Background: University Collage London’s Institute of Child Health in collaboration with Great Ormond Street Hospital (UCL GOS ICH) has delivered autologous Retroviral (RV) and more recently Lentiviral (LV) Gene Modified CD34+ cells for over 15 years. During this time clinical practices have developed and changed and trials have become increasingly complex with the additional layer of commercialisation. In the last five years the UCL GOS ICH gene therapy trials programme has rapidly expanded and the amount of advanced therapy investigational medicinal product (ATIMP) delivery has also thus increased. Our team has gained extensive knowledge which we have used this to develop a standard operating procedure (SOP) to standardise the delivery of ATIMPs. During the last 15 years, the team have encountered challenges including changing protocols, collaboration with commercial companies, damaged product bags and multiple good clinical practice audits.
Methods: Our team of three nurses documented every step of the process multiple times, then a different nurse audited and monitored the process multiple times to ensure the SOP reflected current practice.
Results: Various Corrective and Preventative Actions (CAPA) and audit findings have been utilised to facilitate change and used to develop this SOP that will effectively standardise and safely deliver our Gene Therapy autologous Lentiviral Gene Modified CD34+ ATIMPs to the patients.
Conclusions: The authors have developed an SOP that standardises the safe delivery of ATIMPs in the clinical area. It details receipt of ATIMP in the clinical area to the safe administration and subsequent documentation of the administration.