KBI Biopharma BVBA Opent in Leuven, België, biedt Analytische diensten aan voor de Europese markt
DURHAM –(BUSINESS WIRE)– KBI Biopharma, Inc. kondigde vandaag aan dat haar dochteronderneming KBI Biopharma BVBA haar activiteiten is gestart in haar onlangss voltooide laboratoria in Leuven, België. De laboratoria zijn gehuisvest in de Europese productielocatie Amsphere™ A3 van JSR Life Sciences en vormen KBI’s eerste serviceaanbod in Europa. KBI Biopharma BVBA startte in mei 2018 haar eerste programma’s gesponsord door de klant.
KBI Biopharma BVBA heeft mogelijkheden voor GMP en niet-GMP de diensten met inbegrip van analytische ontwikkeling, formuleringsontwikkeling, biofarmaceutische karakterisering en cGMP kwaliteitscontrole het testen voor versie en stabiliteit van drugstof en drugproduct.
“Een belangrijke kracht van deze nieuwe faciliteit is het gebruik van onze bestaande procedures en kennisbasis”, aldus Cale Halbleib, PhD, Directeur biofarmaceutische Ontwikkeling bij KBI Biopharma BVBA. “Onze Leuvense vestiging is een Europese uitbreiding van KBI’s gevestigde expertise op het vlak van ontwikkeling en GMP-testen. Zowel in de VS als in de EU kunnen we nu de vruchten plukken van deze capaciteiten, met inbegrip van de overdracht en co-validatie van analysemethoden voor klanten.
KBI Biopharma BVBA Opens in Leuven, Belgium, Offering Analytical Services to the European Market
DURHAM, N.C.–(BUSINESS WIRE)– KBI Biopharma, Inc. announced today 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 CEO 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.
About KBI Biopharma, Inc.
KBI Biopharma is a biopharmaceutical Contract Development & Manufacturing Organization driven to accelerate the development of innovative discoveries into life-changing biological products and expand global access of medicines to patients in need.
From early-stage biotech to academic/non-profit organizations to many of the world’s largest pharmaceutical companies, KBI has served 300+ clients globally to accelerate and optimize their drug development programs.
KBI’s extensive track record of successful programs is a result of its unique approach: applying the insight gained from our advanced biophysical and analytical protein characterization techniques towards the development of robust and scalable processes. KBI delivers accelerated and integrated process development and cGMP manufacturing programs for a wide range of recombinant protein Active Pharmaceutical Ingredients (API) and cell therapies for our clients.
KBI was founded in 1996 and operates facilities in Durham and Research Triangle Park (NC), Boulder and Louisville (CO), The Woodlands (TX), San Diego (CA), and Leuven, Belgium.
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Contacts
For KBI Biopharma, Inc.
Missy Bindseil, 1-830-237-9527
mbindseil@jsrlifesciences.com