GMP Plasmid Manufacturing Service

Yes. uBriGene provides plasmid DNA manufacturing for research and development through GMP applications, with production options matched to the development stage and intended use. Research-grade and GMP plasmid DNA can be manufactured according to program requirements.

GMP plasmid manufacturing can take approximately two to three months before QC testing when starting with microbial Master Cell Bank development. The timeline can vary with plasmid construct, cell-bank development, process development, manufacturing scale, and analytical requirements. Qualified, in-stock plasmids may have shorter lead times.

Yes. uBriGene's GMP plasmid manufacturing platform supports development through clinical-scale production, with upstream manufacturing capacity of up to 200 L. Scale-up is evaluated according to the plasmid construct, microbial cell bank, fermentation conditions, downstream process, and final product specifications.

uBriGene has manufactured more than 300 GMP plasmid batches, supporting plasmid programs from development through GMP manufacturing.

uBriGene manufactures multiple DNA formats, including circular plasmids, single-stranded DNA, linear DNA, linear closed-end DNA, and minicircle DNA. Linear DNA can be used as a template for mRNA production, while linear closed-end DNA can support applications such as gene-editing donor templates. The appropriate format depends on the intended application, construct design, and manufacturing requirements.

uBriGene's GMP plasmid manufacturing process includes qualified E. coli strains and microbial cell banking, upstream cultivation, closed alkaline lysis, depth filtration, and downstream purification using anion-exchange and hydrophobic-interaction chromatography. Larger-scale production can also incorporate membrane chromatography.

uBriGene's GMP plasmid QC panel includes appearance, pH, concentration, identity, target-sequence analysis, purity, supercoiled plasmid ratio, residual E. coli DNA, RNA and protein, endotoxin, and sterility. Additional testing can be established according to the plasmid construct, intended application, and regulatory requirements.

Yes. uBriGene provides custom plasmid manufacturing with support for technology transfer, process development, and analytical method development according to the plasmid construct and program requirements.

uBriGene's GMP plasmid platform reports greater than 90% supercoiled plasmid DNA under reported process conditions. Supercoiled content is assessed as part of plasmid QC because plasmid topology is an important quality attribute for applications such as viral-vector and RNA manufacturing. Final release specifications are established for the specific plasmid product and intended application.

GMP plasmid manufacturing cost depends on factors such as plasmid type and size, production scale, microbial cell-bank requirements, process development, purification strategy, analytical testing, and final product specifications. Custom development or additional testing can also affect the overall cost. Pricing is established according to the specific manufacturing and testing scope.

Research-grade plasmid DNA is generally intended for research and development applications, while GMP plasmid DNA is manufactured and controlled under GMP quality systems for regulated or clinical manufacturing applications. The two grades can differ in manufacturing controls, documentation, characterization, release testing, and intended use.

GMP plasmid programs can include Certificates of Analysis, manufacturing and batch documentation, QC and release-testing results, and applicable regulatory-support documentation. The documentation package depends on the plasmid, manufacturing stage, intended application, and requirements of the applicable regulatory submission.

GMP plasmid batch output depends on the plasmid construct, fermentation scale, process conditions, and downstream recovery. uBriGene's platform supports upstream production up to 200 L and reports productivity of up to 1 g/L under applicable process conditions, with approximately 60% downstream recovery reported under certain conditions. Actual batch output is established for the specific plasmid and manufacturing process.

Yes. GMP plasmids can be used as production materials for viral-vector manufacturing, including AAV and lentiviral vector (LVV) production, when their design, quality attributes, and manufacturing controls are appropriate for the specific process. uBriGene also provides GMP AAV and LVV packaging plasmids with applicable regulatory documentation.