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Mesoblast Receives FDA Approval To Implement A New Potency Assay, T-Cell Proliferation Inhibition Bioassay, For Release And Stability Monitoring Of All New Commercial Product Lots Of Its Mesenchymal Stromal Cell Product Ryoncil

Sep 24, 2026 · 07:06 AM ET· updated 54m ago

The TIBA assay will ensure sufficient sensitivity to detect any shifts in potency of the commercial product that could arise during changes in manufacturing processes or production in new facilities. This assay will be

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Why It Matters

Mesoblast got permission to use a new testing method for its cell medicine Ryoncil. This test helps catch quality problems early during manufacturing or production changes.

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Source: Benzinga · Read the original report at the publisher. Headline and figures shown for context; data may be delayed.

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