ε-Poly-l-lysine biomanufacturing advances: From biosynthesis to specification-grade products and applications.

ε-Poly-l-lysine (ε-PL) translation is limited by a disconnect between titer optimization and application performance, and specification-driven CQAs—especially chain-length distribution—are critical for reproducible industrial lots.

• Why it matters: The field lacks a framework that links molecular structure and critical quality attributes to industrial production and downstream application needs, slowing progress from manufacturing to performance.
• What they did: The authors propose a spec-driven framework: define a minimal CQA set, map molecular determinants to functional relevance, determine feasibility windows under high-throughput biosynthesis, and integrate strain, process, and recovery engineering to meet specifications.
• The result: They conclude that titer alone is insufficient for broad translation, and that chain-length distribution, impurity profile, and manufacturing consistency guide functional performance, safety boundaries, and lot-to-lot reproducibility.

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