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.
| QMS |
| Facility | GMP lab |
| PW、WFI、PS system | |
| Instrument calibration/validation | |
| Environmental monitoring | |
| Maintenance | |
| Raw Material | Vendor qualification |
| Raw material testing requirements | |
| Animal-free | |
| 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 |
| COA & COC | |
| 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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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.
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.
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.
Productivity
Two independent cGMP production lines with up to 200L production scale.
Quality
Isolated production lines, rigorous cleaning methods, and the use of disposable materials completely avoid cross-contamination.
Flexibility
Multiple scales and grades of production make it possible to complete your project with high efficacy at a reasonable price.
Professional
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.
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.
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