ReiThera, based in Rome Italy, received operational authorization from the Italian Medicines Agency (AIFA) to open a 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 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, according to Stefano Colloca, MD, CTO and ReiThera co-founder.
The facility will serve ReiThera’s client base, which ranges from small biotechnology companies to large multinational pharma groups, continued Colloca, adding that to date, ReiThera’s team has 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 1500 m2, began in May 2020 with investment of over 15 million Euros by ReiThera. This investment helped enable 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 Colloca.