Swissmedic licenses expanded KBI mammalian cell manufacturing plant

KBI Biopharma says Swissmedic licensure for its expanded mammalian cell manufacturing facility in Geneva will be key to helping customers optimize processes and cut costs.

The contract development and manufacturing organization (CDMO) was licensed in December after the Swiss drug regulator deemed KBI’s mammalian cell manufacturing plant was in compliance with current Good Manufacturing Practice (cGMP) standards.

Chief operating officer Mike Landau said the licensure allows KBI to fully support clients in their next phases of growth and certifies the firm’s manufacturing capabilities in a cGMP environment.

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“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.

“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,” Landau said.

KBI expanded the Geneva facility last July in collaboration with cell line development Selexis, also a JSR Life Sciences company. The idea is to provide cell line development and contract manufacturing services at the same site.

The license approval follows a few months after KBI’s manufacturing facility in Leuven, Belgium passed a cGMP license renewal inspection by Belgian regulatory agency, the Federal Agency for Medicines and Health Products (AFMPS/FAGG).

At the time KBI said, “This cGMP renewal in Leuven enables KBI to continue providing analytical services to help clients develop lasting solutions to the analytical challenges that come with the development of biologics.”

The licensures mark the end of a year that saw KBI CEO Mark Womack step down just six months after being appointed.

In November Tim Lowery, who president of JSR Life Sciences, was appointed as interim CEO to give the CDMO the time to identify a permanent replacement.