Trending...
- Pregis Launches Sharp InfinX: On-Demand Rightsized Mailing System Delivering a Precision-Sized Mailer for Every Order
- Tulsa Air & Space Museum Launches "Give $16 for the F-16" Challenge to Bring Thunderbird Home for Veterans Day
- RAS AP Consulting Issues National Compliance Alert and Launches Q4 2026 AP Readiness Program Ahead of IRS FIRE → IRIS Cutover
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
- Vegan Kingz Expands Direct-Import Wholesale Lineup to Help Commercial Kitchens Cut Ingredient Costs
- Acuvance Survey Finds ERP Integration Remains a Key Challenge as Healthcare Organizations Prepare for AI
- Everything Policy Unveils Their Classroom Resources Behind Every Policy Topic
- Constantine "Costa" Kapothanasis II Acquires The Lubri-Loy Company, Carrying a 77-Year-Old American Lubricant Brand Into Its Next Era
- LS2 Partners with Angels Of Dirt's "Next Chapter Racer" Series Celebrating Women and Girls in Motorsports
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
- Danish company biosuite introduces biotech procurement software to track outsourced R&D commitments
- Industrial & systems engineering educator and professional to lead global strategic partnerships for professional society
- LCM Company Explains Professional Upholstery Cleaning in Charlotte, NC
- Convergence of AI, Wearable Technology, Remote Patient Monitoring and Real-World Healthcare: PomDoctor Ltd. (N A S D A Q: POM)
- Maple Ridge Landscaping Celebrates 50+ Years Serving Boone, NC and the High Country
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
- Hannk And Zubie Join Forces To Shape The Next Generation Of Connected Vehicle Telematics
- Coinfiliate Launches Platform to Helps Shoppers Earn Cashback and Creators Earn Referral Rewards
- Holiday Gambling Spending Expected to Rise 12% in December
- RAS AP Consulting Issues National Compliance Alert and Launches Q4 2026 AP Readiness Program Ahead of IRS FIRE → IRIS Cutover
- Claude Zdanow named Managing Director in Miami, Florida
- Pregis Launches Sharp InfinX: On-Demand Rightsized Mailing System Delivering a Precision-Sized Mailer for Every Order
- netElastic Announces vBNG And CGNAT 2.0 General Availability
- Postmortem Pathology Highlights Private Autopsy Options for Las Vegas Families During Summer Months
- Postmortem Pathology Offers Sacramento Families Independent Answers on a Short Timeline
- AI Is Forcing the Music Industry to Verify Who's Behind the Music. KayeDinero Has Multiple Lanes
- NEW Three Fully Furnished Single-Family Model Homes at Heritage at South Brunswick
- After 35 Years, Christian Radio Host Marina Maria Publishes the Novel She Never Forgot
- Freight Broker 911 CEO and President Milton Collier Is Rebuilding the Path Into Freight Brokerage
- Boston Industrial Solutions Launches New and Improved Siliart Website for Silicone Decorators
- Scoop Social Co. Brings Its Signature Mobile Dessert Experience to Phoenix
- Sky Quarry's Big Turning Point: CEO Marcus Laun Outlines the Next Phase for N A S D A Q: SKYQ
- ALIPAC Releases List of 170+ Illegal Noncitizen Voter Indicators
- Hunter Is Releasing New Music For The Holidays!
- Tixpool.com - Naija Premier Event Reseller
- Work 365 Expands Distributor Integrations with Companial for Microsoft Partners