Exosome Research Services: Biomarkers for Drug Development

Exosomes are a type of extracellular vesicle. RNA and proteins contained within exosomes serve as biomarkers for a wide range of diseases. We support our clients’ drug development by providing a comprehensive suite of assays, ranging from the identification of exosomal marker antigens to the analysis of study samples.

What Are Exosomes?

Exosomes are a class of extracellular vesicles (EVs) secreted by various cell types in the body and are recognized as mediators of intercellular communication. These vesicles, surrounded by a lipid bilayer membrane, are found in biological fluids such as blood, saliva, urine, and breast milk. Exosomes contain RNA and proteins derived from their host cells, and by transferring these cargoes between cells, they play an important role in cell-to-cell signaling. Due to these properties, exosomes are expected to have applications in both disease diagnosis and treatment.

Exosomes as Biomarkers

Exosomes attract significant attention as biomarkers for a wide range of diseases, including cancer and central nervous system disorders. Potential applications include elucidating disease states and mechanisms, developing biomarkers for drug efficacy and safety, patient stratification (companion diagnostics, CDx), and predicting treatment outcomes. Compared to direct analysis of biomarkers in blood or other body fluids, exosome analysis can provide more precise information about the origin of the biomarkers. Liquid biopsy of exosomes offers a less invasive method for monitoring biomarker levels, reducing the burden on patients compared to traditional biopsy procedures.

Exosomes in Regenerative Medicine

Mesenchymal stem cells (MSCs) demonstrate various therapeutic effects, and it is increasingly recognized that some of these effects are mediated by exosomes secreted by MSCs.

Exosomes as Drug Delivery Systems (DDS)

Exosomes possess lipid bilayer membranes and display various surface markers. Leveraging these properties, exosomes are being explored as drug delivery systems (DDS), particularly for delivering unstable nucleic acid drugs to cancer cells in cancer therapy.

Our Services

We provide research support services for drug development, focusing on the use of exosomes as biomarkers.

Expected Uses Targets Methods
  • Elucidation of pathology and disease mechanisms.
  • Development of efficacy and safety biomarkers
  • Patient stratification (CDx).
  • Prediction of treatment effectiveness
Amount (number) and size of exosomes
  • Preparation and purification of exosomes (ultracentrifugation, various commercial kits)
  • Determination of particle number and size (tRPS)
Proteins
  • Total protein quantification (BCA)
  • Membrane surface marker analysis (Western blot)
  • Protein analysis (NanoLC-HRMS)
  • Target-protein quantification (ELISA, CLEIA, ECLIA).
Genes
  • Total RNA quantification (Qubit)
  • MicroRNA quantification (RT-PCR, Digital PCR)
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    Please note:These services are for research purposes only and are not intended for diagnostic use.

Examples of Research Support for Exosome-Based Drug Efficacy and Safety Biomarkers

  • 1.
    Identification of Marker Antigens:
    Exploration of indicator antigens for immunoprecipitation purification or immunoassay quantification (e.g., LC-MS/MS, Western blot).
  • 2.
    Antibody Screening:
    Screening of antibodies using ELISA to confirm antibody reactivity with minimal impact on exosome integrity.
  • 3.
    Development of Purification Methods:
    Development of methods for purifying tissue-specific exosomes (immunoprecipitation) and quantitative assays of cargo molecules (e.g., ELISA, PCR).
  • 4.
    Method Validation:
    Validation of analytical methods (performance assessment).
  • 5.
    Test Sample Analysis:
    Analysis of test samples in compliance with GLP.

Contact Us for Services