KBI Biopharma, Inc., a JSR Life Sciences company, will establish its new $150 million commercial manufacturing facility in Research Triangle Park, North Carolina.
KBI expects the 140,000-square-foot facility, located in close proximity to KBI’s RTP mammalian drug development labs in Patriot Park, to be operational by the first quarter of 2022. The site will host more than 200 technical positions in operations and quality assurance. KBI is co-investing in the facility with an undisclosed pharmaceutical partner to support manufacturing of their therapeutic protein programs.
“Expansion of our US-based cell culture operations is a key investment to support our clients' 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.”
This is the second major facility expansion announced by KBI. Last month, the Company announced a new 5,600-square-meter biologic bulk drug substance manufacturing facility in Geneva, Switzerland.
“KBI has helped to advance more than 300 molecules in more than 70 unique indications. By expanding our commercial manufacturing footprint with this facility, we are able to provide our partners with launch material and market supply,” continued Mr. Lange. “We chose to build this new facility in the Research Triangle Park because it gives us access to highly-specialized resources. 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.”
Following the JSR Life Sciences ONEDigital initiative, the new facility will incorporate Manufacturing 4.0 principles through the design and integration of advanced technologies. The digital plant will feature data collection systems, including electronic batch records, electronic logbooks, paperless materials management, and Laboratory Information Management Systems (LIMS) for quality control data management. These tools will enable real-time process and product quality monitoring and allow for future AI technology adoption.
KBI Biopharma is an award-winning biopharmaceutical contract services organization providing fully integrated, accelerated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally. Built upon a foundation of world-class analytical capabilities, the company delivers efficient process development and clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs. KBI has locations in Durham and Research Triangle Park (NC), Boulder and Louisville (CO), The Woodlands (TX), and Leuven, Belgium.