December 1, 2020 -- KBI Biopharma, a biopharmaceutical contract service organization, has established a new commercial manufacturing facility in Research Triangle Park, NC. The $150 million, 140,000-sq-ft facility is expected to be fully operational in early 2022.
The site will support over 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 targets. The current good manufacturing practice (cGMP) biologics manufacturing site will also be used as a commercialization option for KBI's existing and future partners.
The turnkey facility will feature KBI's single-use platform and is designed to accommodate a variety of mammalian-based biologics manufacturing processing. It will also include a ring corridor for suite access and a "science on display" viewing corridor to showcase the facility.
The location will house up to six 2,000-L, single-use bioreactor systems, and associated harvest and purification equipment, which could produce more than 100 commercial batches annually. KBI will also integrate its advanced analytical services for commercial product characterization and release testing capabilities to support commercial launch and routine supply.
The facility will incorporate manufacturing 4.0 principles and integration of advanced technologies. These include data collection systems like batch records, electronic logbooks, paperless materials management, and laboratory information management systems for quality control data management. These tools will allow for real-time processing, product quality monitoring, and future artificial intelligence technology adoption.
The new site is in close proximity to KBI's RTP mammalian drug development labs. The company is also building a 5,600-sq-ft biologic bulk drug substance manufacturing facility in Geneva.