Along with offering cGMP biologics manufacturing for its co-investor, KBI may also use the brand new facility as a commercialization choice for KBI’s present and future companions. The brand new design-build will use KBI’s single-use platform and supply provide reliability with redundant gear, automation, and full utility backup. The design permits flexibility to accommodate quite a lot of mammalian-based biologics manufacturing processes. It additionally features a ring hall for suite entry and a “science on show” viewing hall.
The brand new RTP location will home as much as six 2,000-liter, single-use bioreactor techniques and related harvest and purification gear, which may produce greater than 100 business batches yearly. In tandem with the manufacturing operations, KBI will make use of superior analytical providers for business product characterization and launch testing capabilities to help business launch and routine provide.
Following the JSR Life Sciences ONEDigital initiative, the brand new facility will incorporate Manufacturing 4.0 rules via the design and integration of superior applied sciences. The digital plant will characteristic information assortment techniques, together with digital batch data, digital logbooks, paperless supplies administration, and Laboratory Data Administration Programs (LIMS) for high quality management information administration. These instruments will allow real-time course of and product high quality monitoring and permit for future AI expertise adoption.