A food-grade cell dissociation agent via regulatory pre-check framework.

Abstract

Advancements in cell-based foods require materials that meet the highest food safety standards. Conventional cell dissociation agents, such as animal-derived trypsin, pose significant risks including viral contamination and allergenicity, which hinder their use in food production. To overcome this challenge, we propose a food regulatory pre-check framework, which prioritizes regulatory compliance before functional testing. Following this framework, we developed iDisper, a novel food-grade animal-free cell dissociation reagent composed of approved food additives (papain and trisodium citrate). Specifically, an optimized formulation containing 2 mg/mL papain demonstrated a dissociation efficacy and viability comparable to those of commercial agents in primary avian cells. Furthermore, iDisper demonstrated 8-month stability at -20 °C. This study validated the proposed framework as an effective strategy for developing safe and practical reagents for the cell-based food industry.