MANASSAS, Va.--(BUSINESS WIRE)--ATCC, the world’s premier biological materials management and standards organization, today announced that it has been awarded a task order with a ceiling value of $15.5 million, inclusive of base and options, by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Under this task order 75N93019D00002-75N93024F00001, ATCC will develop well-characterized challenge material (WCCM) for the In Vitro Assessment for Antimicrobial Activity (IVAAA) program. This program aims to evaluate candidate countermeasures against microbial pathogens and vectors, including those derived from clinical specimens. The assessments are conducted in vitro and focus on antiviral screening assays for biosafety level (BSL)-3/4 viruses relevant to human diseases, as well as other rapidly emerging viruses that employ similar assay methodologies.
Due to the rise in countermeasures requiring the use of well-characterized viral stocks for animal studies and human clinical trials, researchers are examining the potential impact of cell substrates on the genetic stability and quality of progeny virus following serial propagation. In mammalian cells, serially propagating viruses can lead to rapid increases in genetic variants and instability, which have been shown to impact the interpretation of data from animal studies as well as from clinical trials. Ensuring the genomic homogeneity of WCCM, as well as improving the production capacity of WCCM used in drug screening studies, is essential for therapeutic drug development.
“The production of well-characterized challenge material has become one of ATCC’s essential capabilities ever since the COVID-19 pandemic,” said ATCC chairman and CEO Raymond H. Cypess, DVM, PhD. “We have optimized production methods through the analysis of multiple cell lines and the selection of those that maintain the quality of progeny virus. As a well-established standards organization, ATCC is committed to providing scientists with the biomaterials and resources they need to conduct critical life science research.”
To fulfill this task order, ATCC will oversee the production of WCCM BSL-3/4 viruses by acquiring different clinical isolates and cell lines (human and nonhuman primate origin) from BEI Resources or other sources that NIAID deems acceptable. ATCC will perform numerous optimization studies on a small scale to determine the best conditions for in vitro propagation of the viral pathogens before proceeding to engineering and production runs.
“During the engineering phase, manufacturing occurs at a larger scale (compared to optimization studies). This is done to ensure that the conditions remain consistent and meet our stringent quality specifications,” said Rebecca Bradford, MBA, MS, Vice President of Government Programs within ATCC Federal Solutions. “We will accelerate NIAID’s pandemic preparedness efforts with the development of methodologies to produce and characterize WCCMs used to support assay reproducibility and efficacy studies of current and future countermeasures.”
“Partnering with government agencies like NIAID to advance global health aligns with our mission,” said Joseph Leonelli, PhD, Senior Vice President and general manager of ATCC Federal Solutions. “ATCC continues to mobilize and support discoveries within the global scientific community that can combat emergent health issues and benefit humanity.”
The project is funded by federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Task Order No. 75N93019D00002/75N93024F00001.
About ATCC
ATCC is a premier global biological materials and information resource and standards organization and the leading developer and supplier of authenticated cell lines, microorganisms, and associated data for academia, industry, and government. With a history of scientific contributions spanning nearly a century, ATCC offers an unmatched combination of being the world’s largest and most diverse collection of biological reference materials and data, and is a mission-driven, trusted partner that supports and encourages scientific collaboration. ATCC products, services, partnerships, and people provide the global scientific community with credible, advanced model systems to support complex research and innovations in basic science, drug discovery, translational medicine, and public health. ATCC is a 501(c)3 nonprofit organization with headquarters in Manassas, Virginia, and a research and technology center of excellence in Gaithersburg, Maryland. To learn more, visit atcc.org.