After signing a supply agreement with an undisclosed customer, iBio has activated its new current good manufacturing practice (cGMP) sterile fill-finish services operation at its 135,000-square-foot Bryan, Texas facility.
Earlier this month, the plant-based contract development and manufacturing organization (CDMO) introduced its cGMP sterile fill-finish capabilities for products, including monoclonal antibodies (mAbs), viral vectors, and biologics.
Per a recent supply agreement iBio entered, the company has activated its fill-finish capabilities and will formulate and fill clinical research quantities of the customer’s investigational therapies into sterile vials for use in a late-stage clinical trial.
A spokesperson for iBio told us that investigational therapies often have smaller fill requirements, because of the nature of the smaller disease populations.
“Increasingly there is an unmet need for high quality sterile fill-finish services in this space, and iBio’s comfort with a variety of pharmaceutical products, including gene and cell therapy, viral vectors, and mAbs makes it a natural fit for these solutions,” the spokesperson added.
iBio will focus on using the fill-finish capabilities on clients with preclinical and clinical stage programs.
The spokesperson explained that the company’s fill-finish capabilities are specifically targeted at companies with smaller fill requirements, as it is often problematic to identify available capacity for small volume filling with larger CDMOs set up to fill larger and ongoing orders.
