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Secretion of therapeutic proteins refers to the biological processes by which recombinant or endogenous proteins are translocated from producer cells into the extracellular space or bloodstream for therapeutic benefit. In pharmaceutical biotechnology, harnessing cellular secretory pathways, primarily the classical endoplasmic reticulum (ER)-to-Golgi-to-plasma membrane route as well as non-classical pathways (such as exosomes or direct translocation), enables systemic delivery of biotherapeutics (including antibodies, hormones, enzymes, and cytokines). This process relies on protein signal sequences, post-translational modifications, vesicular trafficking, and specialized quality control mechanisms. Improper or dysregulated secretion can lead to reduced therapeutic efficacy, ER stress, or cellular toxicity, and specialized engineering (e.g., optimizing signal peptides) is an area of ongoing research to improve systemic bioavailability and reduce side effects.
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