Bio-Techne and USP Announce Collaboration to Accelerate Monoclonal Antibody and Gene Therapy Product Development
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.
Bio-Techne (NASDAQ: TECH) ha annunciato un accordo strategico di distribuzione con la U.S. Pharmacopeia (USP) per la vendita di standard di riferimento USP per anticorpi monoclonali (mAb) e virus adeno-associati ricombinanti (AAV), da affiancare alle sue soluzioni analitiche, incluso il sistema Maurice.
La collaborazione mira a supportare lo sviluppo di prodotti a base di anticorpi monoclonali e terapie geniche a livello globale. Con oltre 160 terapie a base di anticorpi approvate a livello mondiale, la partnership risponde alle esigenze critiche di controllo qualità sia nello sviluppo di mAb sia nel settore in rapida crescita delle terapie geniche. L’integrazione degli standard di riferimento USP con gli strumenti analitici di Bio-Techne consentirà ai produttori di terapie di ottenere una caratterizzazione affidabile per purezza, carica, dimensione e identità durante tutto il processo di sviluppo del prodotto.
Bio-Techne (NASDAQ: TECH) ha anunciado un acuerdo estratégico de distribución con la U.S. Pharmacopeia (USP) para vender estándares de referencia USP de anticuerpos monoclonales (mAb) y virus adenoasociados recombinantes (AAV) junto con sus soluciones analíticas, incluido el sistema Maurice.
La colaboración tiene como objetivo apoyar el desarrollo de productos basados en anticuerpos monoclonales y terapias génicas a nivel mundial. Con más de 160 terapias de anticuerpos aprobadas globalmente, la asociación responde a las necesidades críticas de control de calidad tanto en el desarrollo de mAb como en el sector de terapias génicas en rápido crecimiento. La integración de los estándares de referencia USP con los instrumentos analíticos de Bio-Techne permitirá a los fabricantes de terapias lograr una caracterización confiable en pureza, carga, tamaño e identidad a lo largo del desarrollo del producto.
Bio-Techne (NASDAQ: TECH)는 미국 약전(USP)과 전략적 유통 계약을 체결하여 USP 단클론 항체(mAb) 및 재조합 아데노연관 바이러스(AAV) 참조 표준을 자사의 분석 솔루션인 Maurice 시스템과 함께 판매한다고 발표했습니다.
이번 협력은 전 세계적으로 단클론 항체 및 유전자 치료제 개발을 지원하는 것을 목표로 합니다. 전 세계적으로 160개 이상의 승인된 항체 치료제가 있는 가운데, 이 파트너십은 mAb 개발과 빠르게 성장하는 유전자 치료 분야 모두에서 중요한 품질 관리 요구를 충족합니다. USP 참조 표준과 Bio-Techne의 분석 기기를 통합함으로써 치료제 제조업체는 제품 개발 전반에 걸쳐 순도, 전하, 크기 및 동일성에 대한 신뢰할 수 있는 특성 평가를 수행할 수 있게 됩니다.
Bio-Techne (NASDAQ : TECH) a annoncé un accord stratégique de distribution avec la U.S. Pharmacopeia (USP) pour commercialiser les standards de référence USP d’anticorps monoclonaux (mAb) et de virus adéno-associés recombinants (AAV), en complément de ses solutions analytiques, notamment le système Maurice.
Cette collaboration vise à soutenir le développement de produits à base d’anticorps monoclonaux et de thérapies géniques à l’échelle mondiale. Avec plus de 160 thérapies à base d’anticorps approuvées dans le monde, ce partenariat répond aux besoins critiques de contrôle qualité tant dans le développement des mAb que dans le secteur en pleine croissance des thérapies géniques. L’intégration des standards de référence USP avec les instruments analytiques de Bio-Techne permettra aux fabricants de thérapies d’obtenir une caractérisation fiable de la pureté, de la charge, de la taille et de l’identité tout au long du développement du produit.
Bio-Techne (NASDAQ: TECH) hat eine strategische Vertriebsvereinbarung mit der U.S. Pharmacopeia (USP) bekanntgegeben, um USP-Monoklonale-Antikörper (mAb) und rekombinante adeno-assoziierte Virus (AAV) Referenzstandards zusammen mit seinen analytischen Lösungen, einschließlich des Maurice-Systems, zu vertreiben.
Die Zusammenarbeit zielt darauf ab, die Entwicklung von monoklonalen Antikörper- und Gentherapieprodukten weltweit zu unterstützen. Mit über 160 zugelassenen Antikörpertherapien weltweit adressiert die Partnerschaft kritische Qualitätskontrollanforderungen sowohl in der mAb-Entwicklung als auch im schnell wachsenden Gentherapiebereich. Die Integration der USP-Referenzstandards mit den analytischen Instrumenten von Bio-Techne ermöglicht es Herstellern von Therapien, eine zuverlässige Charakterisierung bezüglich Reinheit, Ladung, Größe und Identität während der Produktentwicklung zu erreichen.
- 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
- None.
Insights
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.
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
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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FAQ
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