In 2025, the biopharmaceutical industry shifted towards precision and standardization, moving CAR-T cell manufacturing inside the patient.
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The rise of in vivo CAR-T therapies transformed Advanced Therapy Medicinal Products by allowing the patient's immune system to produce the therapeutic effect.
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The FDA Modernization Act 2.0 prompted a shift from animal testing to New Approach Methodologies, addressing the reproducibility crisis in drug discovery.
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The industrialization of organoid technologies aimed to standardize protocols and improve predictability in preclinical validation.
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The convergence of engineering principles in cell therapy and drug discovery is leading to more accessible therapies and improved predictability in outcomes.