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Chiara Di Bartolo, MSc
Chiara Di Bartolo, MSc
Qualified Person and Quality Assurance Manager GMP (Cell Factory) / Quality Assurance Manager GCP (Phase I Unit)

Chiara graduated in Biological Sciences (biomolecular specialisation) at the State University of Milan (110 cum laude), with a graduation thesis in the field of molecular immunoregulation performed at DIBIT, San Raffaele hospital. After carrying out research projects in molecular and cellular biology abroad (GSF-Forshchungszentrum fuer Umwelt und Gesundheit GmbH, Munich) and in Italy (Università Statale di Milano and Università di Padova), she was employed at Fidia Advanced Biopolymers (FAB) Srl, Abano Terme, a spin-off of Fidia Farmaceutici focused on research and production of tissue engineering products. For FAB, she carried out research activities within European Community funded projects (at RWTH, Aachen, Germany and UZG University Hospital of Gent, Belgium). Laboratory activities included tissue engineering product development from the selection and testing of hyaluronic acid-based biomaterials to in vitro and in vivo tests for the regeneration of various tissues. In the area of adipose tissue, she performed preclinical product development research up to investigational product production, coordination and monitoring of the first European clinical trial of adipose tissue regeneration, in collaboration with renowned European plastic surgeons pioneering this field. She has also been involved in the coordination of European and company projects on Intervertebral Disk, Nerve, Visceral Tissue, Vessels and Skin regeneration) in the last years at FAB.

On sabbatical, she obtained a Master of Science in Biomedicine, Bioscience and Society at the London School of Economics, London (final mark “A”). The LSE graduation thesis on organ donation in Italy led her to ISMETT in 2006, where she was offered a position as Quality Assurance Manager for the Cell Factory. The same year, she was assigned the role of coordinator of research staff and reference person for various activities between Pittsburgh and Palermo for the newly founded Ri.MED Foundation. In the field of Quality Assurance, she obtained the title of “Evaluator of Quality Management System”(ISO) and the title of “Certified Quality Assurance Manager”, at the Good Manufacturing Practice (GMP) Certification Programme of the European Compliance Academy. She was recognised as Qualified Person for the release of Advanced Therapies by the Italian Medicines Agency in 2011 and obtained the position of Qualified Person for ISMETT Cell Factory. She currently holds a dual contract with ISMETT(Qualified Person) and Ri.MED Foundation (QA Manager), and leads the Production and Quality Control groups (Ri.MED staff) at ISMETT Cell Factory.

In addition to the roles of QA Manager and Qualified Person at ISMETT Cell Factory, thanks to continuous training in GxP, including Good Clinical Practice, she has assumed the role of Quality Assurance Manager for the Phase I Unit, contributing to the certification and maintenance of the Phase I Clinical Unit for the cure of end stage organ failure at ISMETT.

Recent publications

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