GMP Plasmid Manufacturing

Start your project immediately!

Accumulated experience in GMP manufacturing

Drawing on accumulated manufacturing experience, strategic cost effectiveness, and strict compliance standards, GenScript ProBio is providing GMP plasmid DNA from US facility to clients.

The manufacturing of GMP plasmid is performed in segregated manufacturing suites in USA GMP facility, and they can be used as drug substance or drug product for all stage of clinical trials and commercial supply.

GenScript ProBio is ready to start your project immediately, and shorten the lead time employing our extensive know-how in the complexity of pDNA manufacturing.

Expect MORE from GMP Plasmid

• 

  Ready to start RIGHT NOW

  No long waiting
  Shorten TAT using cutting-edge technologies

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  Experts in GMP plasmid

  Experience with over 10 DNA vaccines
  Underwent over 10 GMP inspections

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  Quality driven service

  One-to-to project management
  Ensuring safety and adherence to guidelines

Quality Control Information

More assays are included except for the ones listed below, and other options are available. Get a quote for more information.

Cell bank Assays

Identity and Purity	Presence of Plasmid	Adventitious Agents
Viability Bacterial Strain Characterization Genotyping/Phenotyping	Sequence of Plasmid DNA Number of Copies Restriction Map Percentage of Cells Retaining Plasmid	Purity by Plating Presence of Bacteriophage

Product quality control and Release

Assay	Method
Appearance	Visual
Identity	Restriction Digest/Agarose Gel Electrophoresis Analysis
Total Nucleic Acid Concentration	UV Spectrophotometry
pDNA % Supercoiled form	HPLC
Residual Host Genomic DNA	qPCR
Residual RNA Content	Agarose Gel Electrophoresis Analysis
Residual Protein Content	BCA
Residual Kanamycin	Delvotest
Endotoxin	USP <85>
Bioburden	USP <61>
pH	USP <791>

*More options available. Get a quote and know more.

Start your project right now!

Related Products

• ProPlasmid™ Manufacturing
• GMPro™ Plasmid Manufacturing
• Viral vector services

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