Italian Medicines Agency (AIFA) has granted operational authorisation to biotech company ReiThera to open its new production area at its pharmaceutical facility located at the Castel Romano Technopole.
The new 1,500m2 facility will expand the company’s large-scale viral vectors production capabilities for vaccines and gene therapy.
It has been designed to meet the increasing demand for viral vector production across the world.
The facility provides maximum flexibility to accommodate GMP productions based on Adenovirus (Ad), Adeno-associated virus (AAV) and Lentivirus from 50 litres to up to 93,000 litres maximum.
It will serve as the client base for ReiThera that ranges from small biotechnology companies to multinational pharmaceutical companies.
With more than $14.8m (€15m) investment, the company commenced the construction of the new facility in May 2020.
The investment allowed the latest generation bioreactors installation with scaled volume capacities of 200, 1,000 and 2,000 litres.
ReiThera co-founder and chief technology Stefano Colloca said: “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.”
The company is dedicated for GMP manufacturing, technology development, and clinical translation of genetic vaccines and medicinal products for advanced therapies.
It has developed genetic vaccines for major infectious diseases that include Respiratory Syncytial Virus, Covid-19, malaria, hepatitis C, HIV, and Ebola.