Plasmid Non-GMP Manufacturing


PackGene provides flexible and reliable plasmid non-GMP production services ranging from 2L to 10L fermentation batches with downstream processing including ultrafiltration and chromatography. PackGene’s non-GMP plasmid products are widely applicable to early research, in vivo animal studies, and preclinical studies including pharmacodynamics and toxicology assessments.
CDMO service

Plasmid Non-GMP Product Features

Non-GMP bacteria bank generation

Glass Bioreactor from 2L to 10L

Ultra-filtration & AKTA Pure purification system

Plasmid process development

IND filing document preparation


Non-GMP Plasmid Manufacturing Workflow

Plasmid Quality Control (or customized based on specific process)

Category Items Method
General Characterization Appearance Visual inspection
pH pH meter
Identity Restriction Digest Agarose gel electrophoresis
Plasmid Sequence Sanger Sequencing
Content DNA Concentration UV spectrophotometry(A260)
Purity UV Purity A260/A280 ratio
DNA Homogeneity HPLC
Impurity Residual Host Cell DNA qPCR
Residual Host Cell RNA Agarose gel electrophoresis
Residual Host Cell Protein ELISA
Residual Kan ELISA
Safety Endotoxin LAL
Sterility Test Direct Inoculation Method

Our Advantages

High Productivity

Up to 10L scales bioreactor is capable of providing 0.5-1.5g of plasmid per batch.

Fast Turnaround

Plasmid production periods can be less than one month.

Cost Efficient

Our standardized and efficient processes allows us to provide competitive pricing.

Expert Team

PackGene has a professional plasmid production team including members with more than 10 years of experience.

Contact Us

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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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Related Services

Plasmids GMP Services

Multiple scales & grade of solutions of various kind of plasmids suitable for multiple treatments in a fast and cost effective way


AAV GMP Services

Ranging from small-scale AAV production, to large-scale AAV cGMP manufacturing for animal studies


Technology Platforms

PackGene’s proprietary π-Alpha™ 293 AAV High-yield Platform increases AAV production by 3 to 8 times that of traditional platforms.