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The spin-off of the university Holostem Terapie Avanzate hosted at C within the Regenerative Medicine "Stefano Ferrari" (CMR) of Unimore feast its ten years and is the occasion to remember the exceptional stages that have seen protagonist, on the international scene, many records, both scientific and industrial. Born to meet the new European regulation 1394/2007 which equated advanced therapies (cell therapy, gene therapy, tissue engineering) with drugs, Holostem Terapie Avanzata relies on the virtuous union between the scientific capabilities of world-renowned researchers, such as Michele De Luca and Graziella Pellegrini, the innovative spirit of the University of Modena and Reggio Emilia (Unimore) and the industrial skills of Chiesi Farmaceutici SpA, essential to continue to bring the products of research into stem cells epithelial to patients. [19659002] "The collaboration between science and industry on the one hand, between the public and the private on the other hand, has always been so close that the results obtained in recent years by the One or the other of Holostem's partners are virtually indistinguishable " Paolo Chiesi, president of Holostem and vice president of Chiesi Farmaceutici
" He soli the scientific experiment, the extraordinary clinical results obtained and the international credibility of Michele De Luca and Graziella Pellegrini, as well as the seriousness of Unimore, convinced us to invest in this avant-garde biotechnological reality which required the industrialization of our pharmaceutical know-how. "Andrea Chiesi, vice-president and founding member of Holostem
Thanks to Holostem's regulatory skills, GMP certification (Good Manufacturing Practice) was obtained in a very short time for the production of cell cultures for cell and gene therapy, initially only for clinical trials (2010) and then for commercial production throughout Europe (2014). Holostem was the first certified product in the world to be certified for the amount of stem cells administered. He obtained the marketing authorization in 2015 under the name of Holoclar and it is used to reconstruct the corneal epithelium damaged by thermal or chemical burns, allowing the full recovery of the ability visual.
"The Industrialization of Crops and l The regulatory procedure required for approval was a real challenge for researchers like us who had never before encountered all the other aspects that besides scientific aspects, are essential to bring the results of many years of research to patients. " Graziella Pellegrini, Holostem R & D Director and RMC Cell Therapy Coordinator
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