KBI Biopharma is expanding its biopharmaceutical manufacturing capacity at both its Durham, NC, and Boulder, CO, facilities. It is investing approximately $30 million on the two site expansion projects scheduled for completion later this year.

KBI is building commercial mammalian cell culture manufacturing capability within its Durham facility, which also houses cGMP cell culture manufacturing lines for clinical production. KBI’s development capabilities and track record of success in clinical bulk drug substance manufacturing are the foundation for its expansion into commercial production. Upon completion of the project, the commercial manufacturing line will include 2 X 2000L single-use bioreactors and a full complement of recovery and downstream purification suites which will augment the facility’s already robust process development, analytical and formulation development services.

In Boulder, KBI currently offers commercial manufacturing capacity for microbial processes at 1500L scale, and is now building 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.

This expansion is a continuation of KBI’s ongoing growth following the acquisition of its cell therapy manufacturing facility in the Houston, TX, area this past February. KBI also says it plans to expand in Europe with the opening of an analytical services laboratory in Leuven, Belgium in the first quarter of 2018. This expansion will allow KBI to serve the European market with analytical characterization and cGMP testing services.

“These expansions support our vision for growth and create the opportunity to better serve our customers in all areas of the biopharmaceutical industry,” said Tim Kelly, president, KBI. “We are increasing our capacity for existing offerings and expanding into emerging technologies which will enable KBI to serve as a true partner and trusted advisor to our clients as our industry continues to grow.”