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Plasmid CDMO Services

  • Industrial Leading Timeline

    • Fast turnaround to meet your demanding timeline
      • Plasmid for early clinic: as fast as 4 weeks from strain construction to batch release
      • Plasmid for late clinic & commercial: as fast as 5 weeks from GMP manufacturing to batch release

  • Guaranteed Delivery

    • Guaranteed plasmid quantity and quality – no surprises or hidden costs
    • Dual plasmid manufacturing in US and CN for resilient supply chain and risk mitigation

  • Application-specific Solution

    • Ultra small scale ( 50 mg~200mg) plasmid offering for early-phase trial with no excess waste
    • Excellent ITR integrity (>90%) with proprietary PowerS™-ITRrs strain for AAV transfer plasmid
    • High performing PowerS™-DNA⁺ strain for DNA vaccine with up to 3 g/L

Phase-appropriete Plasmid Manufacturing Service

  • GMP-Principle grade: cost-effective adoption for early clinical phases
  • GMP grade: highest quality, full GMP environment for late clinical and commercial stages
IND
Phase I
Phase II
Phase III
BLA
Commercial
IND CMC
GMP-Principle*
GMP Grade
BLA PC/PV
GMP Grade

* IND Pro for FDA & EMA; GMPro™ for NMPA (China), FDA & EMA

GMP-Principle GMP Plasmid
Animal Free √ √
Antibiotic Free √ √
Fermentation Process √ √
Alkaline Lysis √ √
Chromatographic Purification √ √
CoA (QC Report) √ √
TSE/BSE Statement √ √
Manufacturing Summary Report √ √
E. coli Cell Banking √ √
Process Development,
At-Scale Engineering Run		 √

Proprietary Strains for Various Downstream Applications

Related Service

  • Contact us
  • Phone: 1-877-436-7274 (Toll-Free); 1-732-885-9188
  • Fax: 1-732-210-0262