mRNA/LNP Analytics & QC

• Test content:Full-length sequence determination: Using high-fidelity RNA-seq technology, the full-length mRNA sequence is completely analyzed to verify the accuracy of the coding and uncoding (UTR) sequences and to screen for sequence abnormalities such as point mutations, deletions, and insertions;

• Isomer analysis: For complex mRNA molecules, identify the types and proportions of alternative splicing isomers and assess their impact on drug function;

Sequence consistency verification: Compare mRNA sequences from different production batches and under different storage conditions to ensure sequence stability between batches and within the shelf life;

Technical advantages: Sequencing coverage > 99%, sequence alignment accuracy ≥ 99%, and can accurately capture low-abundance sequence variations.

• Detection capabilities: It can accurately identify extremely rare variants with low frequency (such as rare point mutations, chimeric sequences, and degradation-related variants).

• Technical support: The system employs ultra-deep sequencing combined with proprietary bioinformatics algorithms to effectively filter background noise and improve the accuracy of rare variant detection.

The integrity of RNA molecules directly determines their translation efficiency and therapeutic effect, and is a key indicator for quality control of RNA therapy .

Full-length integrity verification: The full-length ratio of mRNA/siRNA molecules is assessed by capillary electrophoresis and RNA-seq coverage analysis to identify truncated and degradation products;

Secondary structure stability analysis: An RNA folding prediction algorithm combined with experimental verification was used to assess the integrity of the RNA molecule's secondary structure, avoiding the impact of structural abnormalities on delivery and function;