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CDMO iBio introduced cGMP sterile fill/finish services at its facility in Texas.
Contract development and manufacturing organization (CDMO) iBio introduced cGMP sterile fill/finish capabilities for pharmaceutical products, including monoclonal antibodies, viral vectors, and other biologics, the company announced in a June 3, 2019 press release. Designed for clients with preclinical and clinical stage programs, the operation is housed in the company’s 135,000-ft2 facility located in Bryan, TX.
“Providing fill/finish services is a natural extension of iBio’s FastPharming biologics CDMO capabilities,” said Robert Kay, CEO, in the press release. “Given our ability to quickly deliver GMP and research quantities of API, 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 100–2500-vial 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,” commented Nicolas Taquet, vice-president, Biopharmaceutical Manufacturing, in the press release. “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.”