AM23-MN-29-O: Eyedrops of Human Origin (EDHO)- Guidelines for Production, Clinical Use and Regulation (Enduring)

Eyedrops of Human Origin (EDHO) are a form of MPHO (Medical Product of Human Origin) and, as such, should be subject to the same scrutiny and rigidity as other biotherapies which includes blood transfusion and cellular therapies.The ISBT Cellular Therapies Working Party has identified that this area of biotherapy has yet to receive much focus as it straddles the area between ophthalmology units which prescribe them for use and the establishments involved in production, which often include blood banks.A successful workshop was convened in May 2022, which provided a forum for scientists, regulatory authorities, ophthalmologists, and transfusion experts to discuss the production, quality, clinical use, and regulation of these eyedrops of human origin (EDHO). The purpose was to produce expert guidelines and recommendations on these critical issues to ensure quality standardization. The session will focus on the output of this workshop. The two speakers will introduce the biology and properties of eyedrops of human origin. The talks will discuss donor eligibility for both autologous and allogeneic production, the quality control needed to achieve standardization, and a review of the existing data and clinical trials for the efficacy and safety of EDHO. This session will be useful for ophthalmologists to understand the complexities of manufacturing a biotherapy. It will be useful for blood establishments involved in production to understand the quality and regulatory issues and the clinical use of these products. The talk will also review the commercially available preparations.