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The U.S. Food and Drug Administration (USFDA) has recently announced a significant shift in its approach to drug development by initiating a roadmap to phase-out traditional animal testing requirements. This move aims to incorporate New Approach Methodologies (NAMs), including AI-based models and other in vitro methods, to enhance drug safety, reduce research & development costs, and ultimately get medicines to patients faster.
This FDA development is particularly impactful for the field of monoclonal antibody (mAb) therapies, especially those administered subcutaneously. Subcutaneous (SC) delivery of mAbs offers numerous benefits, such as improved patient compliance and convenience. However, predicting the bioavailability and immunogenicity of SC-administered biologics has been challenging due to the complex nature of the subcutaneous tissue environment.
Traditional animal models have often fallen short in accurately simulating human SC tissue responses, leading to discrepancies in drug absorption and immune reactions. With the FDA's new stance, there is a pressing need for advanced in vitro models that can reliably predict human responses to SC mAb therapies.
One in vitro tool solely created for this purpose is Pion's Subcutaneous Injection Site Simulator (SCISSOR). Originally developed and validated primarily using mAbs, and now backed by 10+years of experience in in vitro subcutaneous testing, SCISSOR is designed to mimic the human subcutaneous environment—enabling researchers to compare drug release kinetics and potential immunogenicity risk in a controlled setting. By providing insights into how a drug behaves post-injection, SCISSOR aids in optimizing formulations and predicting clinical outcomes without relying on animal testing as outlined by a recent publication by AstraZeneca.
The FDA's initiative not only underscores the importance of developing and validating such human-relevant models but also opens avenues for their integration into the regulatory framework. As the agency plans to launch a pilot program allowing select mAb developers to utilize non-animal-based testing strategies, tools like SCISSOR are poised to play a pivotal role in shaping the future of drug development.
The FDA's move towards reducing animal testing marks a transformative period in pharmaceutical research. Embracing advanced in vitro models like SCISSOR will be crucial in ensuring the continued development of safe and effective SC mAb therapies, aligning with both ethical considerations and scientific advancements.
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