iBio (NYSE AMERICAN:IBIO) introduced new cGMP sterile fill-finish capabilities for pharmaceutical products, including monoclonal antibodies, viral vectors, and other biologics.
Designed for clients with preclinical and clinical stage programs, the operation is housed at the company’s 135,000-square-foot contract development and manufacturing organization (CDMO) facility in Bryan, Tex.
“Providing fill-finish services is a natural extension of iBio’s FastPharming biologics CDMO capabilities,” Robert Kay, CEO, said in a statement. “Given our ability to quickly deliver GMP and research quantities of active pharmaceutical ingredient, the addition of the fill-finish operation completes our rapid, end-to-end service offering.”
The sterile liquid fill-finish operation will incorporate in-line labeling, allowing serialization of vials as they are filled. Initial capacity supports 100-to-2,500 vials runs, with plans to expand to 15,000.
“We understand the needs of early-stage companies, who often face moving targets for their timelines and support requirements,” said Nicolas Taquet, VP of biopharmaceutical manufacturing. “It is often problematic trying to identify available capacity for high-quality, small volume filling. We’re now in position to fill that need for our clients.”
