The facility is helping expand mammalian cell culture operations in the United States.
Durham, NC April 22, 2022–(BUSINESS WIRE)–KBI Biopharma, Inc. (KBI), a JSR Life Sciences company, held a groundbreaking ceremony for its new state-of-the-art commercial manufacturing facility. The 150,000-square-foot, $150 million facility is located in Research Triangle Park (RTP), North Carolina. The site provides access to highly specialized talent as well as unrivaled technical and academic excellence.
Currently, the plant employs more than 200 people in various positions in production, supply chain, engineering, quality control and quality assurance. This figure is expected to rise to 350 by the end of the year as the site is currently working hard to attract and hire high performers. The opening ceremony, which took place on 20 April., brought together the following individuals:
Tim Lowry, President of JSR Life Sciences
Michael Landau, Acting COO of KBI
Jesse King, KBI Senior Vice President and Patriot Park Facility Manager
Laura Rowley, PhD, Vice President, Life Sciences Economic Development, NC Biotech
Jeff Durham, CEO of Durham Chamber
KBI built this facility to support the production of mammalian derived products, starting with several late stage commercial and clinical programs for a confidential client.
“Our new plant keeps KBI at the forefront of the latest innovations in automation and digitization,” said Mr. King. “With our top notch people, systems and processes, we aim to be a true center of excellence and an exceptional place to work. »
In full alignment with the JSR Life Sciences ONEDigital initiative, the new facility will apply manufacturing 4.0 principles through the development and integration of cutting-edge technologies. Innovations include:
digital data collection systems, including electronic lot records, electronic registers, paperless workflow, and laboratory information management systems (LIMS) to manage quality control data. These tools will provide real-time quality control of processes and products, and will also allow the introduction of artificial intelligence technologies in the future.
The installation includes a circular corridor to access the premises and offers a visit called “Science in the Spotlight” to introduce the factory to KBI clients.
KBI will use the facility as an alternative to provide its customers with commercial launch materials and market supplies. KBI’s proven one-time platform ensures supply reliability through redundant hardware and automation, as well as end-to-end utility backup. Features include:
Six 2,000 liter disposable bioreactor systems and associated collection and cleaning equipment can initially produce over 70 batches per year and scale up to meet additional demand.
Enhanced analytical services for commercial product characterization and release testing capabilities will support commercial launch and regular deliveries along with manufacturing operations.
“KBI prides itself on being creative and collaborative with its clients,” said Mr. Landau. “Our customers turn to us not only to develop manufacturing processes suitable for commercial deliveries, but also to benefit from our scientific know-how in the context of complex projects that deviate from the standard planning protocol. It is these types of facilities, added to our strong relationships with our clients, that make this possible. »
This is the second major facility expansion that KBI has announced in the past two years. KBI previously announced a new 5,600 square meter biologicals manufacturing plant in Geneva, Switzerland. The site, due to be operational by the end of the first half of 2022, will employ more than 200 people in a variety of development, operations and quality assurance roles.
About KBI Biopharma, Inc.
KBI Biopharma, a JSR Life Sciences company, is a worldwide contract development and manufacturing organization (ODFC) that provides life sciences companies with its expertise and specialized services in drug development and biological, accelerated and fully integrated manufacturing. KBI works closely with each of its more than 500 client partners to tailor and facilitate drug development programs. Leveraging world-class analytical capabilities combined with deep scientific and technical skills, KBI provides efficient cGMP process development, clinical and commercial manufacturing services in mammalian, microbial, and cell therapy programs. Recognized for manufacturing quality, KBI allows its partners to offer drug candidates in and out of the clinic. KBI serves its global partners through its many offices in Europe and the US. www.kbibiopharma.com.
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KBI Biopharma, Inc.
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