ATCC and USP Launch First Set of Products to Advance Quality and Reduce Risk in the Development of Biological Therapeutics and Vaccines
MANASSAS, Va. and ROCKVILLE, Md., Oct. 30, 2023 /PRNewswire/ -- Today, ATCC and U.S. Pharmacopeia (USP), two premier materials management and standards organizations, announced the launch of their first set of joint products to advance the quality control and reduce the risk in the manufacturing of biological therapies and vaccines. This initial set of six products consists of highly characterized and pure genomic DNA (gDNA) from cell lines used in bioproduction that can be used to measure residual host cell DNA in various biotherapeutic products, as required by regulatory authorities. The presence of gDNA is a predominant concern in the development of biological therapies as it can pose a safety risk if it is not removed from the product.
- MANASSAS, Va. and ROCKVILLE, Md., Oct. 30, 2023 /PRNewswire/ -- Today, ATCC and U.S. Pharmacopeia ( USP ), two premier materials management and standards organizations, announced the launch of their first set of joint products to advance the quality control and reduce the risk in the manufacturing of biological therapies and vaccines.
- The presence of gDNA is a predominant concern in the development of biological therapies as it can pose a safety risk if it is not removed from the product.
- 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."
- The first set of products from ATCC and USP allows users to test the drug substance and process intermediates to assess clearance of residual gDNA with analytical reference materials derived from an authenticated cell line.