Some biotherapies such as immunization are aimed at getting the immune system activated, while others, such as gene therapy, seek to prevent it from being triggered. In all cases, it is crucial to evaluate and characterize the immune response.

From preclinical steps to clinical phases, GenoSafe provides custom assays to support the follow up of immune responses in animal models and in patients enrolled in clinical trials:

Measure of cytokines, chemokines and growth factors

Today, we have techniques to quantify soluble cytokines and other analytes in biological samples and cell culture supernatants which are rapid, precise, and cost-effective.

Depending on the characteristics and parameters of your project, we take in charge your study with one of the two technical approaches:

  • Commercially available Enzyme Linked ImmunoSorbent Assays (ELISA) kits
  • Multiplex bead array assays that provide quantitative measurement of large numbers of analytes in a small volume using an automated 96-well plate format (BioPlex 200 System Utilizing xMAP technology licensed from Luminex®)

Detection of circulating antibodies

Measuring antibody production in response to antigen exposure is essential to assess the humoral immune response. The method is based on specific binding between an antigen and the antibodies present in the plasma / serum to determine a “titer” of antigen-specific antibodies.

We propose custom solutions to answer your needs, mostly based on Enzyme-linked immunosorbent assay (ELISA), the most commonly used method to perform this type of assessment.

Measure of anti-virus/vector neutralizing factors

The neutralizing factors / antibodies block the entry of viruses into the cells. This phenomenon is sought in a vaccination approach whereas it is undesirable in the case of a gene therapy using a viral vector.

GenoSafe provides virus/vector neutralization assays to quantify the titer of neutralizing antibodies, both before and post-treatment.

Cell-mediated immune response

Activation of T cells after antigen administration generally results in secretion of cytokines that participate in the establishment of the immune response.

Cell-type immune responses triggered by administration of vaccination products or gene therapy can be characterized / quantified by ELISpot (Enzyme-Linked ImmunoSpot). This sensitive method derived from the ELISA method allows detecting and determining the frequency of secretory cells of cytokines (or other proteins).


AAV, Lentivirus, Plasmid, CRISPR, CarT Cells



MSD platform

ImmunoSpot S6 Core Analyzer





Victor X- luminescence

Odyssey Platform

Focus : AAV

A major problem encountered with AAV-mediated gene transfer is the immune response directed against the vector and / or against the transgene product. The monitoring of the immune response (inflammatory, humoral or cellular) is essential to evaluate the safety of AAV vectors. At GenoSafe, we ​​have implemented a wide range of solutions to evaluate these immune responses.

The specific immune response of AAV vectors is mainly of the humoral type. It is now widely reported that there is a high prevalence of AAV vectors in human and in various species due to exposure to wild type virus from which the vector was engineered. As part of a clinical trial it is recommended to monitor the level of neutralizing antibodies before and following the administration of the product.

In addition to the antibody responses, it is also important to consider the cellular immune responses.

The following solutions are available at GenoSafe:

  • Detection of anti-AAV neutralizing factors
    Methods available for serotypes: 1, 2, 5, 6, 8, and 9.
    Species: Human, NHPs, and easily adaptable to others species (rodents, dogs ….).
  • Detection of anti-AAV circulating immunoglobulin subclasses
    Methods available for serotypes: 1, 2, 5, 6, 8, and 9.
    Species: Human, NHPs, and easily adaptable to others species (rodents, dogs ….).
  • Detection capsid-specific T cell responses through IFN-γ ELISpot
    Methods available for serotypes: 1, 2, 5, 6, 8, and 9.
    Species: Human and NHPs.