Engineering regenerative cell therapy products through biofabrication

Regenerative cell therapies delivered as cell suspensions often face limited survival, retention, and tissue integration. Biofabrication produces structured living products with controlled cellular organization and material environments. Here, we present a product-oriented framework linking fabrication-derived attributes to therapeutic function, delivery compatibility, manufacturing reproducibility, quality control, and safety and regulatory evidence. We distinguish biomaterial-free and biomaterial-based products based on whether exogenous biomaterials are retained as structural or functional components of the administered construct, and examine hybridization as an integration strategy. Comparisons across formats assess whether engineered features provide therapeutic value sufficient to justify added manufacturing and translational burdens. This framework guides product design toward the minimum complexity needed to achieve clinically meaningful function with reproducible manufacture and delivery.