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

Area of Science:

• Food Science
• Biotechnology
• Cell Biology

Background:

• Cell-based food production necessitates stringent food safety standards for all materials.
• Conventional cell dissociation agents, like animal-derived trypsin, present risks such as viral contamination and allergenicity, limiting their application in food.
• Developing safe, animal-free reagents is crucial for advancing the cell-based food sector.

Purpose of the Study:

• To propose a food regulatory pre-check framework for reagent development.
• To develop and validate a novel, food-grade, animal-free cell dissociation reagent for the cell-based food industry.

Main Methods:

• A regulatory pre-check framework was established to prioritize compliance.
• A new reagent, iDisper, was formulated using approved food additives: papain and trisodium citrate.
• Dissociation efficacy, cell viability, and reagent stability were evaluated using primary avian cells.

Main Results:

• An optimized iDisper formulation (2 mg/mL papain) showed dissociation efficacy and cell viability comparable to commercial agents.
• iDisper demonstrated significant stability, maintaining integrity for 8 months at -20 °C.
• The proposed framework effectively guided the development of a safe and practical reagent.

Conclusions:

• The developed food-grade, animal-free cell dissociation reagent, iDisper, meets safety and efficacy requirements for cell-based food production.
• The food regulatory pre-check framework is a validated strategy for creating safe and compliant reagents.
• iDisper offers a viable alternative to animal-derived agents, supporting the growth of the cell-based food industry.