Wednesday, August 29, 2018
KBI Biopharma, Inc. announced today that its subsidiary KBI Biopharma BVBA has begun operations at its new laboratories in Leuven, Belgium. The laboratories are co-hosted with JSR Life Sciences' Amsphere ™ A3 European manufacturing site and represent KBI's leading European-based service offering. KBI Biopharma BVBA launched its first client-sponsored programs in May 2018.
KBI Biopharma BVBA has GMP and non-GMP service capabilities, including analytical development, formulation development, biopharmaceutical characterization and GMP-compliant quality control testing, for the release and stability of the drug substance and product. pharmaceutical.
"One of the key assets of this new facility is the use of our existing procedures and knowledge bases," said Cale Halbleib, PhD, director of biopharmaceutical development, at KBI Biopharma BVBA. "Our Leuven site is a European extension of KBI's proven expertise in GMP development and testing. We can now, in both the United States and Europe, take advantage of these capabilities, which include the transfer and co-validation of analytical methods for clients. "
"The establishment of our analytical services laboratory in Belgium is a key strategic goal for KBI," said Tim Kelly, PhD, President and CEO of KBI Biopharma, Inc. "With this expansion, we are strengthening our outstanding foundation in analytics so as to provide an even more comprehensive solution for our partner clients seeking to conduct clinical trials and register their products in the EU and the US "
To date, KBI has helped develop more than 300 molecules for more than 70 unique health indications. By expanding its footprint in Europe, KBI will continue to accelerate an even wider range of drug development programs for its global customer base.
