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According to USP, the products will advance quality and reduce risk in the development and manufacture of biologics and vaccines.
The US Pharmacopeia (USP) announced on Oct. 30, 2023 that ATCC and USP have collaborated to create a set of joint products to advance quality control of biological therapies and vaccines. The six products include highly characterized and pure genomic DNA (gDNA) from cell lines. The cell lines can be used to measure residual host cell DNA; gDNA can pose a safety risk if not removed from the product.
These six products allow for the testing of drug substance and process intermediates to determine if residual gDNA has been cleared, using analytical reference materials derived from an authenticated cell line. Derived from host cell lines commonly used in the manufacture of vaccines and biologics, the products support the following platforms:
“Developing cutting-edge medicines in the biologics space requires trusted reference materials and standards to ensure quality, consistency, and safety,” said Amanda Cowley, general counsel and senior vice president Legal, Strategy and People of USP, in a press release. “With increased demands around the globe for new biological medicines on accelerated timelines, it’s essential that there are products and solutions that can be used to address and advance quality assessment and bring confidence to the development process. By focusing on the detection of gDNA, this first set of ATCC and USP products is significant for the future of biological development as it addresses a common concern when it comes to quality and mitigating risk.”
“This initial set of gDNA products are the first of many that will help ensure the quality and safety of biologic therapies which is of utmost importance not only to biopharmaceutical developers and manufacturers, but ultimately patients,” said Ruth Cheng, PhD, ATCC senior vice president and general manager, Research & Industrial Solutions, in the press release. “They trust us to provide them with reference materials and standards that produce reliable, reproducible, and comparable results, so they can deliver the next generation of high-quality and safe treatments to patients.”
ATCC, a global biological materials and standards organization, and USP are planning to release additional product portfolios that provide materials and standards for the development of biological therapies.