In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|April 22, 2022
Catalent to Invest $350 Million in Manufacturing Facility in Bloomington, Indiana
Author(s)BioPharm International Editors
Catalent will invest $350 million into integrated biologics drug substance and drug product manufacturing at Bloomington, Indiana facility.
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Catalent announced on April 21, 2022 that it is planning a multi-year $350 million investment at its facility in Bloomington, Ind. to expand its biologics drug substance and drug product manufacturing capabilities.
The project will include the additions of new 2000-liter single-use bioreactors, syringe filling lines, and additional lyophilization capacity supported by quality control laboratories and complex automated packaging. The packaging space will have high-speed, automated cartoning, and auto-injector device assembly capabilities. These new capabilities are expected to be fully operational later in 2022.
The project aims to be completed in 2024 and is expected to add more than 1000 new jobs to Catalent’s Bloomington workforce. The expansion follows a series of recent investments in Catalent Biologics’ global network, including the modernization of its fill/finish and packaging facility in Limoges, France, and the acquisition of a new biologics development and manufacturing facility near Oxford, United Kingdom.
“We continue to see strong growth in demand for biologics development and manufacturing with a deep pipeline across multiple indications,” commented Mike Riley, president of biotherapeutics at Catalent. “These investments will enable us to expand our flagship Bloomington facility and extend our leadership as one of the largest and most comprehensive global centers for integrated manufacturing capabilities. The site offers highly flexible and scalable solutions to companies developing new biological drugs, vaccines, RNA therapies, and other innovative treatments for patients around the world.”
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