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A Mixed Lymphocyte Reaction (MLR) is an in-vitro method for modeling cell-mediated adaptive immune responses. MLRs are one of the primary in-vitro assay formats for investigating the immunomodulatory potential of new drug candidates or gauging the relative immunogenicity of a therapeutic.
With many variations in format and readouts, the MLR is a versatile platform that can be utilized for nearly any therapeutic – drugs, antibodies, Cell and Gene Therapies (CGTs), Human Cells, Tissues, and Cellular-based Tissue Products (HCT/Ps), biomaterials, and more. Xeno Diagnostics provides expert MLR services for products at all stages of development. We tailor-fit the assay to meet the exact needs of the client – whether that is evaluating the mechanism of action, potency, immunogenicity, or transplant tolerance.
Regulatory guidance for industry rarely recommends one specific assay or technique that should be used to evaluate the immunological properties of a therapeutic; however, the information below is our best interpretation of where we believe the MLR can be best utilized to fulfill recommended guidance criteria associated with the ex vivo evaluation of immunological drug safety or efficacy. Check out our MLR applications page for additional information.
Discovery:
Preclinical:
Clinical:
Referenced Guidance Documents:
Our scientific team has compiled a great depth of knowledge and experience using the MLR in many different scenarios. Below is a listing of various Therapeutics, Animal Models, and Readouts that Xeno has used in the MLR:
Therapeutics:
Animal Models:
Readouts:
An MLR replicates an adaptive immune response via cell-mediated immunity. The MLR is one of the single best in-vitro tools available to assess how these therapeutics affect our immune system.
But just as our immune system is complex, so too is the MLR. An MLR is not a single specific assay, rather it is a classification of an assay type used to investigate how therapeutics either cause or modulate cell-mediated immune responses (e.g. allorecognition via MHC – TCR interaction). An MLR can be designed in a multitude of ways to replicate different mechanisms of cell-mediated responses (e.g. different types of allorecognition). Assays can involve purified subsets (e.g. Tregs) or depleted populations (e.g. CD8 depleted PBMCs). This flexibility affords the MLR the unique ability to adapt to the needs of a therapeutics mechanism, and to be tuned to investigate different parameters (e.g. immunogenicity, dose response, efficacy, bioactivity, etc.). Check out our pages on MLR variations and custom MLRs to learn more about how the MLR can be leveraged to your specific application!
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