Bio-Techne Corporation and U.S. Pharmacopeia Announce Collaboration to Accelerate Monoclonal Antibody and Gene Therapy Product Development

Published: 2025-06-24 08:35:54 ET TECH

Published on 06/24/2025 at 08:35

Bio-Techne Corporation announced a distribution agreement with the U.S. Pharmacopeia (USP) that enables the Company to sell USP monoclonal antibody (mAb) and recombant adeno-associated virus (AAV) reference standards with its analytical solutions, including the Maurice system, to support monoclonal antibody and gene therapy development around the world. More than 160 antibody therapies against nearly 100 targets and range of diseases have been approved worldwide. Maintaining consistent mAb quality is vital for their efficacy.

The need for consistency is becoming increasingly more important as mAb patent protections expire, and biosimilar versions of these therapies become available. This leads to a greater need for manufacturers to rigorously test critical quality attributes throughout mAb development and manufacturing processes to demonstrate product safety and effectiveness. Separately, gene therapy, which relies on recombinant AAV to deliver gene edits into cells, is one of the fastest-growing sectors in the biopharmaceutical industry.

The exceptional growth of these treatments offers cures to previously incurable genetic diseases; however, challenges persist in the development and commercialization processes, including low yields, scalability hurdles, high costs, and analytical complexities. USP reference standards help solve these challenges by providing well-characterized benchmarks for analytical testing, ensuring accuracy, reliability, and regulatory compliance in product development and quality control. Importantly, both USP mAbs and AAV reference standards provide stringent materials that can be used with Bio-Techne's leading analytical instruments, such as the MauriceFlex??

system. By combining these standards with the Company's rapid, easy-to-use, and multi-functional analytics, therapy manufacturers can achieve reliable, efficient, and integrated characterization for purity, charge, size, and identity applications for complex biologics, from development through product release. Addressing quality challenges is essential to ensure the safety and quality of biotherapeutics.

Both USP and Bio-Techne have a long history of developing solutions to support mAbs and are applying their know-how to solving analytical challenges in AAV-based gene therapies. The ability to purchase USP reference standards from Bio-Techne further simplifies the method development process, enabling customers to assess system suitability and other critical criteria for charge and size based analytical assays on the Maurice system.