FaBioCell Cell factory

FaBioCell is a “cell factory”, namely a pharmaceutical factory authorized to produce drugs for cell therapies. Cell therapies, together with gene therapy drugs and tissue engineering products, constitute the family of Advanced Therapy Medicinal Products or ATMP.

FaBioCell was founded with the aim of encouraging the process of transferring to the clinic the results of research conducted in the field of tumor immunotherapy, not only in ISS but also in collaboration with other research and clinical centers, taking into account the growing attention to the promising clinical use of personalized cellular drugs.

According to the Directive 2001/20/EC (implemented with Legislative Decree n° 211 of 2003, which came into force on 01/01/2004), Drugs for Advanced Therapies must be produced in compliance with the Good Standards Manufacture, GMP, in facilities equivalent to “pharmaceutical workshops” subject to the authorization procedure by the Italian Medicines Agency.
In 2011, FaBioCell obtained the authorization to produce cell therapy drugs (n° aM 30/2011), that was reconfirmed in 2014 (n° aM 139/2014).

To be revised.
(remove this paragraph once finished)