At Svar Life Science, we deliver solutions designed to support the safety of innovative therapies and enable optimal therapeutic outcomes.
Svar’s unique AAV Immunogenicity Suite offers a holistic answer to risk assessment requirements of AAV-mediated gene therapies, enabling an expanded immunogenic characterization of therapeutic candidates.
AAV-mediated gene therapies are revolutionizing medicine, offering renewed hope to people living with previously untreatable monogenic diseases. Despite their immense potential, the application of AAV-mediated gene therapies is still limited by the immune response to the AAV vectors that can result in serious and even life-threatening immune-related toxicities, posing serious safety challenges.
Adding to this, growing evidence highlights the role of the complement system in severe and potentially life-threatening immune-mediated responses to AAV-based gene therapies, such as thrombotic microangiopathy (TMA). AAV-induced complement activation is gaining recognition as a potential dose-limiting toxicity in systemic AAV gene therapy.
Concerns with AAV-therapies’ safety challenges are reflected in how agencies are applying increasing scrutiny to their immunogenicity assessment, calling for more robust solutions that deliver comprehensive characterization of immune responses to viral vectors.
Researchers at the forefront of gene therapy development require robust, fit‑for‑purpose tools for accurate characterization of AAV-induced complement activation that can help meet current and future regulatory demands.
Svar’s unique AAV Complement Activation solutions, now including the AAV9-induced Complement Activation Assay, enable more extensive AAV immunogenicity assessment of the therapeutic, offering potential to better meet present and future regulatory expectations.
With tailored NAb, TAb, and complement-activation assays, Svar AAV Immunogenicity Suite elevates your immunogenicity testing, enabling a confident evaluation of immunological reactions to AAV therapies that better inform the risk assessment in the development process of AAV-mediated gene therapies.
Learn more about Svar’s complete AAV Immunogenicity Suite
Full customization to meet your development demands
Through Svar CRO Services’ extensive expertise, we offer fully customized development of dedicated assays for the characterization of in vitro, AAV-induced, immune reactions.
With extensive customization options, you can access a fuller immunogenicity profile to better understand your therapeutic, no matter what AAV capsid you choose.
Interested in requesting a custom AAV Complement kit? Get in touch with us today.
