Mini factory produces gene therapies at reduced costs

It is like a small miniature pharmaceutical factory, completely robotised. It produces more cell and gene therapies: up to four simultaneously. Potentially cutting up to 70% of current production costs, which today takes place in clean rooms authorised by the national regulatory body (Aifa) with the intervention of a team of at least five professionals. It ranges from the reduction of electrical and maintenance costs to the savings that can be made on personnel expenses. It is called CFBox and is an all-Italian innovation.

It is the world's first customised and automated isolator for the production of gene therapies, the fruit of a partnership between PBL, a hi-tech company from Rubbiano, in the province of Parma, and researchers at the Bambin Gesù paediatric hospital in Rome. With the support - 3.8 million in Pnrr funds - of the National Research Centre 'Development of gene therapy and drugs with RNA technology', financed by the European Next Generation programme and Mur, and involving 32 universities and research centres and 13 affiliated companies (including PBL itself).

If the new machine gets the go-ahead from the regulatory bodies - Ema in Europe, Aifa in Italy - the prototype could be developed on a large industrial scale at national and European level, giving a decisive boost to advanced therapies, which are the new frontier of medicine. Suffice it to say that they currently cost, each, from a few hundred thousand euros to around two million.

"The machine does not reduce production times, which oscillate between 12 and 14 days, but it simplifies and facilitates the process because it better controls the environment, reducing the risk of contamination by the operator," says Concetta Quintarelli, head of the Bambin Gesù tumour gene therapy laboratory. "Moreover, it does not require the intervention of several professionals. We are talking about a versatile tool that allows the production of several different personalised therapies with the first benefit of extreme standardisation, since it is robotised. Today, gene therapies allow us to act in the fight against congenital or acquired diseases, from tumours to autoimmune pathologies. The machine favours their diffusion both in the academic and industrial spheres.

CFBox will be unveiled tomorrow at the headquarters of the Emilia-based company that, founded in 2019 by Franco and Marco Serventi, designs and develops customised pharmaceutical systems for infusion and radioactive drugs. "The machine is ready to be placed on the market," explains Filippo Begarani, head of PBL's R&S and innovation centre. "It took three years of work to develop it. It is equipped with two robots that replicate the same operations that are currently carried out manually by healthcare workers inside clean rooms.