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Secretion of therapeutic proteins

Molecular classification
Other
01

Overview

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.

Other names
Protein secretion pathwayTherapeutic protein secretionSecretion pathway for proteins
02

Biological functions

Protein traffickingPost-translational modificationCellular exportSignal transduction (for some secreted proteins)
03

Disease associations

Broadly relevant to all diseases treated with secreted therapeutic proteins, including cancer, inflammatory diseases, metabolic diseases, and genetic disorders
04

Safety considerations

Potential for immunogenicity when the secreted protein is non-native or misfoldedOverload or stress of the secretory pathway may cause cellular dysfunction or ER stress

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