Corneal endothelial cell culture in a non-conventional facility for the treatment of corneal endothelial cell deficiency

Abstract

Purpose : To manufacture corneal endothelial cell cultures for the treatment of corneal endothelial dysfunction in an innovative low-cost facility

Methods : A low scale clean room environment was obtained using a positive pressure system. The positive pressure system is equipped with a small portable CO₂ incubator, a phase contrast microscope, and a compact centrifuge.
The particular and specific requirements for manufacturing human corneal endothelial cells in the positive pressure system were established. To this end, the Standard Operating Procedure (SOP) and the Manufacturing Guide were prepared, in accordance with the Good Manufacturing Practice (GMP).
A first batch was produced according to the developed Manufacturing Guide. Subsequently, three batches were produced under the same conditions as specified in the SOP to manufacture corneal endothelial cells and in the Manufacturing Guide

Results : The first batch performed showed that the process was feasible and that only the amount of consumables needed to be adjusted. The next three batches complied with the established process and product control parameters.
Human corneal endothelial cells were efficiently cultured from discarded endothelial tissue for transplantation within the facility. The cells were viable and maintained the native characteristics of corneal endothelial cells

Conclusions : It is possible to manufacture corneal endothelial cell cultures for the treatment of corneal endothelial dysfunction in a non-conventional facility. This manufacturing model reduces the final cost of the product while maintaining the required quality standards

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.