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

This study develops an optimized electron beam (EB) sterilization method for bioprinted corneal stroma patches fabricated using cornea-derived decellularized extracellular matrix (Co-dECM) hydrogels with human keratocytes. The research demonstrates that EB sterilization preserves biochemical integrity (GAGs, collagen) and mechanical functionality, outperforming autoclaving and ethylene oxide methods that degrade matrix components. The team validated the approach through rheological, mechanical, and immunological analyses, confirming that EB-sterilized Co-dECM maintains suitable viscosity, modulus, and keratocyte viability (>90%) across 10 production batches. These constructs exhibit reproducibility, safety, and minimal inflammatory response, meeting regulatory standards for biopharmaceutical manufacturing and paving the way for clinically scalable corneal bioprinting.