DNA Plasmid Vaccine Manufacturing

Raw Material Production Service

Raw Material Plasmids Suitable for Viral Production and Diagnostic Reagents

VGXI's Raw Material Production Service gives you high supercoil, low endotoxin plasmid preparations suitable for use as a raw material in cGMP manufacturing (e.g. viral production and diagnostic reagent manufacturing). This service employs the same patented manufacturing technology as our cGMP Production Service ensuring consistent, reliable quality.  Production is documented and a detailed certificate of analysis is provided.

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Applications

  • Viral production
  • Protein production
  • Diagnostic reagents

Features

  • 10-100L fermentation
  • Made using the same patented process as our cGMP Production Service
  • 100% of product delivered
  • Documented production
  • Detailed certificate of analysis
  • >95% supercoil
  • Purified to remove host cell RNA, protein, genomic DNA and endotoxins
  • Delivered in as little as 2 weeks
  • Shipped frozen overnight
  • Suitable for plasmids up to 15kb

QC Testing

  • Nucleic acid concentration by A260 absorbance
  • Purity by A260/280 ratio
  • Identity confirmation by restriction analysis
  • Structural integrity (% supercoiled DNA) by HPLC
  • Endotoxin level (LAL Assay)
  • Percent host cell contaminants
  • pH
  • Osmolality

Additional Services

  • Sterility/bioburden testing
  • Aseptic fill/finish
  • Process development