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Challenges and Pathways in Regulating Next-Gen Biological Therapies

23 Apr 2025

Abstract excerpt

BACKGROUND: Current medicine could benefit from gene and cell therapies for genetic defects, cancer, and degenerative disorders. These therapies modify genetic material or biological components. CRISPR-Cas9 gene editing, stem cell, and CAR-T treatments are examples. Complex products need rigorous regulations to ensure quality, efficacy, and patient safety. OBJECTIVES: This paper discusses international gene and...

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PMID: 40277057
DOI: 10.2174/0113892010367028250411111549

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