Customers Have Access to a Joint Team with Expertise Ranging from Research to Good Manufacturing Practice (GMP)
FEBRUARY 28, 2017—Durham, NC—BioAgilytix, a leading provider of contract bioanalytical testing services with specialization in large molecule bioanalysis, is progressing its strategic partnership with ATCC, a global leader in biological materials development, management and standards, to offer full service cell-based assay development, validation, and execution capabilities to pharmaceutical and biotechnology sponsors. The partnership, which was first announced in October 2016, has already proven effective for customers seeking a single, comprehensive solution for their cell-based assay work. These sponsors have access to ATCC’s research-focused services for developing, authenticating, banking, and provisioning cells, and BioAgilytix’s robust expertise developing new and custom cell-based assays, including those for drug potency and stability testing under Good Manufacturing Practice (GMP). The two organizations bring complementary expertise and resources to deliver a seamless solution for accessing, developing, characterizing, and storing cell lines, and developing, validating, and performing robust cell-based assays in which they will be used.
“Even in the few months since forging our partnership with ATCC, we’ve already seen the added value that we have been able to provide to customers as a ‘one-stop-shop’ solution for their cell-based assay development needs,” said Jim Datin, CEO of BioAgilytix. “We can leverage ATCC’s deep experience in cell line constructs and cell characterization on the front end, and then apply our deep expertise delivering cell-based assay solutions to support all phases of discovery through validation and sample analysis for product release under GMP. We can be a true end to end partner for sponsors, from providing high-capacity storage for cell banking and access to special, rare, and specific tissue and cell lines via ATCC, to developing custom pre-screening and discovery, NAb, and potency assays through our own lab.”
BioAgilytix and ATCC will continue to build upon the success of their new partnership in the coming months, working together to identify additional opportunities to better serve biopharmaceutical researchers through their joint services and expertise. “We believe there is tremendous value in the synergies we’ve developed between the BioAgilytix and ATCC teams, and look forward to applying our combined expertise to support and solve our customers’ most complex cell-based assay challenges.”
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.
ATCC is a leader in biological materials management supporting the scientific community and government with research and development, products, and services in support of global health issues. With a history of innovation spanning 90 years, ATCC offers the world’s largest and most diverse collection of human and animal cell lines, microorganisms, biological products, and standards. ATCC is a non-profit organization with headquarters in Manassas, Va. For more information about ATCC, visit us at www.atcc.org.