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Plasmid Manufacturing

VectorBuilder can fulfill the full range of plasmid design, cloning and manufacturing needs throughout the genetic medicine 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.

Grades of Plasmid DNA Offered

GMP-like plasmid for preclinical studies and GMP-grade plasmid for clinical and commercial use.
  • 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.

    Learn more about our research-grade plasmid
  • 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-grade 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.

Comparison of different grades of plasmid DNA

Research-grade GMP-like GMP-grade
Applications Basic research, drug discovery, preclinical studies Preclinical studies such as animal testing of drug safety and metabolism Preclinical studies, clinical studies, and commercialization
Production scales 10 ug to several 100 mg 10 mg to 1 g per batch 10 mg to 5 g per batch
Turnaround 1-8 days 1-3 months A few months to half a year
Quality system ISO9001 ISO9001 while adopting key features of GMP system ICH quality guidelines for GMP manufacturing
Production facility In parallel production in shared laboratory space Productions done in segregated suites Production in certified GMP suites
Document control and traceability No Yes Full traceability
QC and release Concentration, OD260/280,
RE digestion
Depending on individual project needs Full panel QC assays,
analytical development upon individual project needs
Aseptic fill/finish N/A Available upon request Yes
Storage of retention sample Available upon request Available upon request Yes
Document deliverable COA upon request 1. COA
2. Manufacturing summary
3. TSE/BSE statement upon request
1. COA
2. TSE/BSE statement
3. CTD documents
4. Others (BMR etc.) upon request

Workflow for GMP Production of Plasmid DNA

VectorBuilder strives to deliver products of good quality on time. Here is a typical GMP production workflow of plasmid DNA:

Vector characterization > Process development and cell banking > Plasmid production > Quality control and release.

Technology Platform

We can produce plasmids from up to 100 L fermentation system with a yield up to 5 g per batch. A general manufacturing process is shown below:

Cell Bank recovery and culture > Fermentation > Harvest and alkaline lysis > Centrifugation > Chromatography > TFF > Sterile filtration > QC

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.

Learn more about our analytical development
  • General/physical properties

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

  • Identity

    Restriction enzyme digestion, sequencing

  • Purity

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

    • Sterility: direct inoculation, membrane filtration sterility test
    • Endotoxin: kinetic chromogenic assay (KCA)

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.

Learn more about our cell banking and fill/finish services


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