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Plasmid CDMO
Applications of Plasmids
Technical Advantages of the Platform
  • 1 L -500 L high-flexibility scale
    GMP plasmid manufacturing
  • Animal-free, antibiotic-free high-density fermentation, 24h plasmid copies ≥ 1 g/L
  • Industrializable continuous lysis process with a high recovery rate
  • Supercoiled Plasmid ≥95%
  • DoE meets customized needs according to product characteristics
  • Mature IND clinical application experience (AAV, CAR-T, Stem cells, etc.)
Technology Platform Route
Overall Research Customization for CMC

With rich experience in IND application and GMP manufacturing for multiple plasmids, we assist customers' projects to enter the clinical trial stage quickly, and provide customers with an overall solution from plasmid construction to IND document writing, meeting the IND application requirements of NMPA, FDA and EMA.

  • Plasmid Construction
    Vector design and construction
  • Construction of High-Expression Cell Bank
    RCB MCB WCB
  • Process Development Optimization

    Upstream process development,

    Downstream process development,
    Lab-scale production and testing


  • Analytical Method and Quality Studies
    Establishment of analytical method, Confirmation of analytical method
  • Pilot-Scale Production and Release
    Plasmid pilot-scale GMP batch production and release testing
  • Stability Study
    Interfering fact, acceleration and long-term stability studies
  • IND Application
    CTD format data writing for IND application
Technology Transfer and GMP Manufacturing Services
  • 1
    Perfect technology transfer process, scientific and reasonable evaluation systems for the undertaken process
  • 2
    Comprehensive technology transfer risk assessment and management control procedures, quickly completing different transfer requirements, and promoting the implementation of the project
  • 3
    High-quality GMP control system, ensuring legitimacy, compliance and traceability of GMP activities
  • 4
    Multiple plasmid GMP production lines, unidirectional single-use and non-single-use production lines are available to effectively reduce cross-contamination and waiting period
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