AAV Plasmid Manufacturing
AAV Plasmid Manufacturing
Our plasmid platform provides high-quality plasmids to support a wide range of gene therapy applications. Using advanced manufacturing technologies, we ensure high purity, batch-to-batch consistency, and reliable performance across all products.
Rigorous quality control procedures are implemented at every stage of manufacturing to maintain the highest standards. Each product is accompanied by comprehensive documentation to support research, development, and regulatory requirements.
Trusted by leading gene therapy researchers and pharmaceutical companies worldwide, our plasmid platform enables the development of innovative gene therapies. Through high-quality plasmid products and dedicated technical support, we are committed to advancing gene therapy research and improving patient outcomes.
Plasmid Analysis Methods and Specifications
PEIone demonstrates superior transfection efficiency at lower reagent-to-DNA ratios compared to conventional PEI reagents, reducing costs and minimizing cytotoxicity.
| No. | Assay | Method | Specification | Industrial Grade | GMP Grade |
|---|---|---|---|---|---|
| 01 | Appearance | Visual Inspection | Clear and Colorless Solution | √ | √ |
| 02 | Concentration | Ultraviolet Spectroscopy (UV) | 1.0±0.2 mg/mL | √ | √ |
| 03 | pH | USP<791> | 6.5–8.5 | √ | √ |
| 04 | Identity | Restriction Map | Identical to Theoretical or Identical to Reference Map | √ | √ |
| 05 | Purity A260/A280 | Ultraviolet Spectroscopy (UV) | 1.8–2.0 | √ | √ |
| 06 | % Supercoiled | HPLC | ≥85% | √ | √ |
| 07 | Residual Host Protein | ELISA | ≤0.5% | √ | √ |
| 08 | Residual Host Genomic DNA | qPCR | ≤0.5% | √ | √ |
| 09 | Residual Host RNA | RT-qPCR | ≤0.5% | √ | √ |
| 10 | Bacterial Endotoxin | USP<85> | <10EU/mg | √ | √ |
| 11 | Sterility | USP<71> | No Growth | – | √ |
| 12 | Sequence Identity | Sequencing | Identical to Theoretical Sequence | – | √ |
Off-the-shelf pHelper Plasmid
AAVnerGene currently provides a selection of proprietary off-the-shelf pHelper plasmid for AAV production. The AAV pHelper plasmids are available in both industrial grade and GMP grade, allowing us to better meet the diverse requirements of our clients.
| Product Name | Product Description | Catalog No. | List Price (USD) | Resistance Gene |
| pHelper plasmid | – Industrial Grade | SM000002-1mg | 599 | Kanamycin |
| SM000002-10mg | 999 | |||
| SM000002-100mg | 5999 | |||
| – GMP Grade | SM000003-1mg | 19999 | ||
| SM000003-10mg | 89999 | |||
| SM000003-100mg | 159900 |
Customized AAV Plasmid Production
| Product Type | Guaranteed Amount | Each Lot (1st time) | Subsequent Each Lot |
Industrial Grade | >1g | $24,999 | $19,999 |
| >2g | $31,999 | $24,999 | |
| GMP Grade | >1g | $119,999 | $99,999 |
| >2g | $159,999 | $119,999 | |
| >5g | $279,999 | $219,999 |