KBI Biopharma Inc.’s recently expanded 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 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.