April 12, 2017—Durham, NC and Hamburg, Germany—BioAgilytix, a leading global provider of contract bioanalytical testing services with specialization in large molecule bioanalysis, has announced the official opening of its new European laboratory based in Hamburg, Germany. Construction of the new advanced facility began in mid-2016 following BioAgilytix’s acquisition of IPM Biotech, a leading European bioanalytical laboratory supporting large molecule bioanalysis. Located in Hamburg, Germany, the 1,765 sq. meter (18,998 sq. foot) facility greatly expands IPM Biotech’s former lab footprint and provides additional world-class resources for the European scientific team to use in conducting immunogenicity, pharmacokinetics (PK), cell-based assay, and biomarker studies supporting preclinical and clinical biological drug development. This new lab will serve as BioAgilytix’s European headquarters, providing robust capabilities to support all phases of large molecule global studies.
The opening of the new laboratory marks the next phase in BioAgilytix’s growth and mission to provide best-in-class large molecule services to customers across continents, offering ready access to top-caliber science and deep regulatory expertise at both its European and USA lab locations—and delivering consistent, high-quality results needed to bring biologics to market globally. Because the Hamburg lab conforms to all GLP requirements, it is an ideal location for European sponsors to support preclinical studies under GLP as all work can remain in the EU to avoid sample shipment issues such as CITES, import and export permits, etc. The laboratory is also equipped to progress such projects beyond the preclinical phase, with capabilities to support large clinical trials in compliance with GCP requirements for assay development, assay validation, and sample analysis.
“Our new laboratory was built to truly be one of the most technologically advanced bioanalytical laboratories in Europe supporting biological drug development,” said Dr. Arno Kromminga, Chief Scientific Officer, BioAgilytix Europe/IPM Biotech. “It further strengthens our ability, in partnership with BioAgilytix’s USA team, to be the single bioanalytical lab partner to pharma and biotech companies looking to efficiently progress their large molecule studies. To add to our scientific depth, we now have additional advanced technologies and added capacity which gives our team here the tools they need to further increase efficiencies and more seamlessly address customers’ scientific challenges.”
“This new facility marks an exciting evolution for our company as we continue our strategic, methodical growth with a steady focus on continual innovation, quality, and above all, customer satisfaction,” said Jim Datin, Chief Executive Officer of BioAgilytix. “We plan on adding even more breadth and depth of expertise to our European scientific bench to ensure we have the high-quality resources in place to best serve our customers’ evolving needs.”
BioAgilytix held an Opening Ceremony event, featuring a Bioanalytical Innovation Symposium, on March 23 to officially unveil the new IPM Biotech laboratory facility.###
BioAgilytix is a leading bioanalytical testing laboratory specializing in large molecule bioanalysis. With laboratory locations in North Carolina’s Research Triangle area and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of biologics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, spirit-of-GLP, GLP, GCP, and GCLP, as well as product release testing under GMP.
BioAgilytix’s team of highly experienced scientific and QA professionals ensures high quality science, data integrity, and regulatory compliance through all phases of clinical development, and is a trusted partner to 23 of the top 25 global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.
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