Cell-mediated immunity is an immune response that does not involve, but rather involves the activation of antigen specific, cytotoxicT-lymphocytes, and the release of various cytokines in response to an antigen. These immune reactions affect cancer, infections, autoimmunity, and non-infectious inflammatory states (diabetes, stroke, heart disease, obesity, Alzheimer’s disease, depression, etc.)
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Immunoassays include the activities of subsets of T lymphocytes, granulocytes and monocytes/macrophages. The first stage is activation, which is measured by gene expression, changes in cellular antigens (activation markers measured by flow cytometry) and cell proliferation. The MLR reaction is an example where lymphocytes from one person detect foreign antigens in a test sample (e.g. a cell therapy) or in a second individual’s lymphocytes and initiate cell activation as described above. The “in vitro recall response” is an example of detecting T lymphocytes previously sensitized in vivo (tetanus or HPV vaccination, autoimmune status, CMV infections which is non-apparent in much of the population). This assay detects activation of the respective T cell subset by proliferation and cytokine production.
Further stages include production of cytokines, enzymes, prostaglandins, reactive oxygen intermediates, etc. End stage assays include killing of target cells by lymphocytes (NK, CTL, ADCC, neutralizing antibody assays), killing of microbes by granulocytes and macrophages, or stimulation or inhibition of other aspects of the immune system.
We have developed and performed hundreds of these types of assays for our clients including MLR, ADCC, cytokine detection assays, T cell activation by flow cytometry for surface markers, T cell subset assays (e.g. natural killer cells (NK), Th17), granulocyte and monocyte subset assays among many others.
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.
Whether we use human or animal blood, or spleen, lymph nodes or bone marrow samples, our veteran team can provide in depth awareness of what your data shows and how that fits into your needs. Alternatively, we use cell line models of primary cell responses for when precision or high throughput is required. Our depth of experience can help you identify which assay you may need or if you already know which assays are required, we can perform it in our lab accurately and timely.