Table of Contents Author Guidelines Submit a Manuscript
Stem Cells International
Volume 2018, Article ID 3038565, 16 pages
https://doi.org/10.1155/2018/3038565
Research Article

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

1Department of Transfusion Medicine & Hematology, Laboratory of Regenerative Medicine-Cell Factory, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy
2Department of Clinical Sciences and Community Health, EPIGET Lab, Università degli Studi di Milano, Milan, Italy
3Clinical Laboratory, Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico, Milan, Italy

Correspondence should be addressed to Mariele Viganò; ti.im.ocinilcilop@onagiv.eleiram

Received 20 April 2018; Accepted 3 July 2018; Published 4 September 2018

Academic Editor: Huseyin Sumer

Copyright © 2018 Mariele Viganò et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.