Plasmid Production Platform


Plasmids are widely used across multiple therapeutic modalities including applications in Gene and Cell Therapies (GCT), mRNA/DNA Vaccines, and nucleic acid drugs. PackGene provides a one-stop solution for GMP plasmid projects including bacteria banking, process development, analytical methodology development, plasmid manufacturing, plasmid stability testing, and document preparation.

GMP Plasmid Prep Production Process and Timeline
Track Records

11 IND projects: 4 Pre-IND, 2 on-going IND filing, 1 IND FDA approval
9 IIT projects: 3 Pilot studies, 3 IIT studies

Quality Management System
Facility GMP lab
PW、WFI、PS system
Instrument calibration/validation
Environmental monitoring
Raw Material Vendor qualification
Raw material testing requirements
Supply source traceability
Vendor CoA
CMA(Critical material attributes) assessment
Production Production bacteria banking
Antibiotics free
High density fermentation
Alkaline Lysis
Chromatography purification
Documentation TSE/BSE
Production report
Good documentation practice
QA Staff training
Validated change control
Test in GMP QC lab
Quality agreement
 QA oversight
Process and Method Process Development and Validation
Method Validation
Specification Specification Established

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plasmid QC

PackGene is a world-leading plasmid manufacturer with state-of-the-art facilities designed to meet the highest standards of GMP production. Spanning 1,300 square feet, our PD room serves as the innovation hub for cutting-edge research and development.

Our impressive 11,000 square feet GMP room houses advanced equipment, including 5L to 200L fermenters that enable us to handle diverse batch sizes of up to approximately 100g. With a remarkable capacity to produce over 1000g of GMP grade plasmid DNA per year, we meet the demands of even the most ambitious projects. Our success is underpinned by a dedicated team with extensive expertise. The plasmid prep team of approximately 40 staff members holds decades worth of combined experience in AAV plasmid preparation. With such a large and experienced team we are able to ensure seamless and uninterrupted production with teams taking shifts to maintain round-the-clock operations. At PackGene, we are committed to delivering top-quality plasmids to advance research and drive innovation in the biotechnology industry.

Robust Platform

Scalability: Our efforts to optimize the plasmid prep process have resulted in increased efficiency and scalability that drive consistent batch to batch yields with regard to both fermentation and purification recovery rates.

Batch-to-batch consistency: The examples below demonstrate our fermentation yield consistency across three separate fermentation rounds using the same AAV cis plasmid template in a 50L fermenter.

Specialized Platform for High-yield Plasmid AAV Production

PackGene’s proprietary π-Omega Plasmid DNA High-yield Platform increases plasmid yield by more than 3 times through plasmid backbone optimizations. Production scales can reach up to 200L, and single-batch production yields can reach up to 100 grams. As a key raw material in AAV production, reducing the cost of plasmid DNA greatly reduces AAV production cost while simultaneously meeting the growing demand of plasmids for use in the production of mRNA-based therapeutics.

Advantages of Our One-stop Plasmid Preparation Solution


Two independent cGMP production lines with up to 200L production scale.

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Isolated production lines, rigorous cleaning methods, and the use of disposable materials completely avoid cross-contamination.



Multiple scales and grades of production make it possible to complete your project with high efficacy at a reasonable price.



PackGene’s expert production team has more than 10 years of experience in plasmid manufacturing.


Advanced equipment

Single-use technology applied in both upstream & downstream processes. Fill & Finish under VHP isolator.

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.