Tailored Safety Solutions for Gene Therapy
As gene therapy continues to evolve, the demand for precise and reliable immunogenicity assessment—particularly with adeno-associated virus (AAV) vectors—has never been greater. Our tailored safety solutions for gene therapy are designed to address this challenge head-on.
These assays are available as part of our CRO services, where we offer customized work orders that includes:
- Custom assay development using either wild-type (WT) or client-specific AAV vectors
- Method development and validation tailored to your regulatory and clinical context
- Sample analysis services for preclinical and clinical studies
Our comprehensive suite of AAV-related immunogenicity assays
- Total anti-AAV antibody assays to detect pre-existing or induced antibodies against the AAV capsid.
- Neutralizing antibody (NAb) assays to evaluate the functional impact of antibodies on vector transduction efficiency.
- Complement activation assays to assess the risk of immune-mediated adverse events triggered by AAV-antibody interactions.
Each assay can be developed as a standalone solution or integrated into a complete safety assessment package, depending on your project’s needs. Our approach is rooted in flexibility and scientific rigor—because no AAV vector is the same, and neither are your development goals.
With our deep expertise and agile infrastructure, we specialize in tailoring assays to your specific vector serotype, capsid modifications, and context. Whether you're in early discovery or late-stage development, we provide innovative, reliable, and regulatory-aligned solutions to support your gene therapy pipeline.
Our offering:
Customizable AAV Assay Platforms for Immune Safety Assessment
AAV Nab Assay Platform
Customization for Any Capsid
The flexibility and adaptability of iLite technology in this platform means that our AAV-packaging cells can be easily adapted to produce any vector of choice. The effector cells remain the working horse and combine with your unique packaging cell line, producing your unique vector - this system gives a truly AAV vector-specific set up ideal for the assessment of recombinant next-gen vectors and their transduction efficacy, offering solutions for hybrid, chimeric, or semi-synthetic capsids.
AAV TAb Assay platform
Assess pre-existing total antibodies towards any capsid of choice
The flexibility and robustness of our ELISA-based total antibody assays make them ideally suited for detecting immune responses against any AAV vector. These assays can be readily customized to support the evaluation of both conventional and next-generation AAV constructs, including hybrid, chimeric, and engineered capsids, offering a versatile and scalable solution for advancing gene therapy research.
AAV Complement Assay Platform
Unique assays to assess AAV-mediated complement activation
These ELISAs offer a proactive approach to identifying complement activation risks, helping to enhance patient safety.
With serotype-specific sensitivity, this assay helps you gain clearer insight into immune risk, before the therapeutic reaches the clinic. Tailoring assessment to individual AAV serotypes allows for more informed decisions around vector and patient selection, supporting safer, more confident progress in gene therapy development.
Schedule a Consultation Now and Take the Next Step in Advancing Your Gene Therapy Program
Partner with Svar to confidently optimize your unique AAV vector. With deep expertise in immunoassays, cell-based assays, and immunogenicity assessments across diverse pharmaceutical settings, we provide the tools and insights you need to overcome complex development challenges.
Let’s shape the future of Gene Therapy—together.
Contact us to get started