An MLR assay is typically used to predict the success of allographs, nonreactivity of stem cells, and pharmacological manipulation of the immune response. The MLR measures the activity between T lymphocytes to foreign antigens, usually cells bearing mismatched cell surface Major Histocompatibility Complex (MHC) proteins.
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Peripheral blood lymphocytes from two donors are co-cultured (two-way MLR) and the response is measured by proliferation, induction of cytokines and other methods. When the response of only one donor lymphocytes is desired (one-way MLR), the stimulating cells are inactivated, e.g. by mitomycin C treatment.
Typically, equal numbers of stimulator and responder cells are used. When drugs are being tested for stimulating immune responses, for example ICI (Immune Checkpoint Inhibitors), the standards are adjusted for maximum sensitivity.
When you need an assay to prove your science and there is no commercial kit available, you need a custom assay. Our extensive expertise will quickly and methodically develop your assay to prepare it for eventual validation. Typically an assay can be developed from scratch in 5 or less experiments while minimizing any matrix effects.
We are firm believers in kits. The analytical portion of the assay itself is only a single component of what it takes to perform a successful experiment. It is all the other skills, experience and GLP/GMP conditions that we do day in and day out that will save you time getting to the results you actually want yesterday. We can create and distribute kits, too.
Many companies planning an IND submission or in Phase I/II may only require a well-qualified assay rather than a fully validated assay. You may or may not need GLP/GMP stringency and auditability yet. Our scientific team works with your scientists to qualify your assay for reproducibility, appropriate precision and accuracy.
To validate an assay is to measure precision, linearity, accuracy, robustness, system suitability and repeatability. To achieve these results, we conduct multiple experiments in a pre-validation phase with the assay. This phase is a series of 2-4 experiments that specifically look at these capabilities. Once we have advanced an assay, we perform the assay 2 more times for a total of 3 identical repeats. At that point, your assay meets the FDA GLP or GMP requirements.
Whether patient samples or drug product samples we will map out a timeline and follow through with sample receipts, meeting your regulatory needs at all points. We perform your assay as developed, qualified or validated, and promptly communicate the results and/or Certificate of Testing for any or all of your preclinical or clinical phases.
Knowing the importance to the FDA of lot release potency testing, our scientific team tests every manufacturing lot with your assay providing Certificates of Testing in a timely manner, under GMP Condition.
In order to determine shelf life for a particular drug substance, stability tests are performed at pre-determined calendar intervals. Our project coordinators communicate closely with you to anticipate the arrival of samples so as to have our staff and resources available for timely analysis and submittal of data and Certificates of Testing.
Marin Biologic scientists have performed many MLR experiments, human, other primate, rodent, etc. We maintain tracking of blood donors for repeat analysis and can use frozen pairs of cells for reproducibility of results.