🚨Antibiotic-free biologics: regulatory pressure is accelerating.
With the USDA’s CVB Notice 23-06 setting zero tolerance for antimicrobial resistance (AMR) genes in new veterinary biologics, and with FDA, EMA, PMDA, and NMPA already discouraging antibiotics or resistance markers in cell substrates, the shift is clear: antibiotic-based selection systems are becoming a liability. Beyond compliance, the threat of future labeling restrictions or even market withdrawal looms large..
To help industry leaders anticipate this regulatory transformation, Syngulon has prepared an executive white paper on antibiotic-free selection systems for recombinant protein production in E. coli. This overview compares existing antibiotic-free alternatives and highlights Syngulon’s patented bacteriocin-based technology—a plasmid-only, host-independent solution already validated at industrial scale.
Discover how you can reduce compliance risks, improve yields, and secure long-term sustainability with antibiotic-free solutions.