Custom AAV Immunogenicity Assay Development

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

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
Svar AAV Trifecta - Square