Some biotherapies such as vaccination are based on immune system activation, whereas others must avoid induction of an immune response. In both instances the ability to measure  the immunological responses is critical.

From preclinical steps to clinical phases, GenoSafe provides custom immunology testing services to support the follow up of immune responses in animals and subjects included in clinical trials:

Measure of cytokines, chemokines and growth factors

There is an increasing need of rapid, precise, and cost-effective measurement of soluble cytokines and other analytes in biological samples and cell culture supernatants.

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

  • Commercially available ELISA (enzyme linked immunosorbent assays) 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. Antigen-mediated capture of plasma/serum antibodies enables determination of antigen-specific antibody “titer”.

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

Neutralizing antibodies prevent the entry of a virus to the cell. This effect is usually desired for vaccination and detrimental when using virus as a vector for gene therapy.

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

Cell-mediated immune response

When they are presented with peptide antigens, activation of T cells results in the secretion of cytokines that assists the immune response.

T cell-mediated immune responses to vaccine or gene therapy product can be quantified through the use of the Enzyme-Linked ImmunoSpot (ELISpot) assay. This sensitive ELISA-derived method allows to detect and count cytokines (and other proteins) secreting cells.

Focus : AAV

One major problem encountered during in AAV-mediated gene transfer is the immune responses directed against the vector or against the transgene product, or both. Immune system monitoring (cell-mediated or humoral immunity) is essential to evaluate the safety of AAV. At GenoSafe we have implemented a large panel of solutions to evaluate those immune responses.

Immune response to AAV is primarily a humoral response. The widespread exposure to numerous AAV serotypes within the human population is well known and documented. Therefore the immune responses to AAV vector will be influenced by the prior exposure of the human immune system to the 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.