعية الأمريكية للغات الحديثة (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
نمط استشهاد الجمعية الطبية الأمريكية (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
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-1213312
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
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