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Labs are co-located with JSR Life Sciences’ Amsphere A3 European mfg. site & represent KBI’s first Europe service offerings
August 29, 2018
By: Betsy Louda
KBI Biopharma announced that its subsidiary KBI Biopharma BVBA has begun operations at its newly completed laboratories in Leuven, Belgium. The laboratories are co-located with JSR Life Sciences’ Amsphere A3 European manufacturing site and represent KBI’s first service offering based in Europe. KBI Biopharma BVBA initiated its first client-sponsored programs in May 2018. KBI Biopharma BVBA has capabilities for GMP and non-GMP services including analytical development, formulation development, biopharmaceutical characterization and cGMP quality control testing for release and stability of drug substance and drug product. “A key strength of this new facility is the utilization of our existing procedures and knowledge base,” said Cale Halbleib, PhD, director of Biopharmaceutical Development at KBI Biopharma BVBA. “Our Leuven site is a European extension of KBI’s well-established development and GMP testing expertise. We can now leverage those capabilities in both the US and EU including transfer and co-validation of analytical methods for customers.” “The establishment of our analytical services laboratory in Belgium is a key strategic objective for KBI,” said president and chief executive officer of KBI Biopharma, Inc., Tim Kelly, PhD. “Through this expansion, we are building on our exceptional foundation in analytical sciences to offer an even more comprehensive solution to our client partners who seek to conduct clinical trials and register their products in the EU and US.” To date, KBI has helped to advance more than 300 molecules in more than 70 unique health indications. By expanding its footprint into Europe, KBI will continue to accelerate an even broader range of drug development programs for its global client base.
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