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Bianchi, Italy

Torre M.L.,University of Pavia | Lucarelli E.,Rizzoli Orthopaedic Institute | Guidi S.,CTP Tecnologie di Processo S.p.A. | Ferrari M.,Cell Culture Center | And 4 more authors.
Stem Cells and Development

Mesenchymal stromal cells (MSCs), as advanced therapy products, must satisfy all the requirements for human use of medicinal products, aiming to maintain the quality and safety of the cells. The MSC manufacturing process for clinical use should comply with the principles of Good Manufacturing Practice (GMP). This ensures that cell preparations are produced and controlled, from the collection and manipulation of raw materials, through the processing of intermediate products, to the quality controls, storage, labeling and packaging, and release. The objective of this document is to provide the minimal quality requirements for the MSC production and its delivery for clinical use, so that the safety of the final cell therapy product will not be compromised. For this purpose, the document evaluates the most important steps of GMP-compliant MSC production: the isolation and expansion process; the validation phase of the process, including all quality controls for the characterization, functionality, potency, and safety of MSCs; and the quality control at the batch release to guarantee the safety of patient infusion. © 2015, Mary Ann Liebert, Inc. Source

Renzi S.,Cell Culture Center | Lombardo T.,Cell Culture Center | Dotti S.,Cell Culture Center | Dessi S.S.,Integrated System Engineering | And 2 more authors.
Biopreservation and Biobanking

The advent of stem cells and stem cell-based therapies for specific diseases requires particular knowledge of laboratory procedures, which not only guarantee the continuous production of cells, but also provide them an identity and integrity as close as possible to their origin. Their cryopreservation at temperatures below -80°C and typically below -140°C is of paramount importance. This target can be achieved by incorporating high molar concentrations of cryoprotectant mixtures that preserve cells from deleterious ice crystal formation. Usually, dimethyl sulfoxide (DMSO) and animal proteins are used as protectant reagents, but unexpected changes in stem cell fate and downstream toxicity effects have been reported, limiting their wide use in clinical settings. In scientific reviews, there are not much data regarding viability of mesenchymal stromal cells (MSCs) after the freezing/thawing process. During our routine analysis, a poor resistance to cryopreservation of these cells was observed, as well as their weak ability to replicate. This is an important point in the study of MSCs; moreover, it represents a limit for preservation and long-term storage. For this reason, MSCs isolated from equine, ovine, and rodent bone marrow and equine adipose tissue were compared using different cryopreservation solutions for this study of vitality. Our findings showed the best results regarding cell viability using a solution of fetal bovine serum with addition of 10% DMSO. In particular, we noted an increase in survival of equine bone marrow MSCs. This parameter has been evaluated by Trypan blue staining at fixed times (0, 24, and 48 hours post-thaw). This result highlights the fact that equine bone marrow MSCs are the frailest we analyzed. Therefore, it could be useful to delve further into this topic in order to improve the storage possibility for these cells and their potential use in cell-based therapies. © Copyright 2012, Mary Ann Liebert, Inc. Source

Theodora C.,University of Pavia | Sara P.,University of Pavia | Silvio F.,Innovhub | Alessandra B.,Innovhub | And 9 more authors.
Journal of Applied Polymer Science

In this work platelet lysate (PL) and adipose-derived mesenchymal stromal cells (ASCs) seeded on nonwoven fibroin mats were in vitro and in vivo evaluated for tissue regenerative applications. Nonwoven mats obtained by a large scale water entanglement technique were characterized for their physico-chemical properties. Results indicated a high purity of fibroin fibers, their stability after sterilization process and appropriate technological properties suitable for tissue engineering. Moreover, the scaffolds in vitro supported adhesion and migration of ASCs and the presence of PL improved the cell proliferation. The products were then applied on epithelial/dermal wounds carried out on the dorsal surface of rabbit: the skin reparative process was solved in 9 days, with a completely restitutio ad integrum of the epithelium in animals treated with PL alone; ASCs did not further improve the wound healing. © 2015 Wiley Periodicals, Inc. Source

Lombardo T.,Cell Culture Center | Dotti S.,Cell Culture Center | Villa R.,Cell Culture Center | Cinotti S.,Cell Culture Center | Ferrari M.,Cell Culture Center
Methods in Molecular Biology

Biobanking is an essential tool for ensuring easy availability of high-quality biomaterial collections that combine essential samples and epidemiological, clinical, and research data for the scientific community. Specimen collection is an integral part of clinical research. Indeed, every year throughout the world, millions of biological samples are stored for diagnostics and research, but in many fields the lack of biological material and models is a major hindrance for ongoing research. A biobank facility provides suitable samples for large-scale screening studies and database repositories. Software dedicated to biological banks simplify sample registration and identification, the cataloging of sample properties (type of sample/specimen, associated diseases and/or therapeutic protocols, environmental information, etc.), sample tracking, quality assurance, and specimen availability characterized by well-defined features. Biobank facilities must adopt good laboratory practices (GLPs) and a stringent quality control system and also comply with ethical issues, when required.The creation of a veterinary network can be useful under different aspects: the first one is related to the importance of animal sciences itself to improve research and strategies in the different branches of the veterinary area, and the second aspect is related to the possibility of data management harmonization to improve scientific cooperation. © Springer Science+Business Media New York 2015. Source

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