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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
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 and data were normalized to the titer of the RUO system.
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 |
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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 |
Figure 3. Viral Production Cells 2.0 maintain similar growth profiles over multiple passages. Cells were cultured in Viral Production Medium, and culture viability and VCD were measured from day 4 to day 7 post-seeding.
Figure 4. CTS Viral Production Medium supports the high density and robust growth of VPCs 2.0 for 7 days without additional nutrient support in multiple scales of cell culture. VPC2.0 were started in culture at 0.5 x 106 cells/mL in each size of culture and measure the growth for 7 days with Vi-Cell XR. All shake flasks used were Nalgene (Thermo Fisher Scientific) with the exception of the 5 L shake flask, which is a product of Corning.
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.
Figure 7. Comparison of lysis using the AAV-MAX Lysis Buffer to other methods. AAV2 and AAV6 were produced using the AAV-MAX system. Samples were lysed using the AAV-MAX Lysis Buffer, Triton X-100, or a freeze/thaw procedure. Titers were measured using qPCR, and data were normalized to the titer (vg/mL) of the AAV-MAX Lysis Buffer sample.
Figure 3. Viral Production Cells 2.0 maintain similar growth profiles over multiple passages. Cells were cultured in Viral Production Medium, and culture viability and VCD were measured from day 4 to day 7 post-seeding.
Figure 4. CTS Viral Production Medium supports the high density and robust growth of VPCs 2.0 for 7 days without additional nutrient support in multiple scales of cell culture. VPC2.0 were started in culture at 0.5 x 106 cells/mL in each size of culture and measure the growth for 7 days with Vi-Cell XR. All shake flasks used were Nalgene (Thermo Fisher Scientific) with the exception of the 5 L shake flask, which is a product of Corning.
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.
Figure 7. Comparison of lysis using the AAV-MAX Lysis Buffer to other methods. AAV2 and AAV6 were produced using the AAV-MAX system. Samples were lysed using the AAV-MAX Lysis Buffer, Triton X-100, or a freeze/thaw procedure. Titers were measured using qPCR, and data were normalized to the titer (vg/mL) of the AAV-MAX Lysis Buffer sample.
Figure 8. High titers are achieved at a 1,000 L scale in a single use bioreactor. AAV6-GFP was produced using the AAV-MAX system at a 1,000 L production scale in a 5,000 L Thermo Scientific DynaDrive Single-Use Bioreactor (S.U.B.) and compared to shake flask controls. Titers were measured in crude samples with ddPCR.
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.