KBI quietly drops mammalian manufacturing in Switzerland

For KBI Biopharma, 2022 was a transitionary year. Along with changes in management, the contract development and manufacturing organization (CDMO) saw its Leuven, Belgium analytical services facility pass a cGMP license renewal inspection, and its Geneva, Switzerland facility attain licensure from regulatory body Swissmedic.

The Geneva site also saw the completion of an expansion project that added laboratory space to support KBI’s now fully integrated sister firm Selexis’s cell line development services, along with a suite of analytical testing laboratories, and cGMP single-use manufacturing trains.

However, two years on and KBI has confirmed to BioProcess Insider that drug substance manufacturing will no longer be offered from Geneva, with the firm opting to centralize such services at a single-use site in Durham, North Carolina.

The decision to establish North Carolina as KBI’s “Center of Excellence for clinical and commercial manufacturing of mammalian drug substance” was made “to improve overall operating efficiency and offset the lack of capacity demand in Geneva for mammalian manufacturing services,” we were told.

The Patriot Park facility in Durham offers scale of up to 2,000 L, through three Xcellerex (from Cytiva) single-use bioreactor systems, and three dedicated purification suites. Recent investments have added an in-house media and buffer preparation facility, water-for-injection (WFI) generation, expanded clean unclassified areas, material storage, and additional warehouse capacity. The nearby Hamlin Road facility also offers clinical and commercial production.

While the focus on North Carolina impacts clinical and commercial manufacturing in Geneva, the firm told us, “KBI and Selexis SA will continue to operate cell line development, process development, analytical development, and analytical testing activities in Geneva, and will continue the use of Geneva as a global office for European operations.”

JSR Life Sciences acquired both cell line development firm Selexis and CDMO KBI in 2017, and while the two divisions have worked in unison for client projects, the two entities were only officially brought together last year by the newly installed CEO JD Mowery.

“The motivation behind the operational consolidation of Selexis into KBI was to streamline the offering for our customers,” he told us at the BIO conference in San Diego in June.