“KBI Pharma (KBI) is experiencing strong increases in demand at both our North Carolina and Colorado facilities,” CEO Tim Kelly told BioPharma-Reporter.com.
“Our North Carolina expansion will allow us to respond to the demand for commercial manufacturing for mammalian cell culture products, while our Colorado expansion creates the ability to respond to demand for clinical and commercial manufacturing of low dose microbial products,” he told us.
The contract development and manufacturing organisation (CDMO) will invest approximately $30m (€26.8m) in the project.
The Durham facility houses cGMP cell culture manufacturing lines for clinical production, and offers process development, analytical and formulation services.
The expansion will include 2 x 2000L single-use bioreactors and downstream purification suites to increase commercial mammalian cell culture manufacturing line capability.
“Increasing our manufacturing capacity and adding commercial production capabilities to our Durham site will enable KBI to win more manufacturing contracts, grow our business, and create value for our employees, corporate partners, and clients,” said Kelly.
Currently, KBI’s Boulder site offers commercial manufacturing capacity for microbial processes at 15000L scale.
The Boulder expansion will incorporate a second complete manufacturing train with 300L scale fermentation capability which leverages single-use technologies.
“This additional, smaller-scale capacity will ensure that KBI can continue to meet the process development and clinical manufacturing needs of its clients, as well as commercial manufacturing needs for low-dose microbial products,” said KBI.
The expansion plans will also create jobs in KBI’s operations, and quality groups to realise the potential of the enlarged capacity, said Kelly.
KBI expects to complete the expansions later this year.
KBI recently acquired a cell therapy manufacturing facility in Texas, and plans to open an analytical services laboratory in Belgium next year.