Major regulatory milestone demonstrates compliance with stringent standards for cGMP drug substance manufacturing.
GENEVA, December 20, 2022– KBI Biopharma, Inc. (KBI), a JSR Life Sciences company, today announced its recently expanded, state-of-the-art Geneva mammalian cell manufacturing facility has obtained a Swissmedic regulatory establishment license. This important designation demonstrates compliance with current Good Manufacturing Practice (cGMP) standards for the production and release of drug substances for clients.
The license allows KBI to fully support clients in their next phases of growth and certifies KBI's manufacturing capabilities in a cGMP environment.
"It's critical for our drug development clients moving into phase one and phase two clinical trials to confidently partner with trusted cGMP-certified manufacturers for their growth and future success," said Mike Landau, Chief Operating Officer of KBI and Selexis. "This license is a critical component of KBI's streamlined and cost-effective solutions to help worldwide biotechnology companies optimize their processes and advance their innovative therapies."
This milestone comes only five months after a significant facility expansion in July 2022, when KBI and Selexis announced the operation of the fully integrated, 8,733 square-meter site combining the Selexis Cell Line Development services (CLD) and KBI's contract development and manufacturing services. The facility, providing clients with true end-to-end CLD, process/analytical development, and manufacturing, continues to generate jobs in the region.
Building on KBI's strong commitment to quality, the timing of the Swissmedic license approval coincided with the company's Leuven, Belgium facility for analytical services, successfully completing a second inspection that resulted in its cGMP renewal.
About KBI Biopharma, Inc.
KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated, accelerated drug development and biologics manufacturing services and expertise to life science companies. With each of its 500+ client partners, KBI works closely to personalize and rapidly accelerate drug development programs. Built upon a foundation of world-class analytics capabilities and extensive scientific and technical expertise, KBI delivers robust process development and clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs. Recognized for quality manufacturing, KBI helps partners advance drug candidates into the clinic and to the market. KBI serves its global partners with eight locations in Europe and the USA. More information is available at www.kbibiopharma.com.