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Bio-Techne and USP Announce Collaboration to Accelerate Monoclonal Antibody and Gene Therapy Product Development
Prnewswire· 2025-06-24 11:00
Core Insights - Bio-Techne Corporation has entered into a distribution agreement with the U.S. Pharmacopeia (USP) to sell USP monoclonal antibody (mAb) and recombinant adeno-associated virus (AAV) reference standards, enhancing support for mAb and gene therapy development globally [1] - The need for consistent mAb quality is increasingly critical as patent protections expire and biosimilars emerge, necessitating rigorous testing of quality attributes during development and manufacturing [2] - Gene therapy, utilizing recombinant AAV, is rapidly growing but faces challenges such as low yields and high costs; USP reference standards provide benchmarks for analytical testing to ensure product quality [3] - USP mAbs and AAV reference standards can be used with Bio-Techne's analytical instruments, facilitating reliable characterization of complex biologics throughout the development process [4] - The collaboration between Bio-Techne and USP aims to address quality challenges in biotherapeutics, ensuring safety and efficacy for patient care [5] Company Overview - Bio-Techne Corporation is a global life sciences company that provides innovative tools and bioactive reagents for research and clinical diagnostics, generating approximately $1.2 billion in net sales in fiscal 2024 [6]