Antibiotic-free selection is becoming increasingly important in biologics manufacturing as regulators seek to reduce the use of antimicrobial-resistance markers in production systems. Regulatory pressure is particularly clear in veterinary biologics, while broader guidance from major regulatory authorities increasingly encourages alternatives to antibiotic-based selection.
Why Antibiotic-Free Selection Matters
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.
What the White Paper Covers
Syngulon’s executive white paper reviews antibiotic-free selection approaches for recombinant protein production in E. coli. It compares alternative selection strategies and presents Syngulon’s patented bacteriocin-based technology, a fully plasmid-based approach designed to minimize disruption of existing industrial hosts, vector backbones and validated production processes.
Discover how you can reduce compliance risks, improve yields, and secure long-term sustainability with antibiotic-free solutions.
The white paper covers:
- Regulatory drivers for moving beyond antibiotic-resistance markers.
- Syngulon’s bacteriocin-based selection systems, including peer-selection and immunity-only approaches.
- Comparison with other antibiotic-free technologies and key implementation advantages.
- Performance and industrial validation, including plasmid stability, protein production and scale-up.
- Case studies and licensing opportunities for E. coli production platforms.
Learn more about Syngulon’s antibiotic-free selection technology and its applications in E. coli biomanufacturing.