One Stop Solution for IND Filing

Vector Construction
  • Gene synthesis & vector construction
Cell Banking
  • Screening of high-yield strains & PCB
  • Master Cell Bank (MCB) & Work Cell Bank (WCB) preparation
  • Stability test of WCB
Process Development
  • Upstream fermentation process establishment & optimization
  • Downstream purification process establishment & optimization
  • Verification run (reference preparation)
Analytical Development
  • Analytical method establishment
  • Analytical method qualification
Pilot Scale Production
  • Pilot scale production & Release
Stability Study
  • Accelerated stability investigation
  • Long-term stability investigation
  • Stability investigation of influencing factors
Dossier Summary
  • CTD format application materials

Project Experience

  • CAR-T, TCR-T
  • CAR-NK
  • CRISPR editing cell therapy
  • Gene therapy
  • mRNA vaccine
  • Virus vaccine
  • DNA vaccine
  • LcDNA

Technical Advantages

Strains & helper plasmids

Strains

  • Licensed strains with sublicense

Ready-to-use helper plasmids

  • DMF registered at FDA CBER
  • Clear history and IP free
  • Royalty free, maintenance free
Application
  • Cell therapy: Ready-to-use helper plasmids for 3rd generation LVV packaging
  • mRNA: Experience with plasmids with poly A tail length from 70 bp to 150 bp (over 15 projects)
  • lcDNA: cutting-edge technology with 3 projects ongoing
  • DNA vaccine: high concentration (20 mg/ml) for effective application

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