In addition to providing cGMP biologics manufacturing for its co-investor, KBI will also use the new facility as a commercialization option for KBI’s existing and future partners. The new design-build will use KBI’s 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.
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.
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.