FDA Virus Stocks Prepared at ATCC Designated as WHO-CBER International Reference Reagents for Use in High-throughput Sequencing Technologies
ATCC Receives New FDA Contracts to Produce Additional Purified Virus Stocks for Use as Reference Materials
Manassas, VA, United StatesApril 21, 2021
ATCC, the world’s premier biological materials management and standards organization, today announced that five high-quality, concentrated virus preparations that it produced and stored under contract from the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (FDA/CBER) have been designated as international reference reagents for high-throughput sequencing technologies by the World Health Organization (WHO). The WHO made the designation following advice from its Expert Committee on Biological Standardization (ECBS) at the committee’s October 2020 72nd meeting. This initiative resulted in the preparation of the five viruses, which are the first products made at ATCC to be declared WHO international reference reagents.
ATCC also announced today that it has received two new five-year contracts from the FDA to develop seven purified virus preparations over the next 12 months. FDA/CBER ensures the safety, effectiveness and quality of biological products that are used in the United States, including vaccines, allergenics, blood and blood products, and cells, tissues and gene therapies.
“The selection of these five virus preparations as WHO international reference reagents is noteworthy,” said Dr. Raymond Cypess, DVM, Ph.D., chairman and CEO of ATCC. “Not only do they offer the quality control and reliability that’s essential in the use of high-throughput sequencing technologies, but their designation underscores the strength of ATCC’s ongoing commitment to move credible science forward for the benefit human life.”
High-throughput sequencing technologies are used for life-saving scientific research, diagnostics and determining treatment in the practice of precision medicine. The five CBER virus preparations recently designated as WHO international reference reagents for use in high-throughput sequencing technologies for adventitious virus detection in biological products are Porcine circovirus type 1(CBER-SC-VR-6000P), Mammalian orthoreovirus type 1 (CBER-SC-VR-6001P), Feline leukemia virus (CBER-SC-VR-6002P), Human respiratory syncytial virus (CBER-SC-VR-6003P), and Epstein-Barr virus (CBER-SC-VR-6004P). These preparations are available by request to FDA/CBER.
“The new contracts continue ATCC’s long history of supporting key U.S. Department of Health and Human Services agencies of which FDA is a part,” said Dr. Joseph Leonelli, vice president of ATCC Federal Solutions. “Importantly, they enable us to carry on our important work to bring the highest quality materials to the world’s life science community.”
The two new FDA contracts reflect ATCC’s ongoing partnership with the federal government to provide and support research, development, and testing programs in emerging and infectious diseases.
ATCC is a premier global biological materials and information resource and standards organization and the leading developer and supplier of authenticated cells lines and microorganisms. With a history of scientific advancements spanning nearly a century, ATCC offers an unmatched combination of being the world’s largest and most diverse collection of biological research solutions and a mission-driven, trusted partner that supports and encourages scientific collaboration. ATCC products, services, and people provide the scientific community with credible biological products, advanced model systems, and custom solutions that support complex research in a variety of innovative applications resulting in incredible achievements in basic science, drug discovery, translational medicine, and public health. ATCC is a non-profit organization with headquarters in Manassas, VA, and an R&D innovation center in Gaithersburg, MD.
Contact: Kim Testa, senior director, Corporate Communications & Public Affairs, ATCC, 703-365-2700 ext. 2753