CN
mRNA
mRNA
In Vitro mRNA Transcription Process Development
In Vitro mRNA Transcription Process Development

Comprehensive and efficient in vitro transcription process development platform

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Our service offerings:
  • Transcription Capped

    Material screening

    Enzyme, NTP, salt concentration optimization

    Reaction temperature and time optimization

  • Template Digestion

    Enzyme screening

    DNase I concentration optimization

    Reaction temperature and time optimization

  • Chromatography

    Resin screening

    Load screening

    Loading condition optimization

    Washing condition optimization

    Elution condition optimization

  • TFF

    Membrane pore size

    Transmembrane pressure and flux, ultrafiltration concentration

    Load

    Diafiltration volume

  • Process Scale-up

    Verification of process consistency with 3 consecutive batches

    Gap analysis between R&D and manufacture

    Technology transfer protocol determination

Our service offerings:
Service scope:
Service advantages:

  · Two mature mRNA drug substance platforms: co-transcriptional capping and post-transcription capping

  · For mRNA of different lengths and GC content, the platform process can achieve a yield of 9.0-11.0 mg/mL IVT

  · Advanced Oligo dT purification platform, with a variety of Oligo dT resins available

  · Process development can be completed in 4 weeks, and process qualification and technology transfer can be completed in 2 weeks

Key Equipment:
  • Thermostatic reactor
  • AKTA chromatography
  • TFF system
  • Biological Safety Cabinet