Building Biotech: Animal Models and Beyond - What's Next?
Posted on 12 Feb 2026
How vaccine preclinical strategy is evolving as scientific, ethical, and regulatory pressures drive a move away from animal models toward more human-relevant approaches? .
In our recent feature with BioProcess International , we discuss how the usage of animal models and preclinical strategy is changing.
Access the Article: Animal Models and Beyond - What's Next?
Our writers, Senior Preclinical Consultant Subash Das and Managing Partner & Director Lee Smith, wrote this extensive article to cover:
- The historical and regulatory role of animal models in vaccine immunogenicity, efficacy, toxicology, and dose selection
- Scientific and translational limitations of animal models and their impact on clinical attrition
- Ethical pressures and policy frameworks shaping reduced animal use (3Rs, FDA Modernization Act 2.0, EMA guidance)
- Emerging alternatives, including organoids, microphysiological systems, and in-vitro assays
- Computational modelling, systems vaccinology, and AI-driven prediction of immune responses
- Humanised animal models as a refinement rather than a full replacement
- Adoption of New Approach Methodologies (NAMs) in potency testing, mechanism-of-action studies, and regulatory submissions
- Case examples of drugs and biologics supported or approved using NAM-heavy data packages
- The shift toward hybrid, phase-appropriate preclinical strategies combining in-vitro, in-silico, and targeted animal studies
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