GMP facilities for manufacturing of advanced therapy medicinal products for clinical trials: an overview for clinical researchers.
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 facility's in-ability to meet the demands. In this chapter we aimed to outline the current issues with regards to the European Union Directives (EUD) and the proposal for Advanced Therapies, which are of importance to cellular and gene therapy facilities in Europe. This chapter is an attempt to elucidate what the minimum requirements for GMP facilities for cell and gene therapy products are and what is considered necessary to comply with the regulations in Europe.
Department of Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden. Evren.Alici@ki.se
Evren
E
Alici
Pontus
P
Blomberg
D035843:Biomedical Research; D017690:Cell Transplantation / Q000331:legislation & jurisprudence*; D002626:Chemistry, Pharmaceutical; D002986:Clinical Trials as Topic; D005060:Europe; D005062:European Union; D015316:Genetic Therapy / Q000331:legislation & jurisprudence*