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Overview
mRNA Product Quality Assurance
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Quality check guarantees the purity and quality of desired products. It is the key to maintain Sanyou’ s outstanding customer satisfaction throughout our 10-year journey.
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Sanyou Bio employs the industry-level quality control rubrics for our mRNA products, offering our customers either standard or premium choice of services.
mRNA -Quality Standards
QC | Service | Standard | Premium |
|---|
Identification | Appearance | Clear, transparent, no precipitation | Clear, transparent, no precipitation |
RNA Length (Agarose Gel Electrophoresis) | Clear band at right size | Clear band at right size | |
PolyA Length | N/A | √ | |
RNA Concentration | >1 mg/mL | >1 mg/mL | |
Purity | A260/280 | 2.0-2.3 | 2.0-2.3 |
Encapsulation Efficiency | N/A | ＞90% | |
Purity（HPLC） | ＞90% | ＞90% | |
Protein Residue | N/A | ＜5% | |
dsRNA | N/A | ＜5% | |
Safety | Endotoxin (Semi-quantitative) | N/A | <10 EU/mg |
Function | Cell Transfection | N/A | √ |
mRNA Quality Inspection
1) dsRNA Detection
2) T7 RNA Polymerase Detection
Example dsRNA quality and T7 RNA polymerase detection of mRNA prepared by Sanyou Bio mRNA IVT kit.
LNP-Quality Standards
Service | Method | Standard |
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Appearance | Visual Inspection | Clarity, no residue |
Target Concentration | RiboGreen Fluorescent Dye Inspection | 0.1 –0.4 mg/mL |
Packaging Efficiency | RiboGreen Fluorescent Dye Inspection | >85% |
Integrity of Packaged RNA | Capillary Electrophoresis | >75% |
Particle Size | Dynamic Light Scattering | POI ±20 nm , 65 -125 nm |
Polymer Dispersity Index (PDI) | Dynamic Light Scattering | <0.2 |
Zeta potential | Laser Doppler Electrophoresis | ±15.0 mV |
pH | pH Strip/pH Meter | 7.4 ±0.5 |
Endotoxin | Semi-quantitative | <4 EU/mL |
Quantitative | <4 EU/mL |
LNP Quality Inspection
1) Size distribution by intensity
2) Zeta potential distribution
Example size distribution and Zeta potential distribution of mRNA-LNP prepared by Sanyou Bio selected LNP packaging.
