Bio-Techne and USP Announce Collaboration to Accelerate Monoclonal Antibody and Gene Therapy Product Development

Rhea-AI Summary

Bio-Techne (NASDAQ: TECH) has announced a strategic distribution agreement with the U.S. Pharmacopeia (USP) to sell USP monoclonal antibody (mAb) and recombinant adeno-associated virus (AAV) reference standards alongside its analytical solutions, including the Maurice system.

The collaboration aims to support the development of monoclonal antibody and gene therapy products worldwide. With over 160 approved antibody therapies globally, the partnership addresses critical quality control needs in both mAb development and the rapidly growing gene therapy sector. The integration of USP reference standards with Bio-Techne's analytical instruments will enable therapy manufacturers to achieve reliable characterization for purity, charge, size, and identity applications throughout product development.

Positive

• Strategic distribution agreement with USP enhances Bio-Techne's product offering
• Expands presence in the growing mAb and gene therapy markets
• Integration of USP standards with Bio-Techne's analytical instruments creates comprehensive solution
• Strengthens position in quality control and analytical testing market

Negative

• None.

Insights

Biotechnology Industry Analyst

Bio-Techne's USP partnership strengthens position in high-growth biologics analytics market, enhancing revenue opportunities in mAb and gene therapy development.

This strategic distribution agreement between Bio-Techne and USP represents a significant enhancement to Bio-Techne's product portfolio in the rapidly expanding biologics analytical testing market. By combining USP's gold-standard reference materials with Bio-Techne's Maurice analytical systems, the company has created an integrated solution addressing critical quality control challenges in both monoclonal antibody and gene therapy development.

The timing is particularly advantageous as the mAb market enters a biosimilar transition phase with numerous patents expiring, dramatically increasing demand for precise analytical testing to demonstrate bioequivalence. Meanwhile, the AAV-based gene therapy sector—despite its promising growth trajectory—faces substantial manufacturing and analytical bottlenecks that this partnership directly addresses.

From a competitive standpoint, this collaboration strengthens Bio-Techne's position against analytical instrumentation rivals by offering a more complete workflow solution. The USP partnership adds significant credibility through association with the organization that sets pharmaceutical standards in the United States.

For biopharma customers, the value proposition is compelling: simplified procurement, validated workflows, and potentially accelerated development timelines for complex biologics. This should drive increased adoption of Bio-Techne's Maurice platform across both established biopharma companies and the growing number of biotech startups focused on next-generation biologics.

The deal's strategic importance extends beyond immediate revenue opportunities—it positions Bio-Techne at the intersection of two major industry trends: the maturation of the mAb market with its shift toward biosimilars and the emergence of gene therapy as a revolutionary treatment modality requiring sophisticated analytical support.

MINNEAPOLIS, June 24, 2025 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced a distribution agreement with the U.S. Pharmacopeia (USP) that enables the Company to sell USP monoclonal antibody (mAb) and recombinant 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 groundbreaking 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.

"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."

"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. "Through working with Bio-Techne, USP is reinforcing its commitment to addressing the most prevalent quality issues with innovative solutions, leveraging our robust framework of science-based quality standards for pharmaceutical manufacturers."

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.

About Bio-Techne

Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne products assist scientific investigations into biological processes and the nature and progress of specific diseases. They aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses. With hundreds of thousands of products in its portfolio, Bio-Techne generated approximately $1.2 billion in net sales in fiscal 2024 and has approximately 3,100 employees worldwide. For more information on Bio-Techne and its brands, please visit http://www.bio-techne.com or follow the Company on social media at Facebook, LinkedIn, Twitter or YouTube.

About Bio-Techne Corporation (NASDAQ: TECH)
Contact: David Clair, Vice President, Investor Relations & Corporate Development
david.clair@bio-techne.com 
612-656-4416

USP does not approve, endorse or certify any particular brand or product, not does anything in this release imply that USP believes the equipment, instrument, or material is necessarily the best available for the purpose or that any other brand or product was judged to be unsatisfactory or inadequate.

 

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SOURCE Bio-Techne Corporation

FAQ

What is the significance of Bio-Techne's partnership with USP announced in June 2025?

The partnership allows Bio-Techne to sell USP's mAb and AAV reference standards with its analytical solutions, enabling more comprehensive quality control testing for biotherapeutic development.

How will the TECH and USP collaboration impact monoclonal antibody development?

The collaboration will help maintain consistent mAb quality by providing well-characterized benchmarks for analytical testing, especially important as biosimilar versions become available due to patent expirations.

What products are included in Bio-Techne's distribution agreement with USP?

The agreement covers USP monoclonal antibody (mAb) and recombinant adeno-associated virus (AAV) reference standards, which can be used with Bio-Techne's analytical instruments like the Maurice system.

How does the Bio-Techne and USP partnership address challenges in gene therapy development?

The partnership provides reference standards that help address challenges in gene therapy development including low yields, scalability issues, high costs, and analytical complexities by ensuring accuracy and regulatory compliance.

What analytical capabilities does Bio-Techne's Maurice system offer with USP standards?

The Maurice system, combined with USP standards, enables rapid and integrated characterization for purity, charge, size, and identity applications for complex biologics throughout development and product release.