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New 1,500 square meter facility granted operational authorization from AIFA, the Italian Medicines Agency, to enable production scales of up to 3,000 liters.
November 8, 2022
By: Tim Wright
Editor-in-Chief, Contract Pharma
ReiThera, a biotech company dedicated to the development of new technologies, GMP production and the clinical translation of genetic vaccines and products for advanced therapies, has received operational authorization from the Italian Medicines Agency (AIFA) to open the new production area at its pharmaceutical facility at the Castel Romano Technopole, for the large-scale production of viral vectors for vaccines and gene therapy. Designed to meet the growing global demand for viral vector production, the new facility offers maximum flexibility in processing scale, able to accommodate GMP productions based on Adenovirus (Ad), Adeno-associated virus (AAV) and Lentivirus starting from 50 liters up to a maximum of 3,000 liters. The facility will serve ReiThera’s client base, which ranges from small biotechnology companies to large multinational pharma groups. To date, ReiThera’s team has successfully developed genetic vaccines against major infectious diseases, including hepatitis C, malaria, HIV, Respiratory Syncytial Virus, Ebola and Covid 19. The construction of the new production facility, which covers an area of 1,500 square meters, began in May 2020 with investment of over €15 million by ReiThera. This investment enabled the installation of the latest generation bioreactors with scaled volume capacities of 200, 1,000 and 2,000 liters. “Thanks to the operational authorization of this expanded facility, the ReiThera team, which combines high-level scientific knowledge with extensive experience in the engineering and bioprocessing of viral vectors, will be able to support companies engaged in the development of products in the field of vaccines and advanced therapies, from the fine-tuning of small-scale production processes to production on a commercial scale,” said Stefano Colloca, chief technology officer and ReiThera co-founder. ReiThera has its headquarters, R&D laboratories and GMP facilities in Rome, Italy.
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