The FDA’s recent announcement to phase out animal testing requirements for monoclonal antibodies and other drugs highlights a transformative moment in biopharmaceutical development. As the industry shifts toward more predictive, human-relevant testing methods, Abzena remains at the forefront, utilizing advanced computational tools and sophisticated human-based laboratory models. By embracing innovative in silico and in vitro technologies, Abzena is helping customers by providing them with the necessary data to meet regulatory expectations and an enhanced early-stage assessment of drug safety and efficacy that saves them significant time and resources. Here are five key insights into how Abzena’s cutting-edge approach aligns with this new regulatory landscape and can empower your therapeutic development pipeline.
1. Advanced Computational Studies: Accelerating Early Insights
Early-stage decision-making can significantly influence drug development timelines and costs. Abzena leverages advanced computational tools to provide critical insights long before laboratory testing. One key solution is iTopeAI™, a platform designed to predict immunogenicity risk is based on augmented intelligence, helping developers to rapidly assess potential anti-drug immune responses. Additionally, development is ongoing of a new in silico developability tool that will look to enhance early developability assessments by forecasting challenges around viscosity and aggregation, as well as initial predictions around stability, and pharmacokinetics. These predictive analyses will allow sponsors to identify and mitigate risks much earlier in the process, ultimately saving valuable resources and expediting development timelines.
2. Human-Based Lab Models: Enhancing Predictive Accuracy
As regulatory bodies like the FDA encourage the adoption of non-animal testing methods, advanced in vitro models have become essential tools for accurate safety and efficacy predictions. Abzena utilizes sophisticated human-based laboratory models, including complex 3D co-culture systems, to replicate human biology more faithfully than traditional animal studies.
Abzena’s collaboration with industry leaders, including Thermo Fisher and Sartorius, underscores its commitment to developing highly predictive, clinically relevant organoid models. For example, our compelling case study on Her2-targeting ADCs demonstrates our ability to inform clinical outcomes through advanced in vitro models. Additional case studies targeting Trop2 are also in development, further highlighting Abzena’s commitment to leading-edge, predictive efficacy modeling.
3. Bridging Safety and Toxicity Gaps
Ensuring patient safety through accurate toxicity predictions remains a cornerstone of drug development. With the FDA’s transition away from animal testing, the need for robust alternative models becomes even more pressing. Abzena is actively expanding its suite of advanced human-based in vitro and ex vivo assays to predict potential safety concerns accurately. This includes actively exploring opportunities to expand our suite of state-of-the-art cell and organoid models for assessing toxicity in key organs such as the liver, kidney, and skin. Our ongoing work involves identifying and refining the most predictive models available, providing comprehensive toxicity profiles that closely mirror human physiology.
4. Tailored Solutions for Immunogenicity and Pharmacokinetics (PK)
Beyond efficacy and general toxicity, immunogenicity and pharmacokinetics are crucial determinants of therapeutic success. Abzena offers specialized, targeted solutions for these areas. For immunogenicity, our proven platform iTopeAI™ and assays like EpiScreen® 2.0 provide precise insights into potential anti-drug immune responses, leveraging our extensive PBMC cell banks for comprehensive immunological profiling. Furthermore, information obtained using human PBMC-based assays is often likely to be far more meaningful regarding the potential for ADAs than from using other species e.g. mouse or cynomolgus monkeys.
For pharmacokinetic evaluations, Abzena employs ex vivo serum stability and FcRn binding assays, as well as developing recycling assays, and targeted liver and kidney uptake studies. Combined, these tools deliver deep insights into the drug’s stability, half-life, and biodistribution, further streamlining development and regulatory processes.
5. Thought Leadership in Non-Animal Drug Development
Abzena’s forward-looking strategy is not only aligned with the FDA’s latest guidance but also shapes industry standards. By proactively investing in advanced computational platforms, predictive cell models, and strategic partnerships, Abzena positions itself as a thought leader in the new era of non-animal drug development. These innovative methodologies provide sponsors with enhanced confidence in the safety, efficacy, and developability of their therapeutic candidates, effectively reducing risks and accelerating the path to clinical success.
Embracing the Future of Drug Development
As regulatory landscapes evolve, shifting away from traditional animal testing toward more predictive, human-relevant models, Abzena is already ahead of the curve. By harnessing advanced computational tools, sophisticated human-based lab models, and strategic industry partnerships, Abzena ensures your drug candidates are rigorously evaluated for safety, efficacy, and developability earlier and more accurately than ever before.
The FDA’s announcement is not merely a shift in testing requirements—it signifies a transformative moment in therapeutic innovation. Abzena is proud to lead the way, empowering our partners to confidently navigate this new era and accelerate groundbreaking therapies to patients faster.
Interested in learning how our advanced solutions can support your pipeline? Connect with our expert team today by visiting Abzena.com.
