It is available the full manuscript by Mariele Viganò, Rosaria Giordano and Lorenza Lazzari, published in Regenerative Medicine journal, entitled:
Challenges of running a GMP facility for regenerative medicine in a public hospital
Abstract: Advanced therapy medicinal products represent a new generation of medicinal products for regenerative medicine. Since the implementation of the EU regulation for this innovative class of drugs, the academic and hospital institutions have played a central role in their development and manufacture. For these institutions that are not familiar with the industrial context, being in compliance with the pharmaceutical standards is extremely challenging. This report describes how we dealt with some specific issues during our hospital-based GMP experience. Furthermore, we identify as a future perspective the consistent stimulating contribution that a public entity can ensure for advanced therapy medicinal product development and licensing.
Full article here
Reference: Viganò M, Giordano R, Lazzari L. Challenges of running a GMP facility for regenerative medicine in a public hospital. Regen. Med.12(7), 803–813 (2017).