We develop advanced cell therapies for conditions that are difficult to treat today

A GMP (Good Manufacturing Practice) production and biobank cryopreservation project for CAR-T cells consists of collecting the patient's (or a donor's) T lymphocytes, genetically modifying them in a certified GMP environment to express a Chimeric Antigen Receptor (CAR), controlled cell expansion, and subsequent long-term storage through cryogenic freezing (generally in liquid nitrogen at −196 °C).

The availability of a CAR-T biobank makes it possible to build up a stock of already-qualified, ready-to-use cell products, significantly reducing the time between clinical indication and treatment.

From the patient's perspective, this allows faster access to therapy, which is particularly important in aggressive haematological malignancies, where a delay of just a few weeks can compromise therapeutic efficacy.

Furthermore, the availability of cryopreserved aliquots enables potential re-infusions without having to repeat the entire production process. From an economic standpoint, centralised cryopreservation favours larger-batch production, reduces the logistical and staffing costs associated with urgent “just-in-time” production, and lowers the risk of production failures that would require a new cell collection.

GMP standardisation also improves the quality and reproducibility of the product, reducing costs linked to non-conformities, production waste and clinical complications. Looking ahead, the integration of GMP production and biobanking can support the transition from a fully autologous model to “off-the-shelf” platforms based on allogeneic cells, further reducing the cost per treatment and increasing the accessibility of advanced cell therapies.

A GMP production (Good Manufacturing Practice) and biobank cryopreservation project for induced pluripotent stem cells (iPSCs) consists of generating iPSC lines from human somatic cells (e.g. peripheral blood or fibroblasts), reprogramming and characterising them according to rigorous GMP quality standards, and subsequently cryopreserving them in a certified biobank for future use in therapeutic, research and personalised medicine applications.

The availability of an iPSC biobank makes it possible to build a reserve of highly characterised, genetically stable cell lines that are immediately available for the production of specialised cells, such as neurons, cardiomyocytes, hepatocytes or immune cells.

This approach makes it possible to significantly reduce the time needed to obtain a therapeutic cell product, avoiding the need to repeat the entire reprogramming and validation process for each individual patient. From a clinical standpoint, the availability of already-qualified iPSC lines improves patient safety through thorough checks on cell identity, sterility, genomic stability and differentiation potential.

Furthermore, the ability to generate iPSC banks compatible with specific HLA haplotypes makes it possible to develop allogeneic cell therapies with a lower risk of immunological rejection and greater accessibility for broad segments of the population. From an economic standpoint, centralised production and biobanking of iPSCs allow development, quality control and validation costs to be spread across a large number of future treatments.

The availability of already-certified master and working cell banks reduces the production cost per individual therapy, improves industrial scalability and limits the risk of production failures. Looking ahead, such infrastructure represents a key element for the spread of regenerative medicine and future cell therapies based on “off-the-shelf” products, making advanced treatments more accessible, sustainable and timely for patients.