New biologics manufacturing facility
KBI Biopharma is building a new commercial biologics manufacturing facility in the Research Triangle Park (RTP), Durham, in North Carolina, US.
The company is co-investing approximately $150m in the facility with an undisclosed pharmaceutical investor to facilitate the manufacturing of the client’s therapeutic protein programmes. The facility will also serve as a commercialisation option for the existing and potential future clients of the KBI.
Expected to create more than 200 operations and quality assurance technical jobs, the facility is anticipated to be operational in the first quarter of 2022.
The new site is located near KBI’s RTP mammalian drug development laboratories in Patriot Park, a new multi-phase industrial development situated in the Research Triangle area. It is built by Strategic Capital Partners, which is headquartered in Indianapolis.
The site was strategically secured in collaboration with Cushman & Wakefield due to its accessibility to the highly-skilled workforce, combining the region’s talent, technical and academic skills. It is also in proximity to the Raleigh-Durham (RDU) International Airport.
KBI’s new state-of-the-art commercial manufacturing facility will be built upon an area of 140,000ft2 and incorporate Manufacturing 4.0 principles by utilising the latest automation and digitalisation technologies to better address the needs of its clients.
The biologics manufacturing facility will be equipped with up to six 2,000l single-use bioreactors along with the related harvest and purification equipment to manufacture more than 100 commercial batches a year.
It will feature a ring corridor for access to suite and a ‘science on display’ viewing corridor to display the facility to KBI clients.
The digital facility will incorporate data collection tools, such as electronic batch reports, electronic logbooks, paperless materials management and laboratory information management systems (LIMS), to manage the quality control data.
They will allow the monitoring of product quality and processes in real-time, as well as enable to adopt artificial intelligence (AI) technologies in future.
Advanced analytical services will be employed to characterise the commercial product and release testing capabilities to facilitate the commercial launch and routine supply.
Design-build construction will use the proven single-use platform of KBI to make its supply reliable with the dispensable equipment, automation and complete utility back-up.
The design allows flexibility to house diverse manufacturing processes for mammalian-based biologics.
Established in 2013, KBI Biopharma, a subsidiary of JSR Life Sciences, is a biopharmaceutical development and contract manufacturing organisation based in the US.
The company provides fully-integrated, accelerated drug development and bio-manufacturing services for mammalian, microbial and cell therapy programmes to pharmaceutical and biotechnology companies globally.
Its capabilities and services include cell-line development, process, analytical & formulation development, clinical manufacturing, commercial manufacturing, cell therapy, and characterisation & consulting. The company has partnered with more than 300 clients and employs more than 1,000 people globally.
KBI Biopharma has supported the advancement of more than 300 molecules in more than 70 indications.
In October 2020, JSR Life Sciences announced the expansion of its biologics manufacturing facilities in Geneva, Switzerland, for its subsidiaries Selexis And KBI Biopharma. The site is expected to be operational by mid-2022 and will allow KBI to deliver bulk drug production of clinical cGMP biologics to European customers.
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