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DURHAM, N.C.--(BUSINESS WIRE)--KBI Biopharma, Inc. (KBI), a JSR Life Sciences company, announced today the establishment of a new commercial manufacturing facility in Research Triangle Park (RTP) in North Carolina. KBI expects the $150 million, 140,000-square-foot facility to be operational by Q1 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."
In addition to providing cGMP biologics manufacturing for its co-investor, KBI will also use the new North Carolina facility as a commercialization option for KBI's existing and future partners. The new turn-key, design-build construction will utilize KBI's proven single-use platform and provide supply reliability with redundant equipment, automation, and full utility backup. The design enables flexibility to accommodate a variety of mammalian-based biologics manufacturing processes. It also includes a ring corridor for suite access and a "science on display" viewing corridor to showcase the facility to KBI partners.
The new RTP location will house up to six 2,000-liter, single-use bioreactor systems and associated harvest and purification equipment, which can produce more than 100 commercial batches annually. In tandem with the manufacturing operations, KBI will employ advanced analytical services for commercial product characterization and release testing capabilities to support commercial launch and routine supply.
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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 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."
The new site is located in close proximity to KBI's RTP mammalian drug development labs in Patriot Park, a new multi-phase industrial park developed by Indianapolis-based Strategic Capital Partners. KBI collaborated closely with Cushman & Wakefield to secure this building near the Raleigh-Durham (RDU) International Airport.
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. That facility is scheduled to be operational by mid-2022 and will create more than 200 positions in development, operations, and quality assurance.
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About KBI Biopharma, Inc.
KBI Biopharma, a JSR Life Sciences company, is an award-winning biopharmaceutical contract services organization providing fully integrated, accelerated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally. With each of our 300+ client partners, we have worked closely to personalize and rapidly accelerate their drug development programs. Built upon a foundation of world-class analytical capabilities, we deliver efficient process development and clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs. We have locations in Durham and Research Triangle Park (NC), Boulder and Louisville (CO), The Woodlands (TX), and Leuven, Belgium. More information is available at www.kbibiopharma.com
"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."
In addition to providing cGMP biologics manufacturing for its co-investor, KBI will also use the new North Carolina facility as a commercialization option for KBI's existing and future partners. The new turn-key, design-build construction will utilize KBI's proven single-use platform and provide supply reliability with redundant equipment, automation, and full utility backup. The design enables flexibility to accommodate a variety of mammalian-based biologics manufacturing processes. It also includes a ring corridor for suite access and a "science on display" viewing corridor to showcase the facility to KBI partners.
The new RTP location will house up to six 2,000-liter, single-use bioreactor systems and associated harvest and purification equipment, which can produce more than 100 commercial batches annually. In tandem with the manufacturing operations, KBI will employ advanced analytical services for commercial product characterization and release testing capabilities to support commercial launch and routine supply.
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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 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."
The new site is located in close proximity to KBI's RTP mammalian drug development labs in Patriot Park, a new multi-phase industrial park developed by Indianapolis-based Strategic Capital Partners. KBI collaborated closely with Cushman & Wakefield to secure this building near the Raleigh-Durham (RDU) International Airport.
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. That facility is scheduled to be operational by mid-2022 and will create more than 200 positions in development, operations, and quality assurance.
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About KBI Biopharma, Inc.
KBI Biopharma, a JSR Life Sciences company, is an award-winning biopharmaceutical contract services organization providing fully integrated, accelerated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally. With each of our 300+ client partners, we have worked closely to personalize and rapidly accelerate their drug development programs. Built upon a foundation of world-class analytical capabilities, we deliver efficient process development and clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs. We have locations in Durham and Research Triangle Park (NC), Boulder and Louisville (CO), The Woodlands (TX), and Leuven, Belgium. More information is available at www.kbibiopharma.com
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