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One Stop Solution for IND Filing

Stages Regular CMC FAST CMC FDAReady/EMAReady CMC
Cell Banking
Process Development (PD) NA NA
Small Scale Production NA
Analytical Development (AD)/Project Specific Qualification (PSQ) NA
Pilot Scale Production
Stability Study

Project Experience

  • CAR-T, TCR-T
  • CAR-NK
  • CRISPR editing
  • AAV based therapy
  • mRNA vaccine
  • Virus vaccine
  • DNA vaccine
  • LeverDNATM

Technical Advantages

Strains & helper plasmids


  • Licensed strains with sublicense

Ready-to-use helper plasmids

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

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