ImmunXperts SA

The key process in T cell dependent antibody production is peptide presentation by antigen presenting cells to T cells, in combination with co-stimulatory signals and cytokine secretion. These three signals will stimulate the T cells to proliferate and differentiate, in order to be able to help the B cells to produce antibodies towards the antigen. Antibodies produced towards the administered drug (anti-drug antibodies or ADAs) are the main clinical immunogenicity problem. These ADAs can lead to a decreased or enhanced clearance of the drug, or can have no effect at all. If the drug mimics an endogenous counterpart, the ADAs might also bind the endogenous protein, which can lead to severe consequences for the patients’ health. The process from antigen presentation until ADA production cannot (yet) be tested in vitro. Therefore, T cell proliferation is can be used as a surrogate marker to measure the immunogenic potential of a drug candidate in development.

T cell activation assays have a long tradition in vaccine testing (wanted immunogenicity), but are also employed to asses possible unwanted immunogenicity induced by therapeutic proteins.

ImmunXperts offers several types of T cell activation assays:

• Whole PBMC assay: In the PBMC assay, complete test products are added to cultured peripheral blood mononuclear cells (PBMC). These cells contain all essential components to mount an immune reaction. After a period of incubation T cell activation is measured.
• DC-T assay: When test products interfere with the formation of an immune response, the DC-T assay type is preferred. Here, the test product is first loaded onto the surface MHC molecules of professional Antigen Presenting Cells (APC) and leftover product will be washed away. The APC will present all epitopes to autologous T cells and T cell activation is measured.

ImmunXperts has experience with several readout formats:

• Flow Cytometry: Multiparameter analysis on a single cell level
• Cytokine Profile: Capture beads allow the multiplexed analysis of more than 10 inflammatory cytokines
• ELISpot: Analysis of secreted molecules on a single cell level

ImmunXperts offers a comprehensive package of tools and services to measure immunogenicity during pre-clinical and clinical studies.

• In Vivo models for immunogenicity research
• Pharmacokinetic (PK) assays
• Pharmacodynamic (PD) marker analysis
• Anti-drug antibody (ADA) analysis and characterisation
• Neutralising antibody (NAB) analysis
• Potency assays

Recent advances in the field of Immuno-oncology have shown great promise in the treatment of a wide variety of malignancies. Several strategies involving monoclonal antibodies (or other biologics platforms), cytokines, small molecule compounds or cellular therapies have been applied to modulate the immune system.

Early evaluation and screening of the immunomodulatory effectiveness of candidate therapeutics using In Vitro bioassays is a critical step in the development of novel or combination immunotherapies.

ImmunXperts has extensive experience with In Vitro assays using human primary immune cells which can be implemented in the field of immuno-oncology, for instance:

• Mixed Lymphocyte Reaction (MLR) Assays
• Antigen specific T cell activation Assays
• Macrophage Polarization Assays

ImmunXperts has a unique knowledge in building custom assays that can be useful to cell therapy companies

Cell Therapy products offer the potential of curing diseases that today have only palliative treatments in the best case.

The ability to produce large quantities of biological products with predictable quality and quantifiable potency is becoming critical. And this is also a regulatory requirement for phase III and commercialization.

ImmunXperts has the capacity to develop custom in vitro assays to screen immunomodulatory properties of Stem Cells, selecting the potency markers that make the most sense for each product.

Immunoassays Services

Bioanalytical Assays Services

Bioanalysis Services

Pharmacology & Toxicology Services

Immune Cell Assays Services

Functional & Cell Type Specific Assays Services

Specialized Cell-Based Assays Services

Cell-Based Assays Services

Biology Services

Cytometry Services

Cells and Tissues Services

In vivo Toxicity Testing Services

Toxicology Services

Protein Quantification Services

Protein Purification and Quantification Services

Protein Services

Biochemistry & Molecular Biology Services

ImmunXperts offers access to In Silico tools for immune profiling and lead optimization. In Silico tools are fast, sequence based and low cost, and thus are perfectly suited for assessing large numbers of lead candidates in an early development phase.

These tools can be used for:

• Epitope Identification: Identify which part of your sequence is at risk for being an epitope.
• Immunogenicity Risk Assessment: Asses and compare the overall risk of your molecules for inducing Immunogenicity.
• Deimmunisation (decrease unwanted immunogenicity): Small changes to your molecule’s sequence can lower the risk for immunogenicity, while retaining all functionality.
• Customized services: ImmunXperts is open to discuss the many possibilities that these In Silico tools offer.