The line is expected to be operational by April 2021 and will add capacity to support the growing pipeline of clinical programs and commercial launches at the site
Catalent is investing $50 million to install an additional high-speed vial filling line at its Bloomington, Indiana, facility.
It will provide capacity to produce up to 80 million vials annually under barrier isolator technology and a peristaltic pump filling mechanism, consistent with current good manufacturing practice (CGMP) regulations.
Catalent projects the Bloomington expansion will take approximately 10 months in total, including construction, procurement, installation, and CGMP qualification of the line.
This marks the third major investment in the last two years at the Bloomington site. By the end of 2021, the site will have high-speed filling capacity across three vial lines, two syringe lines, and a flexible line capable of filling vials, syringes, or cartridges.
The facility has expertise in sterile formulation, with drug substance development and manufacturing and drug product fill-finish capacity, including primary and secondary packaging.
“The industry has seen an increased demand for vial filling of biologic drugs, which has been compounded by the accelerated development of vaccine and therapeutic candidates to address the COVID-19 pandemic,” said Mike Riley, Region President, Biologics, North America. “Catalent’s continued investment in this capacity will allow us to remain flexible and continue to support the growth of our customers’ programs.”