Key Takeaways TECH struck a deal with USP to distribute mAb and AAV standards, alongside its Maurice analytics platform. TECH aims to ease analytical challenges in mAb and gene therapy development through this partnership. TECH's tools enable efficient, integrated analysis of complex biologics from development to product release.Bio-Techne Corp. (TECH) has recently entered into a distribution agreement with the U.S. Pharmacopeia (“USP”) to sell USP monoclonal antibody (mAb) and recombinant adeno-associate ...

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]