GMP-Like AAV for NHP Studies
Why Choose GMP-Like AAV for Your Upcoming NHP Study?
NHP studies are expensive, time-consuming, and critical to your program's success. Yet, relying on research-grade material for large animal studies introduces variables that often fail to translate to the clinic. This disconnect creates costly delays and technical risks when transferring processes to GMP suites.
Our GMP-like AAVs are manufactured with GMP platform processes and rigorously tested using GMP platform assays — giving you both premium-quality vectors for pivotal NHP studies and manufacturability data to de-risk your IND path.
GMP-like AAV Manufacturing Workflow for NHP Studies
Bridging the Gap: From Research to Clinic
Make the Switch with Confidence - Don't wait until GMP production to validate your manufacturing process. Switching to GMP-Like AAV for your pivotal NHP studies ensures your toxicity and efficacy data will translate to the clinic.
Ideal for:
- Pivotal NHP efficacy & safety studies
- Process lock-in & scale-up assessment
- Generating investor-grade data packages
Don’t risk your IND timeline with non-representative material. Secure your path to the clinic with GMP-like vectors.
Key Benefits
-
Purity & Safety
Maximize subject safety with endotoxin < 1 EU/mL and >80% full capsids, minimizing immune responses in NHP models. -
Process Insights
Manufacturability data: productivity, process yield, and product quality. -
Genome Integrity
Verified genome integrity: CE + Nanopore sequencing. -
Robust QC Assays
ddPCR titer, Mass Photometry, Endotoxin, Bioburden, and more... -
Investor-Ready Data
Generate pivotal data using the same platform processes (upstream/downstream) destined for your clinical run, ensuring your results are scalable and reproducible. -
GMP Transition
Seamless progression to GMP; reduced risk of tech transfer obstacles.
Service Details
| Grade of AAV Material | Research-Grade | GMP-Like (NHP) |
|---|---|---|
| Production Process | ROU-scale methods | Same protocols, materials, and equipment as GMP |
| Scale | 1E12-5E14 GC | 1E13-1E16 GC |
| Titer | qPCR | ddPCR |
| Genome Integrity | Optional | Capillary Electrophoresis (CE) + Nanopore Sequencing |
| Empty Capsids | Optional | <20% |
| Endotoxin | <10 EU/mL | <1 EU/mL |
| Residuals | - | Optional |
| Manufacturability Assessment | - | Optional |
| Turnaround | 17-25 days | 25-35 days |
For detailed information on PackGene’s comprehensive suite of AAV Testing Services, visit HERE.
Ready to de-risk your program?
Related Service
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AAV Production Services
- Fast, high-quality AAV vectors with reliably low empty capsid content
- 70+ serotypes, 40+ QC assays, and precision vector design expertise
- 50,000+ AAV batches delivered; effortless transition to GMP manufacturing
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AAV Packaging – Research Grade
- Delivery in as little as 12 days from miniprep to purified AAV virus.
- High purity, low endotoxin levels and minimal empty capsids for reliable performance.
- Access to 70+ serotypes and expert support, backed by 50,000+ successful projects.
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AAV Packaging – HT Grade
- Fast turnaround in as few as 7 business days
- Cost-effective with qPCR-based titer measurement
- Optimized for superior performance in cell culture
