ESEARCH TRIANGLE PARK – KBI Biopharma, a contract drug development and manufacturing company with operations in Durham, will establish a new manufacturing facility near Research Triangle Park that will employ more than 200 people in operations and quality assurance.
KBI will co-invest $150 million in the project with an undisclosed pharmaceutical client to support manufacturing of the client’s therapeutic proteins. The 140,000-square-foot facility should be operational by the first quarter of 2022, according to a company news release.
“Expansion of our U.S.-based cell culture operations is a key investment to support our client’s commercialization strategies,” said KBI President and CEO Dirk Lange. “This state-of-the-art facility will leverage the latest innovation in automation and digitalization to best meet the needs for our clients.”
The expansion is the latest growth spurt for KBI, which originated as a spinout of Atlanta life sciences company Kinetic Biosystems and located in Durham in 2003 with the help of a $1 million startup loan from the North Carolina Biotechnology Center. KBI has since become an affiliate company of JSR Life Sciences, a business unit of Tokyo-based JSR Corp.
The new site is located near KBI’s mammalian drug development labs in Patriot Park, a new multi-phase industrial park near the eastern boundary of Research Triangle Park.
The company chose the site for its access to highly specialized resources.The new site is located near KBI’s mammalian drug development labs in Patriot Park, a new multi-phase industrial park near the eastern boundary of Research Triangle Park.
“The combination of talent, technical and academic training in this region is outstanding, which is critical as we are expanding our impact by serving more clients and patients from this new facility,” Lange said.
In addition to providing cGMP (current Good Manufacturing Practices) biologics manufacturing for its co-investor, KBI will also use the new facility as a commercialization option for existing and future partners.
“By expanding our commercial manufacturing footprint with this facility, we are able to provide our partners with launch material and market supply,” Lange said.
The turn-key, design-build facility will house up to six 2,000-liter, single-use bioreactor systems and related harvest and purification equipment that can produce what the company describes as “more than 100 commercial batches of drug annually.”
A GROWING GLOBAL FOOTPRINT
Over the years KBI has helped advance more than 300 molecules in more than 70 unique indications.
The company provides fully integrated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally for mammalian, microbial and cell therapy programs.
In addition to its North Carolina facilities, KBI has locations in Boulder and Louisville, Colo., The Woodlands, Texas, and Leuven, Belgium. KBI says it employs more than 1,000 people globally, most of whom are based in North Carolina, though the company declines to say exactly how many people work where.
In October KBI’s parent company announced a new facility in Geneva, Switzerland, that will house primary European operations for KBI Biopharma and its sister company, Selexis SA.
The expansion, expected to be operational by mid-20022, will enable KBI to offer clinical cGMP biologics bulk drug substance manufacturing for European clients. It will create more than 200 technical positions in development, operations and quality assurance at KBI.
Selexis will create about 50 new jobs at the Geneva site to meet increasing demand for its specialized mammalian cell line development technologies and services.
Original Source: WRAL TechWire