Abstract

To be able to produce advanced therapy medicinal products, compliance with regulatory standards while maintaining flexibility is mandatory. For this purpose, careful planning is vital in the design or upgrade of a facility. Similarly, extensive foresight is elemental to anticipate upcoming needs and requirements. Failing this may lead to the facilitys inability to meet the demands. In this chapter we aim to outline the current issues with regards to the European Union Directives (EUD) on advanced therapies, which impact gene and cell therapy facilities in Europe. This chapter is an attempt to elucidate what the minimum requirements for GMP facilities for gene and cell therapy products are and what is considered necessary to comply with the regulations in Europe.

Keywords: ATMP, gene therapy, cell therapy, GMP, clinical grade, clean rooms, regulations, hematopoietic stem cells, somatic cell therapy, SOPs, BSC, BIOBANKING, cryopreservation area, KAROLINSKA GMP FACILITY, Vecura, HEPA filters (High Efficiency Particle Absorbtion), Wave biorector, Cell-Cube, CliniMACS, Alliance for Harmonization of Cellular Therapy Accreditation, European Group for Blood and Marrow Transplantation, International Society for Cellular Therapy, ISCT and EBMT, Tissue and cells directives