Bio-Techne and USP Forge Strategic Alliance to Advance Quality Standards in Monoclonal Antibody and Gene Therapy Development
Bio-Techne Corporation, a global life sciences company renowned for its high-performance reagents, instruments, and services, today announced a new distribution agreement with the United States Pharmacopeia (USP), a scientific nonprofit organization that sets public standards for the identity, strength, quality, and purity of medicines and biologics. This collaborative arrangement allows Bio-Techne to distribute USP’s reference standards for monoclonal antibodies (mAbs) and recombinant adeno-associated viruses (AAVs) alongside its advanced analytical platforms—most notably the MauriceFlex™ system.
This alliance aims to address mounting challenges in the development and commercialization of mAb therapies and gene therapies, particularly those involving AAV vectors. By combining USP’s rigorously characterized reference materials with Bio-Techne’s user-friendly, high-resolution analytical instruments, the collaboration intends to streamline workflows, improve data accuracy, and enable greater compliance with global regulatory expectations.
Responding to the Growing Demand for Quality in Biologics
The global therapeutic landscape has undergone a profound transformation over the past two decades. Biologic drugs, including monoclonal antibodies, have become essential in the treatment of a wide array of conditions, from autoimmune diseases to various cancers. To date, more than 160 monoclonal antibody therapies targeting nearly 100 disease-related proteins have received regulatory approval globally. As demand for these therapies continues to surge, particularly with the emergence of biosimilars, the necessity for strict quality controls during development and manufacturing becomes paramount.
One of the principal concerns in biologics manufacturing is product consistency—ensuring that every batch meets stringent criteria for purity, identity, charge, and molecular size. These attributes not only determine a drug’s safety and efficacy but also influence its regulatory approval and post-market success. The expiration of patents on numerous first-generation mAbs has led to increased competition in the form of biosimilars, which further amplifies the importance of robust analytical tools capable of detecting subtle differences between original biologics and their follow-on versions.
In this context, the USP’s mAb reference standards offer pharmaceutical manufacturers a critical benchmark. These standards are widely recognized by regulatory agencies such as the FDA and EMA for use in analytical method development, validation, and quality control. With Bio-Techne’s global distribution network and integrated analytical platforms like the MauriceFlex™, more laboratories can now seamlessly adopt these standards into their workflows.
Driving Innovation in Gene Therapy with AAV Standards
While monoclonal antibodies are well-established in the clinical setting, gene therapies represent the vanguard of modern medical innovation. By correcting or replacing faulty genes responsible for genetic disorders, gene therapy offers a potentially curative approach for diseases once deemed untreatable. A significant proportion of gene therapies currently in development utilize recombinant adeno-associated virus (rAAV) vectors due to their favorable safety profile and ability to effectively deliver genetic material to target cells.
However, the gene therapy sector faces its own unique set of obstacles. These include low production yields, challenges in achieving consistent vector potency, high production costs, and a lack of standardized analytical tools. Given the complexity of AAVs—biological particles with intricate structures and highly variable compositions—ensuring consistent quality from batch to batch is no easy feat. Here too, USP’s AAV reference standards play a pivotal role by offering well-characterized materials that serve as a benchmark for analytical assays.
By offering these standards alongside Bio-Techne’s MauriceFlex™ system—a state-of-the-art platform that combines capillary electrophoresis with multi-dimensional characterization capabilities—the partnership delivers a powerful, unified solution for developers of gene therapies. Researchers can efficiently assess critical quality attributes such as vector integrity, purity, and size distribution throughout the development and manufacturing lifecycle.
MauriceFlex™: Bridging Compliance and Efficiency
The MauriceFlex™ system, part of Bio-Techne’s ProteinSimple product line, represents a next-generation approach to biologics characterization. Unlike conventional manual or semi-automated techniques, MauriceFlex™ offers a fast, fully automated solution capable of analyzing multiple parameters from a single sample. With built-in modules for size, charge, and identity assessment, the platform supports method development, system suitability testing, and lot release in both research and Good Manufacturing Practice (GMP) environments.
Importantly, when paired with USP reference standards, MauriceFlex™ enables scientists to quickly determine whether their assay methods meet key quality criteria—such as resolution, precision, and reproducibility. The streamlined compatibility between instrument and standard minimizes guesswork and method variability, which is especially valuable in time-sensitive drug development timelines.
“By integrating USP’s trusted reference materials with Bio-Techne’s Maurice system, therapy developers now have a complete analytical solution that promotes speed, accuracy, and regulatory confidence,” said Will Geist, President of Bio-Techne’s Protein Sciences Segment. “We are proud to align with USP in our shared mission of elevating biotherapeutic quality worldwide.”
Expanding Access to Quality Standards Through Strategic Distribution
Under the terms of the agreement, Bio-Techne becomes an authorized distributor of USP’s mAb and AAV reference standards. This move is expected to expand access to these critical quality tools across the global biopharmaceutical ecosystem. Through Bio-Techne’s extensive commercial infrastructure, customers across North America, Europe, Asia, and emerging markets will be able to easily acquire USP standards alongside the company’s suite of analytical instruments and services.
“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,” said Fouad Atouf, Ph.D., Senior Vice President of Global Biologics at USP. “Through this collaboration, we’re reinforcing our commitment to advancing pharmaceutical quality by making science-based solutions more accessible and adaptable for developers of mAbs and gene therapies.”
Dr. Atouf further emphasized that the partnership reflects USP’s broader strategy of addressing prevalent quality issues in biopharmaceutical manufacturing with innovative, scalable tools. By leveraging the organization’s legacy of evidence-based standards and Bio-Techne’s robust technological capabilities, the partnership represents a meaningful step toward making safe, effective biologics more readily available to patients around the world.
A Shared Vision for Scientific Progress and Patient Benefit
Both organizations bring a legacy of scientific excellence and public health advocacy to this new partnership. USP, with its over 200-year history of establishing rigorous quality standards, plays a vital role in the global regulatory landscape. Bio-Techne, with its focus on high-precision tools and customer-centric innovation, has become a trusted partner for academic researchers, clinical labs, and biopharmaceutical developers alike.
Together, USP and Bio-Techne are well-positioned to respond to the pressing needs of an industry in flux. From supporting the rise of biosimilars to catalyzing the next wave of gene therapies, their collaboration embodies a forward-thinking approach to product development—one that prioritizes not only speed and efficiency, but also scientific integrity and patient safety.
As the biopharmaceutical industry continues its march toward greater complexity, personalization, and global reach, partnerships such as the one between Bio-Techne and USP will be instrumental in shaping the future. With this collaboration, the two organizations have laid the groundwork for an ecosystem where consistent, high-quality biologics can be developed more efficiently and brought to market with greater confidence.
For manufacturers, researchers, and regulators alike, this alliance represents more than a logistical convenience—it’s a blueprint for the next era of therapeutic innovation.
