Enhanced Bioprinting of 3D Corneal Stroma Patches with Reliability, Assessing Product Consistency and Quality through Optimized Electron Beam Sterilization

This study optimizes sterilization methods for bioprinted 3D corneal stroma patches made from cornea-derived decellularized extracellular matrix (Co-dECM) hydrogels and human keratocytes. It demonstrates the superiority of electron beam sterilization in preserving the mechanical, biochemical, and immunomodulatory properties of hydrogels, ensuring sterility and consistency, which is essential for advancing clinical applications in corneal tissue engineering.

Abstract

This study focuses on the optimization of sterilization methods for bioprinted three-dimensional (3D) corneal stroma patches prepared using cornea-derived decellularized extracellular matrix (Co-dECM) hydrogels and human keratocytes, with the aim of enhancing clinical applications in corneal tissue engineering. An essential aspect of this study is to refine the sterilization processes, particularly focusing on electron beam (EB) sterilization, to maintain the structural and functional integrity of the Co-dECM hydrogels while ensuring sterility. The study reveals that EB sterilization outperformed traditional methods like ethylene oxide (EtO) gas and autoclaving, which tend to degrade the biochemical properties of hydrogels. By optimizing the EB-sterilization process, the essential mechanical and biochemical characteristics needed for successful 3D bioprinting are retained, reducing batch variability in bioprinted 3D corneal stroma patches. Consistency in production is vital for meeting regulatory standards and ensuring patient safety. Moreover, the study investigates the immunomodulatory properties of sterilized hydrogels, emphasizing their potential to minimize inflammatory responses, which is crucial for maintaining keratocyte phenotype. These findings significantly advance biomedical engineering by providing a sterilization method that preserves material integrity, minimizes immunogenicity, and supports the clinical translation of bioprinted corneal stroma patches, offering a promising alternative to donor transplants and synthetic substitutes.