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iBio Inks First Fill-Finish Services Agreement

To provide cGMP sterile fill-finish for the customer’s investigational therapy for late-stage clinical trial

By: Kristin Brooks

Managing Editor, Contract Pharma

iBio, Inc. has initiated its new cGMP sterile fill-finish services operation with the signing of a supply agreement with a clinical-stage biopharmaceutical company developing gene and cell therapies. 

Earlier in June, iBio introduced its cGMP sterile fill-finish capabilities for pharmaceutical products, including monoclonal antibodies, viral vectors and other biologics at its 135,000 square foot CDMO facility located in Bryan, TX. The company will initially focus on clients with preclinical and clinical stage programs.

Under the supply agreement, iBio will formulate and fill clinical research quantities of one of the customer’s investigational therapies into sterile vials for use in a planned late-stage clinical trial.

“Shortly after our fill-finish services launch at BIO 2019, this first supply agreement with an emerging leader in the gene and cell therapy space was established. While we expect our new fill-finish capabilities will also be attractive to our end-to-end CDMO services clients, this first agreement was secured as a stand-alone project and helps validate our ability to work with a variety of cell-based and other biopharmaceutical products in different formats,” said Robert B. Kay, iBio’s chairman and chief executive officer.

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