Plasmid Manufacturing Process

Plasmid Synthesis Service
Plasmid Construct
Fermentation
Harvest
Lysis
Chromatographic Purification
Quality Control and Release

Plasmid Platform – Excellent Track Record & Strong IP

  • Licensed Strain with Sublicensed Authority, clear IP and history
  • Internal & Compliance gene synthesis for plasmid construction, Clear History, Time and Cost Saving
  • Strong Track Record: from NMPA to FDA, from IND to BLA, from cell therapy to gene therapy and mRNA
  • Various Applications: CAR-T, TCR-T, CAR-NK, CRISPR editing cell therapy, Gene therapy, mRNA vaccine, Virus vaccine, DNA vaccine, LcDNA

Plasmid Manufacturing Service

IND
Phase I
Phase II
Phase III
BLA
Pre-Clinical
Commercial
GMP Grade
BLA CMC
GMP Grade
ProPlasmid
(Raw Material)
GMPro Plasmid
(Raw Material)
Clinical GMP Plasmid
(DS, DP)
GMP Plasmid
(Raw Material, DS, DP)
Animal Free
Antibiotic Free
Fermentation Process
Alkaline Lysi
Chromatographic Purification
CoA (QC Report)
TSE/BSE Statement
Manufacturing Summary Report
E. coli Cell Banking
Process Development,
At-Scale Engineering Run

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