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

• Main Authors: Mariele Viganò (Author), Silvia Budelli (Author), Cristiana Lavazza (Author), Tiziana Montemurro (Author), Elisa Montelatici (Author), Stefania de Cesare (Author), Lorenza Lazzari (Author), Anna Rosa Orlandi (Author), Giovanna Lunghi (Author), Rosaria Giordano (Author)
• Format: Book
• Published: Hindawi Limited, 2018-01-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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 reco...