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.
“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 SVP Legal, Strategy and People of USP. “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.”
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. These products and materials are derived from host cell lines commonly used in the manufacture of vaccines and biologics; they also support the most common platforms used in the rapidly growing cell and gene therapy sector:
- Quantitative Vero Genomic DNA
- Quantitative MDCK Genomic DNA
- Quantitative MRC-5 Genomic DNA
- Quantitative BHK-21 Genomic DNA
- Quantitative Sf9 Genomic DNA
- Quantitative HEK-293 Genomic DNA
The products have been manufactured, evaluated, and precisely quantitated using robust processes, thereby providing high-quality controls to effectively detect and measure gDNA and help mitigate risk in the development process. Application notes, describing the use of these materials with sensitive PCR-based protocols, are available to support laboratories with proven methods. This is done in accordance with current International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and USP General Chapters.
“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, Ph.D., ATCC Senior Vice President and General Manager, Research & Industrial Solutions. “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.”
The collaboration between ATCC and USP is an alliance between trusted leaders to deliver comprehensive quality assessment tools and solutions that increase confidence in the quality of medicine, including biologics, and reduce risk, from development through delivery. The products and offerings developed as part of this collaboration will combine products from the global premier provider of authenticated cell lines and microorganisms with standard-setting expertise to provide the biopharma industry with reliable products for biologics development and help facilitate product innovation and development. In addition to this first set of products, ATCC and USP will be releasing future product portfolios that provide materials and standards for the development of biological therapies.