ATCC and BioAgilytix Announce Partnership to Develop Custom Cell-based Assay Solutions to Support Biopharmaceutical R&D

Combined expertise will create best-in-class assay systems for drug potency, stability testing and other applications

MANASSAS, Va. and DURHAM, N.C., October 18, 2016 — ATCC, a global leader in biological materials development, management and standards, and BioAgilytix, a leading provider of contract testing services with a specialization in biologics, today announced a strategic partnership to develop new and custom cell-based assays to accelerate and enhance biopharmaceutical research and development.

The partnership combines ATCC’s deep expertise in developing, authenticating, banking, and provisioning cells with BioAgilytix’s world-class capabilities in the development, validation and execution of cell-based assays. Under the agreement, ATCC will offer tool and reagent development and storage services, including custom-engineered cell lines and primary cells, as a complement to the broad array of assay solutions offered by BioAgilytix. Assays will include those used to establish the potency and stability of therapeutic products and help establish their safety and efficacy profiles.

As part of the relationship, ATCC will take a minority equity stake in BioAgilytix and serve on its commercial advisory board.

“We believe this partnership will offer significant value to the biopharmaceutical industry,” said Dr. Raymond H. Cypess, ATCC CEO. “The synergies created by combining our recognized expertise in cell line development, storage, management and distribution with the impressive bioanalytical capabilities of BioAgilytix will help advance the progress of innovative therapies for patients in need around the world.”

As a premier CRO specializing in assay development and validation for biotherapeutics, BioAgilytix has established a worldwide reputation for solving complex large molecule challenges, and currently supports 23 of the top 25 global pharmaceutical and biotechnology companies.

“To be the best possible partner for our clients, we constantly seek out new opportunities to deliver even greater value and best-in-class services,” said Jim Datin, BioAgilytix CEO. “ATCC’s 90 years of experience and state-of-the-art biorepository operations are a perfect complement to our capabilities. This new partnership will further our ability to deliver industry-leading cell-based assay solutions for drug potency, stability testing and other applications to our clients.”

About ATCC

ATCC is a leader in biological materials management, providing the worldwide scientific community and U.S. government with research and development, products, and services in support of global health issues. With a history of innovation spanning more than 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, and an R&D and services center in Gaithersburg, MD.

About BioAgilytix

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.