GMP-like Plasmid DNA


PackGene’s GMP-like plasmid DNA manufacturing is a faster and more cost-effective alternative to full GMP production. Our GMP-like plasmids are high-quality plasmids produced following either standard or customizable specifications. GMP-Like plasmid DNA can be applied as an auxiliary or key raw material for protein or virus production in clinical trials.

Plasmid GMP-Like Product Features

Single-use fermentation (20L to 200L)

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Quality Inspection


Ultra-filtration & AKTA ready purification system

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Batch record, manufacturing summary report, CoA

Production Details

PackGene plasmid process GMP-Like
Clone screening
Growth condition optimization
High density fermentation
Alkaline lysis
Chromatographic purification
Antibiotics free
Consistent manufacturing process
Instrument calibration/validation Calibration

Manufacturing Facilities
Quality Control
Test Methods
Appearance Visual inspection
A260:280 Ultraviolet-visible spectrophotometry (A260/A280)
Homogeneity HPLC
Restriction Analysis Agarose gel
Residual RNA SYBRGold
Residual E. coli DNA qPCR
Endotoxin LAL
Bioburden Testing Direct inoculation
Sequencing Sanger
Antibiotics Free Production
Residual Host Protein HCP ELISA
Animal Free Production*
Mycoplasma Contamination qPCR
Material Archiving
pH Potentiometry

plasmid QC
Cell Bank Quality Control
Assay Method
Plasmid Yield Ultraviolet-visible spectrophotometry (A260)
Final Product Appearance Testing Plasmid Visual Testing
Host Cell Identity Bacterial Colony Morphology
Host Cell Identity Gram Stain Analysis
Physiological and Biochemical Detection IMViC test
Host Cell Purity LB Agar
Cell Bank Viability CFU/mL plate count analysis
Antibiotic Resistance CFU isolation on multiple antibiotic and antibiotic-free plates
Phage Contamination Plate bacterial cells on media containing no antibiotics
DNA Homogeneity Densitometry analysis of EtBr stained AGE
Identity EtBr stained agarose gel electrophoresis
Restriction Digest EtBr stained agarose gel electrophoresis
Plasmid Identity Double Stranded Primer Walking Sequencing.
Plasmid Retention Antibiotic Typing
Plasmid copy number Report
Contact Us
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Requesting a GMP-like Plasmid Project
5. GMP AAV Quote Request
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The information you submit here will be kept strictly confidential. Packgene will not disclose to any third party or related personnel, and it will only be used for project evaluation and progress reports according to the requests from submitter under confidentiality conditions.
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Are pH measurements required, and is a large amount of sample wasted to carry out pH measurements?

Measurement of pH is a mandatory for the release of rAAV Fast Service deliverables. A micro pH electrode may be used to save sample and thus the required sample volume to perform pH measurements is only ~15uL-100uL.

What is loading?

In accordance with the Pharmacopoeia General Rules 0942, we use the minimum filling quantity inspection method for detecting sample loading quantity.

How to interpret A260/A280 value?

A260/A280 is the ratio of sample absorbance measured at wavelengths of 260nm and 280nm. This measure is commonly thought to represent the ratio of DNA to protein in a sample. For rAAV, A260/A280 can used as a measure of the full to empty shell rate and to identify protein contamination. Low A260/A280 levels may suggest that the empty shell rate is high. Alternatively, high A260/A280 may suggest that the sample has been contaminated with proteins that are not incorporated into the AAV capsid shell. The greatest advantages of this measure are its convenience and speed.

What tests are performed to differentiate rAAV capsid proteins from specific protein impurities?

SDS-PAGE is used to identify rAAV capsid proteins. In addition, SDS-PAGE can be used to directly identify specific protein impurities including the presence of host proteins, BSA, or degraded AAV capsid proteins.

CDMO Plasmid Flyer

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