New AAV9-induced Complement Activation Assay
Elevate your AAV immunogenicity testing with Svar’s unique complement system expertise
Leveraging Svar Life Science’s know-how in the complement system, we are proud to introduce the new AAV9-induced Complement Activation ELISA for gene therapy immunogenicity studies, the newest addition to our research use only AAV Immunogenicity Suite. This is the first and only commercially available kit designed for the semi-quantitative detection of AAV9-induced complement activation in the development of gene therapies based on the use of adeno-associated viral vectors (AAV).
This unique immunogenicity solution provides you with a critical advantage in the assessment of immune reactions to the AAV9 serotype, helping mitigate risks that could compromise capsid development and undermine therapeutic success.
Growing evidence highlights the role of the complement system in severe and potentially life-threatening immune-mediated reactions to AAV-based gene therapies, including serious adverse events (SAE), such as hepatotoxicity and thrombotic microangiopathy (TMA).
Researchers at the forefront of gene therapy development require robust, fit‑for‑purpose tools to accurately characterize AAV‑induced complement activation, to ensure patient safety and treatment’s efficacy.
The AAV9‑Induced Complement Activation assay meets the critical need for a dedicated, reliable solution to detect AAV‑induced complement activation in samples upon exposure to AAV9 capsids. This assay strengthens the immunogenicity characterization of your AAV therapy, supporting a proactive safety strategy and helping ensure readiness for evolving regulatory expectations.
This new on-demand assay builds on Svar’s AAV immunogenicity offering of fully customizable AAV-complement activation ELISA assays with a kit tailored to AAV9, one of the most used capsids in gene therapy development.
The new AAV9-induced Complement Activation ELISA offers:
- Functional evaluation and characterization of antibody-mediated and pathway-independent complement activation induced by adeno-associated viral vectors of serotype 9 (AAV9) in vitro.
- Expanded safety assessment profile of AAV gene therapy candidates, including the characterization of AAV-mediated complement activation.
- Characterization of potential complement-related adverse events and their variability across individuals.
- High sensitivity even at low antibody titers, reflecting real-world patient variability.
- Prediction of complement-driven response in individual samples, independent of TAb titers, which could otherwise be overlooked in standard immunogenicity assessment.
- Clear characterization of subject-to-subject variations in complement responses following AAV exposure in early-stage research.
- Key insights on complement-related severe adverse events (SAE) that could inform clinical trial approaches to help ensure drug safety and efficacy.
Elevate your AAV immunogenicity testing
The AAV9-induced Complement Activation assay is a first-of-its-kind solution designed to support AAV-mediated gene therapies development by specifically evaluating complement activation independent of the complement pathway (classical, lectin, and alternative) and sample-to-sample variability in a human-serum functional assay.
Other available immunogenicity assays do not directly interrogate functional complement activation caused by AAV exposure, failing to characterize this important element of immune reactions in response to AAV vectors.
Tailored to AAV9, customizable to any AAV capsid – get in touch!
The AAV9-induced Complement Activation Assay strengthens the Svar AAV Immunogenicity Suite, adding an on-demand solution alongside our fully customizable AAV complement activation ELISAs, AAV Neutralizing Antibody (NAb) Reporter Gene Assays, and AAV Total Antibody (TAb) custom assays.
Through Svar CRO Services’ extensive expertise, we can develop dedicated assays optimized for characterizing immune reactions to any AAV capsid, ensuring you can access the full immunogenicity profile of your therapy, no matter what AAV capsid you choose.
Interested in requesting a custom AAV Complement, NAb, or TAb assays? Get in touch with us today.
Svar's AAV Immunogenicity Suite
Total Anti-AAV
Antibody Assays
TAb
Tailored ELISA-based Total Antibody assays to assess pre-existing or induced antibody-mediated immunity towards different AAV serotypes.
- Available as a custom solution.
Neutralizing
Antibody Assays
NAb
Cell-based assays for evaluating the functional impact of antibodies on vector transduction efficiency.
- Available as a custom solution.
- Ready to order assays for AAV serotypes 2, 5, 6, 8, and 9.
Complement
Activation
Custom Assays
ELISA-based assays for the detection of AAV-induced complement activation in AAV-mediated gene therapies.
- Available as a custom solution.
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