CRISPR seaweed produces heparin analogs

After 14 months of iteration, our lab has stable red macroalgae lines with targeted glycosylation edits that boost 2-O/6-O sulfation and yield a heparin-like polysaccharide showing sub-micromolar anti-thrombin activity in vitro. For those with experience moving marine biopharmaceuticals toward IND, are you seeing regulators favor closed photobioreactor cultivation over offshore farming for consistent GMP-grade polysaccharides, and how are you handling lot-to-lot sulfation profiling at scale?

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In our IND-enabling run on a red algal sulfated polysaccharide, reviewers favored “closed photobioreactor” once we submitted validated CIP/SIP plus an adventitious-agent risk assessment tied to a barcode-tracked seed train, anchored to FDA’s Botanical Drug Development guidance (https://www.fda.gov/media/93113/download); offshore can still work if you hard-wire traceability and eDNA thresholds — are you versioning lines?

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