Case Study:

Immune Risk Assessment



What was the challenge?

Acquiring critical information on the immunogenic property of a compound prior to clinical trials could be pivotal in avoiding patient risks and attrition due to costly drug failure. The immune system is a very complex system consisting of various innate and adaptive cells of different lineage with different and often overlapping pathways and functions. The possibility of a drug, vaccine, biomaterial, cell or tissue to have immuno-modulatory and immunogenic property is always great. The immune risk assessment is necessary and there are many aspects of testing immunologic risk.




PBMCs of COVID-19-negative volunteers were induced with SARS-CoV-2 antigens in an in vitro human CRA and measured for release of inflammatory cytokines at 24hrs. M protein was a potent inducer.

Cytokine levels in individual PBMCs after stimulation with the M protein. Some donors very high for all cytokines are at risk.


Vaccines against SARS-CoV-2 corona virus can be designed using the S protein, and also the entirety containing the M protein. The virus is suspected to cause cytokine storm in some patients.  What is the possibility of any of these free proteins released from the vaccine to cause a serious adverse immune response?


We took purified full length and peptide forms of the S protein and M protein of SARS-CoV-2 to test in a cytokine release assay (CRA) for the secretion of cytokines associated with cytotoxicity.


  • The M protein is a very potent inducer of inflammatory cytokines. The S protein and peptides of S region can be immunogenic to some extent.
  • Vaccines that may release the M protein can be the cause of cytotoxic immune response in certain individuals. This is a major immune risk of the M protein of SARS-CoV-2.

Added Value:

  • Information on signaling pathways related to SARS-CoV-2.

Immune Modelling & Experimental Design

Immune Risk Assessment

Tissue Damage & Cytotoxicity

Immuno-Oncology & Immunotoxicity

Inflammation & Systemic Diseases

Vaccines, Drug Delivery & Transfection

Signalling Pathways

Looking for a tailored solution?

Of course, there is no one-size-fits-all solution for most studies. Immundnz specializes in developing tailored assays to enable you to challenge the status quo in your research.


Some of our popular assays

To accelerate your research and deliver high-quality data, Immundnz offers a broad spectrum of standardized, proven assays that are readily available.

M1/M2 Polarisation

M1/M2 are important in studies of various therapeutic areas and biological pathways.



Phagocytosis is an immunologic mechanism involved in apoptosis, necrosis, infection and tumour conditions mediated by leukocytes like macrophages, DCs, and neutrophils. 

Cytokine Release Assay

Cytokine release assay (CRA) is vital in biopharmaceutical discovery and development and life science research.


Dendritic Cell Maturation

Dendritic cells (DCs) are the star antigen-presenting cells (APCs) of myeloid or haematopoietic origin that play a vital role between the innate and adaptive immune systems. 


T Cell Differentiation

The T cell proliferation assay can be used to assess modulation of the T cell response by (immunomodulatory) compounds.


Immune & Protein-Based

We perform various immunologic and protein-based assays that are needed in your research or drug development.


Case Studies

Immundnz has performed many case studies, some of which are described here. You can always reach out to us for other examples of projects we have done.


Immundnz shares insights on in vitro immunology research for drug discovery on its blog, which is regularly updated by experts in the field.