ATCC, the world’s premier biological materials management and standards organization and U.S. Pharmacopeia (USP), an independent, international, and scientific nonprofit organization, today announced a long-term, multi-year strategic collaboration to jointly provide co-branded reference materials and reference standards that will serve to advance the quality and development of biologic medicines and therapies.

“By combining our strengths, we can better support institutions and stakeholders that engage in R&D, process development, and release of biologics, as well as provide them with quality products that meet their needs,” said Raymond H. Cypess, DVM, PhD, chairman and CEO of ATCC. “This collaboration also offers solutions that customers can rely on to mitigate their regulatory acceptance risks and accelerate commercialization of new therapies.”

“Our goal, together with ATCC, is to provide robust and innovative solutions that ensure our customers feel confident that the answers they get are reproducible and accurate, and ultimately can provide safe biologic therapies to patients who depend on them,” said Ronald T. Piervincenzi, PhD, CEO of USP. “This agreement begins with the first of many potential product areas for our organizations to provide standards and other solutions.”

The initial set of products ATCC and USP will launch together include genomic DNA from top cell lines used in bioproduction. Measurement of cellular DNA left over following purification is required by regulatory authorities to ensure product safety. Two of the items support the most common platforms used in the rapidly growing cell and gene therapy sector. These products will be followed by another portfolio centered around the detection of contaminant microbes, another safety concern. Rapid detection of viruses, bacteria, and other pathogens which might be introduced into the manufacturing stream is particularly important for cell and gene therapies, where rapid administration of small batches with a short shelf life are critical.

These innovative products require a multi-pronged approach to accelerate their development and release to patients. USP and ATCC’s collaboration recognizes these challenges and combining the know-how of both organizations will empower better solutions. This robust portfolio of resources will help industry stakeholders break down barriers in development and manufacturing of biologic medicines and therapies while upholding their quality and reducing regulatory risks.

“As innovation in health and medicine advances, ensuring the safety and quality of biologic medicines and therapies is critical to building the public’s trust,” said Amanda Cowley, general counsel and SVP Legal, Strategy and People of USP. “Both USP and ATCC have been essential to improving and securing public health and we are prepared to use our combined experience to continue to support the supply of quality medicines so patients can have access to the medications they need when they need it.”

“This is a transformative, strategic collaboration that is consistent with both of our non-profit missions and global reach,” said Ruth Cheng, PhD, senior vice president and general manager, Research & Industrial Solutions. “Healthcare and medicine are changing rapidly, and this agreement is just one example of the innovative ways that ATCC and USP are working to meet future needs.”

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 and follow us on Facebook, LinkedIn, or Twitter.

About USP

USP is an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality resources and standards for medicines, dietary supplements, and food ingredients. Through our resources, standards, advocacy, and education, USP helps ensure the availability of quality medicines, supplements, and foods for billions of people worldwide. Learn more at www.usp.org.

Contacts:
Kim Testa, senior director, Corporate Communications & Public Affairs, ATCC, [email protected]
Darienne Gutierrez, senior manager, Strategic Communications, USP, [email protected]