contractpharmaOctober 22, 2020
Tag: JSR Life Sciences , cGMP , Manufacturing , facility
JSR Life Sciences, LLC is increasing its European footprint with a newly expanded, state-of-the-art facility that will co-locate primary European operations for its affiliate companies KBI Biopharma and Selexis SA. The two companies will occupy 8,700 square meters in Geneva’s ZIPLO (Industrial Zone Plan-les-Ouates) campus. KBI Biopharma’s expanded facility will enable the company to offer clinical cGMP biologics bulk drug substance manufacturing for European clients. Selexis’ new workspaces will allow the company to meet the increasing demand for its highly specialized mammalian cell line development technologies and services. Together, the companies anticipate creating more than 250 new highly technical jobs in the new facilities.
KBI Biopharma’s new 5,600-square-meter biologic bulk drug substance manufacturing facility is scheduled to be operational by mid-2022 and will create more than 200 technical positions in development, operations, and quality assurance. From this facility, KBI will supply customers with cGMP bulk drug substance to meet their clinical trial requirements. The expanded capabilities include two 2,000L single-use cGMP manufacturing trains with process development and analytical testing labs on site. cGMP quality control testing for release and in-process testing will be performed on-site in the new Geneva facility, while cGMP testing of drug substance and drug product stability will remain at the KBI Biopharma BVBA labs in Leuven, Belgium.
Selexis’ Geneva footprint will increase by 200% and is scheduled to be operational by mid-2021. The new space will include laboratory, office, health/wellness, and employee common spaces. Throughout the expansion, Selexis has invested in a Minergie-certified building (a Swiss building standard aimed at construction with above-average demands on quality, comfort, and energy).
Floorplans support the unique technical needs of Selexis cell line workflows, including department-wide segregation and monitoring systems. In addition to new standard cell line development suites, the new facility will also include two separate cell culture suites to accommodate quarantined client-specific cell lines or client-dedicated cell line spaces.
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