Understanding the challenges of immunotoxicity in pharmaceutical research

April 6, 2023

Pharmaceutical development is a complex process that presents numerous challenges, including ensuring the safety of drugs. One of the key areas of concern is the potential immunotoxicity of drugs, as this can have serious implications for patient health and well-being.

Immunotoxicity refers to the harmful effects of drugs on the immune system. This can include suppression or stimulation of the immune response, leading to increased susceptibility to infections or autoimmune disorders. Immunotoxicity can also lead to hypersensitivity reactions, which can range from mild allergic reactions to life-threatening anaphylaxis.

During the preclinical phase of drug development, potential drug candidates undergo rigorous testing to assess their immunotoxicity profile. This includes evaluating the effects of the drug on the immune system, such as its ability to induce immune suppression or trigger hypersensitivity reactions.

Unfortunately, most in vitro tests for immunotoxic assessment are either very simplistic (Human cell based such as PBMCs) or utilise in vivo humanised animal systems. Both approaches have major downsides around their relevance to predict immunotoxic responses (too simple or not human).

Clinical trials also play a critical role in assessing the immunotoxicity of drugs. The immune system is carefully monitored throughout clinical trials to identify any adverse effects that may arise as a result of drug treatment. This includes monitoring for changes in immune cell counts, cytokine levels, and other markers of immune function. However, trials are expensive to run and catastrophic when they fail. More effective pre-clinical screening assays could save the industry billions in lost revenue and wated efforts by identifying failed candidate sooner in the pipeline.

Alcyomics’s Skimune® assay bridges the gap between simplistic cellular assays and clinical trials by providing tissue based immunotoxicity assessment which gives clinically predictive data on a wide range of mechanistic outputs. We’ve validates our model for small, large molecules, cellular therapies and more. We have published data widely which demonstrates our capabilities to predict clinical outcomes before going into Phase 1 trials, giving our clients peace of mind that their investment is well spent.

Ensuring the immunotoxicity of drugs is carefully evaluated throughout the development process is crucial for protecting patient health and well-being. The potential for immunotoxicity must be carefully considered during all phases of drug development, and appropriate measures must be taken to minimize the risk of harm to patients.

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