About: Tips and Tricks for Validation of Quality Control Analytical Methods in Good Manufacturing Practice Mesenchymal Stromal Cell Production

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About: Tips and Tricks for Validation of Quality Control Analytical Methods in Good Manufacturing Practice Mesenchymal Stromal Cell Production Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : covidontheweb.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Tips and Tricks for Validation of Quality Control Analytical Methods in Good Manufacturing Practice Mesenchymal Stromal Cell Production
Creator	Lunghi, Giovanna Budelli, Silvia Giordano, Rosaria Lavazza, Cristiana Lazzari, Lorenza Montelatici, Elisa Montemurro, Tiziana Viganò, Mariele Orlandi, Anna De Cesare, Stefania
Source	PMC
abstract	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.
has issue date	2018-09-04(xsd:dateTime)
bibo:doi	10.1155/2018/3038565
bibo:pmid	30254681
has license	cc-by
sha1sum (hex)	0b137fde2327ae4665db6aef52d1c98fc4053864
schema:url	https://doi.org/10.1155/2018/3038565
resource representing a document's title	Tips and Tricks for Validation of Quality Control Analytical Methods in Good Manufacturing Practice Mesenchymal Stromal Cell Production
has PubMed Central identifier	PMC6142742
has PubMed identifier	30254681
schema:publication	Stem Cells Int
resource representing a document's body	covid:0b137fde2327ae4665db6aef52d1c98fc4053864#body_text
is schema:about of	named entity 'TIPS' named entity 'immunophenotyping' named entity 'MSC' named entity 'cellular therapy' named entity 'testing' named entity 'CELLULAR THERAPY' named entity 'PRESCRIPTION OF' named entity 'BIOLOGIC' named entity 'BASED' named entity 'CLASSIC' named entity 'DRUGS' named entity 'INDICATIONS' named entity 'POLICIES' named entity 'SHAPED' named entity 'NOVEL' named entity 'CONTEXT' named entity 'GOOD MANUFACTURING PRACTICE' named entity 'MSC' named entity 'VALIDATION STUDIES' named entity 'NEW' named entity 'THERAPY' named entity 'PRESENT' named entity 'THESE' named entity 'DIFFERENTIATE' named entity 'IMMUNOPHENOTYPING' named entity 'CLINICAL' named entity 'REQUIREMENTS' named entity 'FOLLOWED' named entity 'METHODS' named entity 'MEDICINAL PRODUCTS' named entity 'PECULIAR' named entity 'ENDOTOXINS' named entity 'VALIDATION' named entity 'EXPERIMENTAL' named entity 'ADAPT' named entity 'PRODUCTION' named entity 'WORK' named entity 'MESENCHYMAL STROMAL CELL' named entity 'BIOLOGICAL PRODUCTS' named entity 'SYNTHETIC' named entity '2C CELL' named entity 'VIRUSES' named entity 'COMPENDIAL' named entity 'FULFILL' named entity 'GOOD MANUFACTURING PRACTICE' named entity 'VALIDATION' named entity 'ANALYTICAL METHODS' named entity 'PRODUCTION' named entity 'STERILITY TESTING' named entity 'INTRINSIC' named entity 'PAPER' named entity 'ANALYTICAL METHODS' named entity 'OUR' named entity 'GUIDELINES ' named entity 'AVAILABLE' named entity 'RISK' named entity 'EUROPEAN UNION' named entity 'FULLY' named entity 'RESULTS' named entity 'CHARACTERISTICS' named entity 'CLASSIFIED' named entity 'QUALITY CONTROL' named entity 'TRICKS' named entity 'DEVELOPMENT' named entity 'TRADITIONAL' named entity 'CLASSIFICATION' named entity 'MESENCHYMAL STROMAL CELLS' named entity 'USE' named entity 'POSSIBLE' named entity 'APPROACH' named entity 'RULES' named entity 'EXTREMELY'

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