CDMO Services

Quality & Regulatory

Quality & Regulatory Expertise

We understand that you may need guidance to understand what the FDA, EMA and other regulatory bodies require in order to move a product through its regulatory journey. iBio and its preferred regulatory services partner provide support through the entire drug development cycle, including e-publishing of FDA filings.

Established Regulatory Pathways

Not only does plant-based protein expression solve many protein production challenges, the approach is also well-recognized by the FDA, EMA, and other global regulatory bodies.

In fact, in July 2016, the FDA granted orphan drug designation to iBio's investigational biotherapeutic product iBio-CFB03, for the treatment of systemic sclerosis.

Other therapeutics produced by plant-based protein production methods treat a range of conditions including Gaucher disease, Ebola infection, influenza, canine gingivitis, Non-Hodgkin's Lymphoma, and numerous others.