BioAgilytix’s European Headquarters is Now Equipped to be Selected by Manufacturing and Product License Holders as a GMP Contract Laboratory
FEBRUARY 22, 2018—Hamburg, Germany—BioAgilytix, a leading provider of contract bioanalytical testing services with specialization in large molecule bioanalysis, has announced that its European headquarters, BioAgilytix Europe, has successfully accomplished preparations to be a GMP-compliant quality control testing laboratory for product and batch release testing of biologicals that are manufactured in accordance with GMP regulations. As a contract laboratory, BioAgilytix Europe does not require its own manufacturing license, but is ready to be named by manufacturing and product license holders as a contract laboratory performing quality control testing.
BioAgilytix’s staff was dedicated to ensuring that the new European facility would meet GMP requirements as a contract laboratory. “BioAgilytix has always placed a high priority on meeting and exceeding industry, regulatory, and quality standards,” said Anita Simkins, Vice President of Global Quality Assurance at BioAgilytix. “We are looking forward to working with our customers in Europe to support their GMP sample testing needs.”
“We are focused on solidifying our position as one of the most scientifically and technologically advanced bioanalytical laboratories in Europe supporting biological drug development,” said Dr. Arno Kromminga, Chief Scientific Officer, BioAgilytix Europe. “Meeting GMP compliance requirements marks the next milestone as we continue to grow and expand BioAgilytix Europe’s capabilities in quality control testing.”
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, GLP, and GCP, as well as GMP quality control testing (i.e. product release testing, stability testing, etc.).
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 many of the top global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.