Bio-Techne Partners with USP to Enhance Quality Standards for Monoclonal Antibody and Gene Therapy Development
核心洞察
Bio-Techne Corporation (搜索) announced a distribution agreement with the U.S. Pharmacopeia (搜索) (USP) to sell monoclonal antibody (搜索) and AAV reference standards alongside its analytical solutions globally.
The collaboration addresses critical quality challenges in biotherapeutic development, particularly as more than 160 antibody therapies have been approved worldwide and biosimilar competition increases.
Gene therapy represents one of the fastest-growing biopharmaceutical sectors, offering cures for previously incurable genetic diseases (搜索) despite facing development challenges including low yields and analytical complexities.
Bio-Techne Corporation (搜索) has entered into a strategic distribution agreement with the U.S. Pharmacopeia (搜索) (USP) to accelerate the development of monoclonal antibody (搜索) and gene therapy products worldwide. The collaboration enables Bio-Techne to distribute USP monoclonal antibody (mAb) and recombinant adeno-associated virus (AAV) reference standards alongside its analytical solutions, including the Maurice system.
Addressing Critical Quality Challenges in Biotherapeutics
The partnership comes at a crucial time for the biopharmaceutical industry, with more than 160 antibody therapies targeting nearly 100 different targets and diseases having received worldwide approval. Maintaining consistent mAb quality has become increasingly vital as patent protections expire and biosimilar versions enter the market, creating greater demand for rigorous testing of critical quality attributes throughout development and manufacturing processes.
"We are excited about our work with USP. This marks a significant milestone in advancing our commitment to providing cutting-edge tools and solutions to the scientific community," said Will Geist, President of Bio-Techne's Protein Sciences Segment. "This relationship underscores our dedication to supporting advancements in biotherapeutic development and ensuring the highest standards of quality and safety for patient care."
Gene Therapy Development Acceleration
Gene therapy, which relies on recombinant AAV to deliver gene edits into cells, represents one of the fastest-growing sectors in the biopharmaceutical industry. These groundbreaking treatments offer potential cures for previously incurable genetic diseases (搜索), though significant challenges persist in development and commercialization, including low yields, scalability hurdles, high costs, and analytical complexities.
USP reference standards address these challenges by providing well-characterized benchmarks for analytical testing, ensuring accuracy, reliability, and regulatory compliance throughout product development and quality control processes.
Integrated Analytical Solutions
The collaboration combines USP's stringent reference materials with Bio-Techne's leading analytical instruments, particularly the MauriceFlex system. This integration enables therapy manufacturers to achieve reliable, efficient characterization for purity, charge, size, and identity applications for complex biologics throughout the entire development lifecycle, from initial development through product release.
"We are thrilled to engage Bio-Techne as an authorized distributor, which enables USP to expand access of our solutions within the scientific community and beyond, ensuring that safe and quality therapeutic products reach the market for the benefit of patients worldwide," said Fouad Atouf, Ph.D., Senior Vice President, Global Biologics for USP.
Streamlined Method Development
The ability to purchase USP reference standards directly from Bio-Techne simplifies the method development process for customers, enabling them to assess system suitability and other critical criteria for charge and size-based analytical assays on the Maurice system. Both organizations bring extensive experience in developing solutions for mAb support and are now applying their expertise to solve analytical challenges in AAV-based gene therapies.
Bio-Techne Corporation (搜索), a global life sciences company with approximately $1.2 billion in net sales in fiscal 2024 and around 3,100 employees worldwide, provides innovative tools and bioactive reagents for research and clinical diagnostic communities. The company's extensive portfolio includes hundreds of thousands of products supporting scientific investigations into biological processes and disease progression.