Bio-Techne Partners with USP to Enhance Antibody and Gene Therapy Development
In a significant move set to advance the field of biopharmaceuticals, Bio-Techne Corporation has entered into a collaborative agreement with the U.S. Pharmacopeia (USP) aimed at optimizing the development and commercialization of monoclonal antibodies (mAbs) and gene therapies. This partnership allows Bio-Techne to distribute USP's reference standards for monoclonal antibodies and recombinant adeno-associated viruses (AAV), thereby integrating with its state-of-the-art analytical solutions, including the MauriceFlex™ system.
Background on Monoclonal Antibodies and Gene Therapy
Monoclonal antibodies have established themselves as vital tools in combating a myriad of diseases, with over 160 antibody therapies now approved globally, targeting nearly 100 different conditions. As the exclusivity of these therapies wanes due to patent expirations, the rise of biosimilars necessitates rigorous testing throughout the mAb manufacturing and quality assurance processes. The new biosimilars, which are designed to mirror original biologics, require enhanced scrutiny to ensure their safety and efficacy.
On the other hand, gene therapy is gaining traction as one of the fastest-expanding sectors within the biopharmaceutical landscape. Utilizing AAVs for gene delivery into cells, innovations in this area promise transformative treatments for previously untreatable genetic disorders. Nevertheless, developers face numerous obstacles, including scalability issues, high production costs, and the inherent complexities of analytical testing.
Role of USP Reference Standards
USP’s established reference standards serve as critical benchmarks for analytical testing, facilitating reliable and compliant product development and quality control processes. These standards are designed to ensure consistency and reliability, addressing the pressing need for high-quality inputs amid the rapid evolution of biotherapeutics. By using these noted reference materials, companies can enhance their analytical capabilities, significantly streamlining the development cycles for both mAbs and gene therapies.
Bio-Techne's sophisticated instruments can utilize these stringent USP standards to deliver fast and effective characterization of biologics. This is crucial for assessing quality attributes such as purity, charge, and size—all fundamental characteristics for efficient mAb and gene therapy production.
Statements from Company Leaders
Will Geist, the President of Bio-Techne's Protein Sciences Segment, expressed enthusiasm regarding the collaboration, stating, "This partnership represents a pivotal leap forward in our efforts to equip the scientific community with cutting-edge tools and solutions." Geist emphasized that this agreement underpins Bio-Techne's dedication to fostering advancements in biotherapeutic development, pivotal for ensuring patient safety and product quality.
Fouad Atouf, Ph.D., Senior Vice President for Global Biologics at USP, echoed similar sentiments, highlighting the broader implications of the collaboration: "Teaming up with Bio-Techne allows USP to enhance the accessibility of our solutions, ensuring that high-quality therapeutic products reach consumers safely and effectively." Atouf’s remarks signal a commitment to tackling prevalent quality challenges, leveraging USP's robust framework of scientific standards to support pharmaceutical manufacturers.
Conclusion and Looking Forward
The agreement between Bio-Techne and USP spotlights the critical intersection of innovation and compliance in the biopharmaceutical industry. By making USP's reference standards available through Bio-Techne's renowned analytical platforms, the partnership addresses vital industry needs while streamlining operational processes. The capacity for mAb and gene therapy developers to access these high-quality materials efficiently marks an essential step toward enhancing product safety and efficacy in biotherapeutic markets worldwide. This collaboration is expected to inspire further developments in the pursuit of excellence in biopharmaceutical manufacturing and regulatory compliance.
Background on Monoclonal Antibodies and Gene Therapy
Monoclonal antibodies have established themselves as vital tools in combating a myriad of diseases, with over 160 antibody therapies now approved globally, targeting nearly 100 different conditions. As the exclusivity of these therapies wanes due to patent expirations, the rise of biosimilars necessitates rigorous testing throughout the mAb manufacturing and quality assurance processes. The new biosimilars, which are designed to mirror original biologics, require enhanced scrutiny to ensure their safety and efficacy.
On the other hand, gene therapy is gaining traction as one of the fastest-expanding sectors within the biopharmaceutical landscape. Utilizing AAVs for gene delivery into cells, innovations in this area promise transformative treatments for previously untreatable genetic disorders. Nevertheless, developers face numerous obstacles, including scalability issues, high production costs, and the inherent complexities of analytical testing.
Role of USP Reference Standards
USP’s established reference standards serve as critical benchmarks for analytical testing, facilitating reliable and compliant product development and quality control processes. These standards are designed to ensure consistency and reliability, addressing the pressing need for high-quality inputs amid the rapid evolution of biotherapeutics. By using these noted reference materials, companies can enhance their analytical capabilities, significantly streamlining the development cycles for both mAbs and gene therapies.
Bio-Techne's sophisticated instruments can utilize these stringent USP standards to deliver fast and effective characterization of biologics. This is crucial for assessing quality attributes such as purity, charge, and size—all fundamental characteristics for efficient mAb and gene therapy production.
Statements from Company Leaders
Will Geist, the President of Bio-Techne's Protein Sciences Segment, expressed enthusiasm regarding the collaboration, stating, "This partnership represents a pivotal leap forward in our efforts to equip the scientific community with cutting-edge tools and solutions." Geist emphasized that this agreement underpins Bio-Techne's dedication to fostering advancements in biotherapeutic development, pivotal for ensuring patient safety and product quality.
Fouad Atouf, Ph.D., Senior Vice President for Global Biologics at USP, echoed similar sentiments, highlighting the broader implications of the collaboration: "Teaming up with Bio-Techne allows USP to enhance the accessibility of our solutions, ensuring that high-quality therapeutic products reach consumers safely and effectively." Atouf’s remarks signal a commitment to tackling prevalent quality challenges, leveraging USP's robust framework of scientific standards to support pharmaceutical manufacturers.
Conclusion and Looking Forward
The agreement between Bio-Techne and USP spotlights the critical intersection of innovation and compliance in the biopharmaceutical industry. By making USP's reference standards available through Bio-Techne's renowned analytical platforms, the partnership addresses vital industry needs while streamlining operational processes. The capacity for mAb and gene therapy developers to access these high-quality materials efficiently marks an essential step toward enhancing product safety and efficacy in biotherapeutic markets worldwide. This collaboration is expected to inspire further developments in the pursuit of excellence in biopharmaceutical manufacturing and regulatory compliance.
Topics Health）
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