CTS AAV-MAX Helper Free AAV Production System
Accelerate the path to clinic with complementary research and cGMP-manufactured AAV-MAX solutions. One complete AAV production system for facilitating a seamless translation from research to clinical and commercial production.
Research & Development → Preclinical → Clinical and commercial production
Comparison of RUO and CTS AAV-MAX production systems
The AAV-MAX Helper-Free AAV Production System enables a smooth transition from discovery through research and commercial development manufacturing, offering one optimized, scalable platform with research-grade and cGMP-manufactured reagent options. Figure 2 shows the equivalence of the CTS and RUO systems with two serotypes.
Figure 2. Comparison of AAV titers between research-grade (RUO) and CTS reagents. AAV serotypes AAV2 and AAV6 were produced at 30 mL production scale in 125 mL shake flasks. Performance of the RUO and CTS AAV-MAX system reagents was shown to be equivalent as measured by viral titers. Titers were measured by qPCR.
Attributes | AAV-MAX (RUO) | CTS AAV-MAX |
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Intended use | For research only | For research use or manufacturing of cell, gene, or tissue-based products |
Catalog pack sizes | 1-10 L production scale | 1–100 L production scale |
Formulation | Same (medium requires GlutaMAX supplementation) | Same (medium contains GlutaMAX) |
Performance | Same | Same |
Producer cell line |
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Regulatory support documentation | None |
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GMP manufacturing | Manufactured at ISO 90001 or ISO 13485 certified sites | Manufactured in conformance with GMP for medical devices, 21 CFR Part 820, USP<1043>, and Ph Eur 5.2.12. Manufactured at sites that are ISO 13485-certified |
Components of the CTS AAV-MAX Helper Free AAV Production System
CTS Viral Production Cells (VPCs) 2.0
- Clonal, 293F-derived, high-producing cell line
- Optimized for high-density suspension culture (>12 x 106 cells/mL) in a chemically defined medium
- No SV40 large T antigen or genetic engineering
- Robust scalability and passage stability
- Documented, cGMP bank–manufactured as per 21 CFR 211 and EudraLex, Volume 4, and characterized as per ICH Q5A and ICH Q5D guidelines
Medium
- CTS Viral Production Medium
- Animal origin–free
- Chemically defined
- Protein-free
- Phenol-red free
- Available off-the-shelf in pack sizes up to 100 L
- Advanced Granulation Technology (AGT) formats
- Granular dry media format
- Animal origin–free
- Chemically defined
- Protein-free
- Phenol-red free
- Available off-the-shelf in pack sizes up to 100 L
- AGT granules dissolve rapidly and are pre-adjusted for pH and osmolality
Transfection and production
- CTS AAV-MAX Transfection Reagent and Transfection Booster (AOF, CD)
- CTS AAV-MAX Enhancer (AOF, CD)
- CTS Viral-Plex™ Complexation Buffer (AOF, CD, protein-free)
Figure 5. Results of AAV production with and without added Enhancer. The Enhancer was added to prepared VPCs 2.0 with 3 x 106 cells/mL on the day of transfection (T=0). For transfection, a GFP-expressing transfer plasmid and helper plasmid were used with respective Rep/Cap plasmids. 72 hours post transfection, AAV-MAX Lysis buffer was added to the culture directly to harvest AAV for 2 hours at 37°C, followed by AAV titer measurement by qPCR. The data were normalized to the titer (vg/mL) of AAV production with Enhancer.
Figure 6. Results of AAV production with and without added Booster during transfection. For transfection, a GFP-expressing transfer plasmid and a helper plasmid were used with respective Rep/Cap plasmids. 72 hours post transfection, AAV-MAX Lysis buffer was added to cultures directly to harvest AAV for 2 hours at 37C then followed by AAV titer measurement by qPCR. The data was normalized to the titer (vg/mL) of AAV production with Booster.
CTS Viral Production Cells (VPCs) 2.0
- Clonal, 293F-derived, high-producing cell line
- Optimized for high-density suspension culture (>12 x 106 cells/mL) in a chemically defined medium
- No SV40 large T antigen or genetic engineering
- Robust scalability and passage stability
- Documented, cGMP bank–manufactured as per 21 CFR 211 and EudraLex, Volume 4, and characterized as per ICH Q5A and ICH Q5D guidelines
Medium
- CTS Viral Production Medium
- Animal origin–free
- Chemically defined
- Protein-free
- Phenol-red free
- Available off-the-shelf in pack sizes up to 100 L
- Advanced Granulation Technology (AGT) formats
- Granular dry media format
- Animal origin–free
- Chemically defined
- Protein-free
- Phenol-red free
- Available off-the-shelf in pack sizes up to 100 L
- AGT granules dissolve rapidly and are pre-adjusted for pH and osmolality
Transfection and production
- CTS AAV-MAX Transfection Reagent and Transfection Booster (AOF, CD)
- CTS AAV-MAX Enhancer (AOF, CD)
- CTS Viral-Plex™ Complexation Buffer (AOF, CD, protein-free)
Figure 5. Results of AAV production with and without added Enhancer. The Enhancer was added to prepared VPCs 2.0 with 3 x 106 cells/mL on the day of transfection (T=0). For transfection, a GFP-expressing transfer plasmid and helper plasmid were used with respective Rep/Cap plasmids. 72 hours post transfection, AAV-MAX Lysis buffer was added to the culture directly to harvest AAV for 2 hours at 37°C, followed by AAV titer measurement by qPCR. The data were normalized to the titer (vg/mL) of AAV production with Enhancer.
Figure 6. Results of AAV production with and without added Booster during transfection. For transfection, a GFP-expressing transfer plasmid and a helper plasmid were used with respective Rep/Cap plasmids. 72 hours post transfection, AAV-MAX Lysis buffer was added to cultures directly to harvest AAV for 2 hours at 37C then followed by AAV titer measurement by qPCR. The data was normalized to the titer (vg/mL) of AAV production with Booster.
Scaling the CTS AAV-MAX System
Cell Therapy Systems (CTS) reagents for AAV-MAX production workflows
Gibco Cell Therapy Systems (CTS) reagents are GMP-manufactured products designed for cell and gene therapy, so you can transition your therapy to the clinic with confidence.
cGMP manufacturing | Testing and documentation | Proven use |
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Manufactured in conformance with GMP for medical devices, 21 CFR Part 820, USP<1043>, and Ph Eur 5.2.12.Manufacturing sites are FDA-registered, ISO 13485–certified, and regularly audited. | Traceability documentation—including Drug Master Files (DMFs) and/or Regulatory Support Files (RSFs), Certificates of Origin (CoOs). Product safety testing—including sterility, endotoxin, and mycoplasmas on applicable products. | Used in FDA-approved and EMA-approved CAR T therapies and the first FDA-approved therapeutic cancer vaccine. [1] Used in over 100 clinical trials. |
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Intended use of the products mentioned on this page vary. For specific intended use statements please refer to the product label.