Home » CGT CDMO » Plasmid CDMO Services » Plasmid CMC for IND

One Stop Solution for IND Filing

Stages Regular CMC FAST CMC FDA/EMA IND Ready 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

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

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