The two-component nanoparticle adjuvant is a nano-adjuvant system based on QS-7 and QS-21 fractions (water-soluble saponins). It achieves synergistic delivery of dual adjuvants via nanocage particle technology, effectively enhancing immune responses and vaccine efficacy.Prepared using nanocage particle technology, the adjuvant features uniform particle size (PDI < 0.2) with a diameter of 40 nm. It appears as a colorless, transparent ready-to-use solution, which can be directly mixed with antigens (suitable for reconstitution of lyophilized vaccines).
II. Technical Parameters
| Item | Specification | | Components | QS-7 fraction + QS-21 fraction | | Particle size distribution | 28–45 nm (PDI < 0.2) | | pH value | 6.8–7.4 | | Shelf life | 2 years (stored at 2–8 °C, protected from light) |
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Figure 1 Schematic diagram of particle size distributio
| Item | Average | Standard Deviation | Relative Standard Deviation | Minimum | Maximum | | Z-Average (nm) | 40.09 | - | -
| 40.09 | 40.09 | | Polydispersity Index (PI) | 0.0528 | -
| -
| 0.0528 | 0.0528 | | Area Mean Diameter of Volume-weighted Distribution (nm) | 42.65 | -
| -
| 42.65 | 42.65 | | Intercept | 0.9798 | -
| -
| 0.9798 | 0.9798 | | Polydispersity | 0.001553 | -
| -
| 0.001553 | 0.001553 |
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Figure 2 Transmission electron microscopy (TEM) image
III. Product Information
1. Components: Core raw materials are QS-7 fraction (purity ≥95%) and QS-21 fraction (purity ≥98%) extracted from Quillaja saponaria. All materials comply with EMA Guidelines on Adjuvant Quality and WHO Prequalification (PQ) requirements.
2. Manufacturing and Testing: Each component is tested to meet strict internal standards, including component identification and batch consistency.The adjuvant is manufactured in a GMP-grade cleanroom via a tightly controlled nanocage particle preparation process, with batch-to-batch consistency CV < 5%.Sterility is ensured by 0.22 μm sterile filtration during production. Stability is verified by accelerated testing (25 °C / 75% RH, 3 months), with active ingredient retention >85% and particle size variation <10%.
3. Immune ResponseThe adjuvant activates immune responses through multiple synergistic pathways.It promotes the differentiation of CD4⁺ T cells into Th1, Th2, and T follicular helper (Tfh) cells, and induces the generation of CD8⁺ memory T cells.By upregulating co-stimulatory molecules and MHC molecules, it activates CD4⁺ T cells via the MHC class II pathway and CD8⁺ T cells via MHC class I cross-presentation.In addition, the two components trigger the NLRP3 inflammasome pathway, releasing key cytokines such as IL-1β and IL-18 to further enhance immune effects.
4. Safety: This product presents the following hazards: If swallowed, it may enter the respiratory tract (fatal risk). May cause skin allergic reactions. Causes serious eye irritation.
5. Verified ApplicationsCOVID-19 vaccines; Malaria vaccines
6. Recommended Compatibility Ratios of Two-Component Nanoparticle Adjuvant with Different Antigens
| Vaccine Type | Antigen | Antigen: Adjuvant Ratio | | COVID-19 Vaccine | NVX-CoV2373 (S-protein trimer) | 5 μg: 50 μg (1:10) | | Influenza Vaccine | HA Protein (H1N1/H3N2/B Strain) | 15 μg: 50 μg (1:3.3) | | Malaria Vaccine | R21 Antigen (Circumsporozoite Protein) | 5 μg: 50 μg (1:10) | | HIV Vaccine | gp120 Protein | 10 μg: 25 μg (1:2.5) | | RSV Vaccine | F Protein Nanoparticle | 60 μg: 50 μg (1:1.2) |
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Note: The concentration of the two-component nanoparticle adjuvant is 100 μg/mL.
7. Recommended Dosage
Recommended injection volume of antigen/adjuvant mixture at different administration sites in laboratory animals
| Species | Maximum Volume | | Mouse | 50 μL | | Rat | 100 μL | | Guinea pig | 200 μL | | Rabbit | 200 μL | | Human | 500 μL |
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