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(1) Regulatory and scalability gaps: standardized protocols for polymeric carrier scalability, sterilization, and long-term stability are lacking, with advanced systems (e.g., PEGylated uricase and biomimetic nanosystems) requiring rigorous immunogenicity (anti-drug antibodies) and cost-effectiveness evaluations

, 26 , 1021-1032, doi: Santana-Codina, N., and Mancias, J

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