Partner 7:Holostem Terapie Avanzate S.r.l., Modena, Italy

Holostem Terapie Avanzate srl is a spin-off company of the University of Modena and Reggio Emilia with the participation of the Chiesi Group, an Italian-based fast growing bio-pharmaceutical company. Stemming from the expertise and pioneering work on epithelia regeneration, Holostem is hosted within the Centre for Regenerative Medicine (CRM) of the University of Modena, this allowing for great interactions between the research activities and the manufacturing of Advanced Therapy Medicinal Products (ATMPs) in one of the largest GMP-approved facilities for ATMPs in Europe.

Holostem has extensive knowledge in regenerative medicine, with specific and unique expertise in the field of reconstruction of human epithelia via stem cells, both with cell-based products and with gene therapy products. The core competence of the group lies in the translational capability to develop and scale-up the manufacturing process of ATMPs according to GMPs, and in applying new products onto humans in a clinical setting. It is currently developing a series of ATMPs and seeking regulatory approval for the first product (regenerated human corneal surface) with the EMA at European level. 

Role in the project: Holostem will participate in the technology transfer and validation of the manufacturing process of 3D cartilage in its production facility, in compliance with GMPs, and will manufacture grafts for pre-clinical and clinical studies.

The new equipment and process will be transferred to Holostem where test runs for the graft manufacturing will be performed within the frame of the process validation to secure manufacturing capability and reproducibility, according to preset specifications.

Holostem will also be involved in addressing the regulatory requirements for the approval and commercialisation of the new products developed within the project, as well as the financial and marketing strategy of the final application, and means of dissemination.