Trending...
- Omnitronics launches Ecosystem Health Dashboard to enable proactive monitoring across dispatch environments
- New Research Identifies "The Great Junk Transfer": 49% of Americans Would Rather Inherit Nothing Than Sort Through a Relative's Belongings
- UK Financial Ltd Verifies Maya Preferred PRA Circulating Supply, Proving Its Eight-Year Promise of Under 1M Tokens After Chainlink Labs Agreement
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.
More on ncarol.com
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.
More on ncarol.com
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.
More on ncarol.com
- Extreme Heat Strains Home Appliances: Appliance EMT Offers "Summer Rescue" Relief
- Independent West Texas Metal Multi-Instrumentalist & Producer. "MAD CHAD™" Russell Surpasses 1.9 Million Project Interactions Via DFGS Productions
- No Download Needed: Goosechase Adds Browser Play to Every Experience
- TOLI North America Introduces Hitoe AdVantage Homogeneous Sheet, Anti-Viral Flooring for High-Traffic Spaces
- HER Patio Productions celebrates one-year Anniversary of "Say Grace"
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.
More on ncarol.com
- Working Musicians Academy Partners with Black Dog Music Partners to Give Musicians Independent, Income-Producing Careers
- New Thriller Transports Readers to Russia's Remote Kamchatka Peninsula
- Omnitronics launches Ecosystem Health Dashboard to enable proactive monitoring across dispatch environments
- New Research Identifies "The Great Junk Transfer": 49% of Americans Would Rather Inherit Nothing Than Sort Through a Relative's Belongings
- Minus K Technology launches it Educational Giveaway for Universities and Colleges in the USA
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
Filed Under: Business
0 Comments
Latest on ncarol.com
- Socialhose Eyes Southeast Asia and Rejects the Copy-Paste Expansion Playbook
- $40 Billion Global Market Value by 2030 Projected in Unmanned Aerial Vehicle or Other Drone Technology Sector, Growing at 9.2% Compound Annual Growth
- Charlotte-based Steady Tax & Bookkeeping launches to support small businesses nationwide
- Recreation Ponds: The Next Big Backyard Pond Trend?
- $620 Million in Recent Government Contract Awards with More Than $1.2 Billion in Annualized Revenue: Circle8 Group (N A S D A Q: CIRC)
- Lewis County Hydrogen Alliance Launches Phase 1 Work to Turn Forest Residuals into Fuel-Grade Hydrogen and Dispatchable Clean Power
- Next Gen Fibre Selects netElastic vBNG and CGNAT to Fuel Rapid Nationwide Expansion and Eliminate Network Bottlenecks
- Boston Industrial Solutions, Inc. Introduces SAP-G70 Primer for bonding silicone to silicone and other materials
- 'Reflections: Enlightening Insights Into the Divine Mystery' — The Latest Book by Philosopher Steven Colborne
- Scott G. Hoy of Hoy Law Earns 11th Consecutive Super Lawyers Selection
- L2 Aviation Selected for U.S. Air Force KC-46 CASPER Multiple Award Contract
- Leeds Billboard Campaign Drives 188% Traffic Uplift as AI Enquiries Rise 266% for Loud! OOH
- Sister Files Lawsuit Against Georgia Funeral Home for Alleged Mishandling of Brother's Remains
- KeysCaribbean Resorts Offer Savings On Summer Vacations Now Through Aug. 31
- Crossroads4Hope Announces The Lipschutz Women's Fund
- Handmade Coverlet Returns Home to Piedmont Crossing
- AI, Drones, Defense & Explosive Growth: Why ZenaTech Is Emerging as One of the Most Compelling Technology Growth Stories (N A S D A Q: ZENA)
- 91 Per Cent of Enterprises Will Increase AI Spending. Most Can't See the Cost — or the Risk!
- VINCE Lifestyle Magazine Announces Virtual "Health, Wealth & Wellness Summit"
- New ProEssentials v11: Native WinUI Charting Library, 100M Points in 15ms, Following Microsoft's Vision for True Native Swap-Chain Rendering