BioProcess Online: The path to producing an insulin biosimilar
Why this story matters
In this technical feature, BioProcess Online sits down with rBIO co‑founder Cameron Owen and CSO Dr. Deenadayalan Bakthavatsalam to unpack the real‑world hurdles of turning laboratory success with R‑biolin into metric‑ton commercial output. Their candid discussion gives investors and supply‑chain watchers a rare, inside look at the scale‑up strategy behind one of the few U.S. startups tackling affordable human insulin.
“Our primary focus right now is getting from pilot batches to several metric tons of insulin per year,” Owen tells BioProcess Online, adding that continuous‑fermentation runs have already demonstrated a 50× yield increase.
Key takeaways
Metric‑ton ambition: rBIO’s target capacity is “several metric tons per year,” a scale rarely attempted by early‑stage biosimilar developers.
Continuous‑fermentation edge: Custom bacterial strains and single‑train processing underwrite a projected cost‑of‑goods drop versus legacy recombinant DNA methods.
Regulatory runway: With pre‑clinical bioequivalence data in hand, rBIO confirms IND‑enabling studies are underway ahead of first‑in‑human trials.
