In the development of life-changing adeno-associated virus (AAV) gene therapies, ensuring the safety and efficacy of these treatments can make the difference not only between success and failure, but also life and death.
At Svar Life Science, we work to develop and deliver solutions that can help support the development of innovative gene therapies, so that they can meet regulatory expectations and deliver optimal therapeutic outcomes.
Our unique AAV Immunogenicity Suite enables better-informed AAV immunogenicity assessment, supporting you in making confident safety decisions throughout your AAV program development that can better meet regulatory expectations.
Svar’s answer to the challenges of AAV gene therapies
AAV-mediated gene therapies are transforming medicine by offering new hope for patients with previously untreatable monogenic diseases. However, their widespread use is limited by immune responses to AAV vectors, which can cause serious and potentially life‑threatening toxicities and pose significant safety challenges.
Regulatory agencies are applying increasing scrutiny to the immunogenicity assessment of gene therapies and are calling for more robust solutions that deliver comprehensive characterization of immune responses to viral vectors.
Svar AAV Immunogenicity Suite stands out thanks to the first‑of‑its‑kind dedicated complement-activation assays designed for in vitro detection and quantification of pathway-independent AAV‑induced complement activation.
Once considered a minor and rare occurrence, AAV-induced complement activation is gaining recognition as a potential dose‑limiting toxicity in systemic AAV gene therapy, particularly at higher doses, where it is linked to severe adverse events (SAE), such as thrombotic microangiopathy (TMA).
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.
By providing targeted assessment of complement activation further to traditional NAb and TAb assessment, Svar equips you with tools that elevate your immunogenicity testing. The AAV Immunogenicity Suite enables a confident evaluation of immunological reactivity of your AAV therapeutic, supporting the establishment of safety assessment strategies to better meet regulatory expectations.
