GI Partners Acquires CDMO and Cell Solutions
As Rose BioSolutions, the established CDMO and Cell Solutions businesses continue to support the biotechnology ecosystem with cell sourcing capabilities and CDMO services to accelerate your advanced therapy from development to delivery.
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Explore AAV Packaging Plasmids for Any Stage You’re In
- Phase-appropriate AAV plasmids available in research, High Quality (HQ), and GMP grades
- Consistent and reliable production process, material, and personnel controls
- Kanamycin antibiotic resistance, compliant with current regulatory guidelines
- Animal component-free production, reduces contamination risk while supporting 3Rs initiatives
- License and royalty-free, from research to commercial
- Proven record of success in AAV production to support regulatory filings
Plasmid DNA from Concept to Cure
Exploring the challenges and considerations throughout CGT development, start with the end in mind, and download this resource to inform your critical starting materials strategy.
Access Guidebook
Research Grade, High Quality, and GMP AAV Rep/Cap Plasmids
| Quality Level | Product | Pack Size |
|---|---|---|
| Research Grade | RG-pAAV-REPCAP2-Kan | 2 mg 10 mg Custom inquiry |
| RG-pAAV-REPCAP5-Kan | ||
| RG-pAAV-REPCAP6-Kan | ||
| RG-pAAV-REPCAP8-Kan | ||
| RG-pAAV-REPCAP9-Kan | ||
| High Quality | HQ-pAAV-REPCAP2-Kan | 2 mg 10 mg Custom inquiry |
| HQ-pAAV-REPCAP5-Kan | ||
| HQ-pAAV-REPCAP6-Kan | ||
| HQ-pAAV-REPCAP8-Kan | ||
| HQ-pAAV-REPCAP9-Kan | ||
| GMP | GMP-pAAV-REPCAP2-KAN | 60 mg Custom inquiry |
| GMP-pAAV-REPCAP5-KAN | ||
| GMP-pAAV-REPCAP6-KAN | ||
| GMP-pAAV-REPCAP8-KAN | ||
| GMP-pAAV-REPCAP9-KAN |
Download the Research Grade AAV pHelper-Kan Plasmid User Manual
Research Grade, High Quality, and GMP AAV Helper Plasmids
| Quality Level | Product |
|---|---|
| Research Grade | RG-pAAV-HELPER-Kan |
| High Quality | HQ-pAAV-HELPER-KAN |
| GMP | GMP-pAAV-HELPER-KAN |
Download the HQ and GMP Grade AAV pHelper-Kan Plasmid User Manual
Pricing may be reflected as a custom request, based on current off-the-shelf stock availability and the amount of material requested.
“Gene therapy clients leveraging the Rep/Cap offering, combined with Charles River’s established CDMO capabilities and phase-appropriate approach, can expect reduced development costs, risks, and timelines while ensuring the highest quality product.”
Andrew Frazer, PhD, Associate Director, Scientific Solutions, Gene Therapy CDMO Services, Charles River
Production Process & Release Testing
| Assay | Method | HQ acceptance Criteria | GMP acceptance Criteria |
|---|---|---|---|
| Identity | Sequencing | Confirm full plasmid sequence | Confirm full plasmid sequence |
| Quantity – nucleic acid concentration | UV A260 | 2.0±0.2mg/mL | 2.0±0.2mg/mL |
| Identity by restriction digest | Restriction Digest | Plasmid identity confirmed | Plasmid identity confirmed |
| Total plasmid purity | Agarose Gel Electrophoresis | ≥95% | ≥95% |
| Supercoiled plasmid | Capillary Electrophoresis | ≥85% | ≥85% |
| Residual host cell RNA | RP-HPLC | ≤5% | ≤1% |
| Residual genomic DNA | qPCR | ≤5% | ≤2% |
| Residual host cell protein | ELISA | ≤2% | ≤1% |
| Residual Kanamycin | Colorimetric analysis | ≤5 ppm | ≤5 ppm |
| Bioburden | USP <61>, Ph. Eur. 2.6.12, 2.6.13 | ≤1 cfu/10mL | ≤1 cfu/10mL |
| Sterility* | USP <1071> | No growth | No growth |
| Mycoplasma* | PCR EP/USP | Negative | Negative |
| Endotoxin | USP <85>, Ph. Eur. 2.6.14 | ≤10 EU/mg | ≤10 EU/mg |
| Appearance | Visual inspection | Clear, colorless solution free from visible particulate matter | Clear, colorless solution free from visible particulate matter |
| pH | USP <791>, Ph. Eur. 2.2.3 | 8.0 ± 0.5 | 8.0 ± 0.5 |
| 260/280 ratio | UV spectrophotometry | 1.8-2.0 | 1.8-2.0 |
*Sterility and Mycoplasma testing are not performed for R&D grade plasmid.
Additional Resources
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pHelper-Kan Plasmid Map
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pRep/Cap Plasmid Maps
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Efficient AAV Packaging of Different Serotypes
The robust virus packaging productivity of the pHelper-Kan plasmid has been tested in almost all AAV serotypes. pHelper-Kan is being used in our daily AAV production, for both CGMP grade and research grade batches. Please see the production data below for AAV2, AAV5, AAV6, AAV8, and AAV9 serotypes.
pHelper-Kan was used in AAV production in adherent HEK293 cells. pHelper-Kan was cotransfected with the AAV transfer vector and pRepCap into HEK293 cells for AAV packaging. The productivity data for each AAV serotype is from 10 individual productions with different AAV transfer vectors containing unique genes of interest. The viral genome titers were measured using qPCR with primers targeting the ITRs.
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AAV Production Using Triple Plasmid Transfection Method
AAV virus production using triple plasmid transient transfection method. AAV viral vectors are then packaged and assembled when the AAV transfer vector, pHelper, and pRepCap are cotransfected into HEK293 cells. The AAV transfer vector contains the gene of interest, pHelper plasmid provides Ad helper function genes, and pRepCap encodes AAV Rep and Cap.
Need Custom Plasmid Production?
With plasmid DNA also manufactured on request, if you do not see the AAV plasmid product you require, our CDMO team offers a comprehensive range of solutions for applications ranging from preclinical research studies to clinical trials and commercial scale.
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