DNAfree

DNAfree is a term used in biotechnology and related industries to describe products, processes, or organisms that are free of detectable DNA or designed to avoid the introduction of DNA during production or use. The concept is applied in several contexts, including vaccine and therapeutic development, genome editing, and diagnostic reagents, where residual DNA can raise biosafety, regulatory, or privacy concerns.

In genome editing, DNA-free approaches deliver editing components as ribonucleoprotein complexes or as mRNA, avoiding plasmid or viral DNA to reduce the risk of genomic integration and off-target effects. In manufacturing, DNA-free designation may refer to reagents produced with stringent controls to eliminate DNA contamination, or to cell lines and production hosts that have been cured of plasmids.

Verification uses sensitive molecular methods such as quantitative PCR, digital PCR, or sequencing to ensure levels are below specified thresholds. Challenges include achieving complete removal or verification at required limits, added production costs, and the need for robust regulatory guidance. The term is sometimes used by companies marketing DNA-free products or services, though it is not a standardized certification across all industries.