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Analysis and Quality Study
Services
  • 01
    Plasmid specific analytical development：Plasmid supercoiled ratio, identity by restriction digest, linearized plasmid purity, etc.
  • 02
    Plasmid non-specific analytical procedures：Appearance, pH, plasmid content, residual host-cell DNA, residual host-cell protein, residual host-cell RNA, residual antibiotics, bacterial endotoxin test, sterility test, etc.
  • 03
    mRNA-specific analytical procedures：mRNA content, mRNA purity, mRNA integrity, mRNA capping rate, mRNA tailing rate, residual double-stranded RNA, etc.
  • 04
    mRNA non-specific analytical procedures：Appearance, pH, residual DNA, residual proteins, bacterial endotoxin test, sterility test, etc.
  • 05
    Specific analytical procedures for LNP-encapsulated drug products：Assay, purity, encapsulation efficiency, etc.
  • 06
    Specific analytical procedures for LNP-encapsulated drug products：Appearance, pH, particle size, etc.
  • 07
    Drug quality studies：including structural characteristics, purity, impurity analysis (process-related, product-related), in vitro and in vivo efficacy, immunogenicity profiles, etc.
  • 08
    Release test and stability study
Technical Advantages of the Platform
  • Development and optimization of comprehensive and stable plasmid and nucleic acid analysis methods
  • Skilled HPLC & LC-MS analytical procedure development for nucleic acid macromolecules
  • Skilled topological structure analysis of plasmids of different sizes，development of super helix analysis method for 4000bp-13000bp pDNA
  • The core backbone of the team has rich experience in IND application and process-related impurities, product-related impurities, and activity analysis
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