Bio-Techne Partners with USP to Enhance Biotherapeutic Standards Amid Rising Demand for Educational Development
- Bio-Techne and USP partnership aims to improve biopharmaceutical quality standards and enhance patient care through better testing.
- The collaboration provides manufacturers with reference standards for evaluating biologics, ensuring regulatory compliance and market readiness.
- Ascidian Therapeutics emphasizes clinical strategy and leadership in therapeutic development through new appointments and advisory boards.
### Advancing Biotherapeutics: Bio-Techne Partners with U.S. Pharmacopeia
Bio-Techne Corporation recently announces a strategic distribution agreement with the U.S. Pharmacopeia (USP) that allows the company to distribute USP monoclonal antibody (mAb) and recombinant adeno-associated virus (AAV) reference standards. This collaboration is set to enhance the quality and efficacy of biopharmaceuticals, particularly as the demand for monoclonal antibodies and gene therapies increases globally. With over 160 antibody therapies approved for nearly 100 targets, the partnership addresses the urgent need for consistent mAb quality, especially as patent protections expire and biosimilars enter the market. The rigorous testing of these therapies is crucial for ensuring patient safety and efficacy in an increasingly competitive landscape.
Bio-Techne's MauriceFlex™ system, which provides advanced analytical solutions, will integrate the USP reference standards to improve the assessment of biologics. These standards serve as well-characterized benchmarks, enabling manufacturers to effectively evaluate purity, charge, size, and identity from the development stage to product release. Will Geist, President of Bio-Techne's Protein Sciences Segment, underscores the significance of this collaboration in refining biotherapeutic quality standards and enhancing patient care. This partnership signals a commitment to advancing the biopharmaceutical industry, equipping manufacturers with the necessary tools to meet regulatory compliance and market demands.
Fouad Atouf, Senior Vice President at USP, joins Geist in expressing enthusiasm for the partnership, emphasizing its role in broadening access to high-quality therapeutic solutions for the scientific community and ultimately benefiting patients worldwide. Together, Bio-Techne and USP aim to set a new standard for the production and testing of biopharmaceuticals, which is critical in addressing the complexities of modern healthcare challenges.
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In related developments, Ascidian Therapeutics, a biotechnology firm, appoints Dr. Murray A. Abramson as Chief Development Officer, indicating a strong focus on clinical strategy for their lead therapy targeting Stargardt disease. The company also establishes an Ophthalmology Clinical Advisory Board to guide its clinical trial design, showcasing the industry's continued emphasis on leadership and innovation in therapeutic development.
Meanwhile, the American Camp Association concludes a three-year initiative aimed at enhancing character development in Counselors-in-Training (CIT) programs at medical specialty camps. This project, which engaged 12 camps worldwide, highlights the critical role of character development among adolescents and young adults with disabilities, reinforcing the importance of leadership and resilience in nurturing future leaders.
