KBI Biopharma, Inc. Releases Inaugural FIH Manufacturing Batch at Integrated Switzerland Facility Five Months After Opening
GENEVA- KBI Biopharma, Inc. (KBI), a JSR Life Sciences company, today announced that late in 2022, it successfully released its inaugural First In Human (FIH) manufacturing batch in compliance with current Good Manufacturing Practice (cGMP) standards in its recently expanded Geneva mammalian cell manufacturing facility. The swift execution of this important milestone demonstrates the capabilities in cell line development (CLD) and biologics manufacturing of KBI and Selexis, allowing clients to accelerate clinical research timelines.
In July 2022, KBI and Selexis announced the completion of the fully integrated, 8,733 square-meter site combining Selexis’ Cell Line Development services and KBI’s development and manufacturing services. This milestone comes only five months after starting operations at the combined facility.
“Delivering this first batch affirms KBI’s commitment to helping pharmaceutical and biotechnology companies across the world achieve their manufacturing goals,” said Mike Landau, Chief Operating Officer of KBI and Selexis. “KBI and Selexis are leading CDMO and cell line development partners, supporting researchers in their efforts to provide groundbreaking therapies for patients in need.”
“ProMIS Neuroscience had a great experience with the Geneva KBI team in developing the process and producing cGMP clinical trial drug substance on time. The KBI team consistently collaborated with ProMIS in an integrated and strategic manner that produced the drug substance with the required quality attributes and exceeded expectations on yield. We are looking forward to our next engagement,” said Gavin Malenfant, Chief Operating Officer of ProMIS Neurosciences Incorporated.
The Geneva KBI and Selexis facility features integrated services including CLD services, analytical formulation services and clinical manufacturing, all under one roof. KBI and Selexis partner with biopharma leaders in developing treatments for a variety of therapeutic areas.
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.
Selexis SA, a JSR Life Sciences company, is a global leader in mammalian cell line development, with best-in-class modular technology and highly specialized solutions that enable the life sciences industry to rapidly discover, develop, and commercialize innovative medicines and vaccines. Our global partners are utilizing Selexis technologies to advance more than 160 drug candidates in preclinical and clinical development and the manufacture of ten commercial products. As part of a comprehensive drug development process, Selexis technologies shorten development timelines and reduce manufacturing risks. More information is available at www.selexis.com.