Plasmid Manufacturing

VectorBuilder can fulfill the full range of plasmid design, cloning and manufacturing needs throughout the gene therapy drug development pipeline. Relying on our revolutionary vector design platform and extensive experience, we can provide optimal vector designs tailored to a wide range of research and clinical needs. For plasmid DNA manufacturing, we offer several grades that cover different downstream needs including drug discovery research, pre-clinical studies, clinical trials and commercialization.

Different Grades of Plasmid DNA Offered
  • Research-grade plasmid

    Research-grade plasmid DNA is intended for basic research and drug discovery studies. It is made under standard laboratory conditions with stringent QC to ensure high quality suitable for all downstream research needs.

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  • GMP-like plasmid

    GMP-like plasmid DNA is intended for pre-clinical studies such as animal testing of drug safety and metabolism. It is produced in a manner that adopts key features of GMP guidelines, including comparable production process and similar quality attributes. Production is performed in segregated production suites with document control and traceability. GMP-like grade can thus be viewed as a small-scale mimic of the final GMP product, but with much lower cost and faster timeline. Where appropriate, GMP-like plasmid can be produced under antibiotic-free, animal component-free, and RNase-free fermentation and purification conditions. A certificate of analysis (COA) is provided at the product release. TSE/BSE statement is available upon request.

  • GMP plasmid

    GMP-grade plasmid DNA is produced in our certified GMP suite with strict adherence to GMP guidelines. A comprehensive quality assurance system is implemented throughout the production process. A wide range of in-process and release QC assays are performed to ensure that the plasmid DNA meets or exceeds the desired quality and safety standards. A batch release report fully documenting the production process and a COA are provided at product release. Other documentation is available upon request.

Workflow for GMP-like and GMP Plasmid Production
            
Quality Control Assays

The list below summarizes the main QC assays for the release of GMP plasmid. These assays are also available for GMP-like plasmid per customer request.

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  • General/physical properties

    Appearance, concentration, pH, extractable volume, osmolality, aggregation

  • Identity

    Restriction enzyme digestion, sequencing

  • Purity

    • OD260/280
    • Supercoiled plasmid ratio: agarose gel electrophoresis, capillary electrophoresis
    • Residual protein: BCA, SDS-PAGE
    • Host E. coli DNA: qPCR
    • Host E. coli RNA: agarose gel electrophoresis, RT-qPCR
    • Residual antibiotic: turbidmetric assay, immunoassay
  • Safety

    • Sterility: direct inoculation
    • Endotoxin: LAL assay
Stability Studies

Drug stability studies are performed following ICH guidelines. Forced degradation studies are performed to evaluate the influence of light, temperature, pH, etc., on the quality attributes of the plasmid DNA.

View here to learn more about our cell banking and fill/finish services

To inquire about our GMP manufacturing services email us a cdmo@vectorbuilder.com. For other questions contact us.