Establishing food-safe cell lines and banks for cultivated meat: current status and future directions.

Cultivated meat has emerged as a promising complement to conventional livestock production, with the potential to contribute to food security, animal welfare, and more sustainable food systems. As the field advances toward commercial-scale manufacturing, ensuring product safety and consistency depends fundamentally on establishing well-characterized, stable, and food-safe cell lines and cell banking systems. Cell lines underpin cultivated meat production and serve as critical control points for hazards, including microbial contamination, adventitious agents, genomic instability, cell misidentification, and tumorigenic transformation. This review examines current scientific knowledge, regulatory developments, and industry practices related to cell line development and cell banking for cultivated meat production. Drawing on publicly available regulatory dossiers from GOOD Meat, UPSIDE Foods, and Vow Group, it systematically compares approaches to donor animal qualification, cell sourcing, adventitious agent testing, genomic stability assessment, tumorigenicity evaluation, and cell bank monitoring. The analysis reveals substantial variability in testing strategies, documentation practices, and safety assessment criteria, highlighting the absence of internationally harmonized food-grade standards for cell line qualification and banking. By integrating evidence from regulatory dossiers, scientific literature, and established biopharmaceutical guidance frameworks, this review identifies microbial contamination, adventitious agents, genomic instability, and tumorigenicity as priority hazards requiring systematic control. To address these challenges, a risk-based Food-Safe Cell Line and Banking Framework (FSCLBF) is proposed to support future standardization efforts. The development of transparent, affordable, and robust approaches for cell line qualification and banking will be essential for strengthening regulatory confidence, enhancing consumer trust, and supporting commercialization.