AAV Neutralizing Antibody (NAb) Testing Solutions
Adeno-associated viruses (AAVs) are nonpathogenic viruses that are ubiquitous in nature. There are at least 13 naturally occurring serotypes of AAV, each differing in its ability to infect specific tissues or cell types (tropism). This property of tissue tropism enables engineered AAVs (vectors) to target gene delivery to particular cell types. Recently, the FDA has approved several gene therapies using AAV vectors for clinical use, with many more in development.
The development of AAV vector-based therapeutics, including research, translation, and preclinical studies, involves various animal models. Animals previously exposed to AAV (virus) that have developed an immune response as a result may carry AAV neutralizing antibodies (NAbs). These preexisting AAV NAbs can neutralize the AAV vector, hindering gene delivery to target cells. Therefore, screening animals for the presence of AAV NAbs can be crucial for success in translational studies for gene therapy candidates.
Charles River provides AAV NAb screening (qualitative) and titer (semi-quantitative) assays for multiple AAV serotypes (see Table 1), suitable for both large and small research models.
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Table 1: AAV Serotypes, Tropism, and Available Assays for AAV NAb Testing
Serotype and Tropism Assays Available Qualification Reports* AAV-1
CNS, retina, pancreas, skeletal muscle and heart• AAV1 NAb Screening
• AAV1 NAb TiterDownload Report AAV-2
CNS, kidney, photoreceptor cells, RPE (Retinal Pigment Epithelium)• AAV2 NAb Screening
• AAV2 NAb TiterDownload Report AAV-3B
Liver, cochlear inner hair cells• AAV3B NAb Screening
• AAV3B NAb TiterDownload Report AAV-5
CNS, lungs, photoreceptor cells, RPE (Retinal Pigment Epithelium• AAV5 NAb Screening
• AAV5 NAb TiterDownload Report AAV-6
Airway epithelia, skeletal muscle, cardiomyocytes, liver• AAV6 NAb Screening
• AAV6 NAb TiterDownload Report AAV-8
CNS, heart, liver, pancreas, photoreceptor cells, RPE (Retinal Pigment Epithelium), skeletal muscle• AAV8 NAb Screening
• AAV8 NAb TiterDownload Report AAV-9
CNS, heart, liver, lungs, skeletal muscle• AAV9 NAb Screening
• AAV9 NAb TiterDownload Report AAV-10
Intestinal and colon cells, hepatocytes, and lymph nodes• AAV10 NAb Screening
• AAV10 NAb TiterDownload Report AAV-rh.74
Skeletal muscle (including diaphragm) and cardiac muscle• AAVrh.74 NAb Screening
• AAVrh.74 NAb TiterDownload Report *Screening and titer assay qualification for each AAV serotype were performed using NHP serum samples, however assays are designed to effectively detect neutralizing antibody in serum for any other research model.
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Table 2: AAV NAb Assay Types
NAb screening assay
(+ or – at dilution of 1:10, 1:20, and 1:40)Qualitative assay at various dilutions to detect the presence of pre-existing neutralizing antibodies. NAb titer assay
(serum titration from 1:10-1:5,120)Quantitative assay to measure concentration or titer of antibody in serum.
Why Choose Our AAV Antibody Testing Services?
- Assays are optimized to detect the most frequently used AAV serotypes in therapeutic development
- Testing is species-independent and is available for both large and small research models
- Fast turnaround with results in just one to two weeks
- Assay transfer and custom project development support
- PCR-based detection of AAV (native virus) in serum and tissue is also available
An Easier Way to Submit Your Samples
Our Laboratory Testing Management® platform is a convenient solution for researchers looking to streamline their sample submissions, order tracking, and results reporting. Explore LTM™
Frequently Asked Questions (FAQs) About AAV-Neutralizing Antibody Testing
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What are the different assays available for testing of AAV neutralizing antibodies (NAb) in animal serum?
Screening (qualitative) and titer (semi-quantitative) assays are available for the detection of NAbs against a range of AAV serotypes. Refer to Table 1 for available assays.
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For which species are the AAV NAb testing assays available?
We accept samples from commonly used animal models in AAV-based gene therapy development. Please contact [email protected] if you have questions regarding test availability for your research model.
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How can I submit my samples to Charles River?
Laboratory Testing Management® (LTM™) allows you to generate sample submission forms electronically, order sample collection supplies, and schedule sample shipping. Orders received via LTM™ receive free shipping within the continental US (excluding live animals).
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What regulatory levels do you offer for AAV NAb assays?
AAV NAb screening and titer assays are non-GLP, research use only (RUO). Immunogenicity testing under GLP to detect neutralization activity is available through Charles River Bioanalytical Services.