Research over the past 20 years has expanded the immune therapy path extensively. Understanding continues to expand in specific receptors, cytokines and other proteins that play a role in innate and acquired immunity. Our work has increased in this area with targeted immune therapies. There are specific tests that can be employed to test various aspects of immunotherapy depending on the outcomes being sought and the regulatory needs you seek.
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Immunoassays include the activities of B and T lymphocytes, granulocytes and monocytes/macrophages. These activities encompass antibody reactions, direct and indirect killing of target cells, allergies, inflammation, infectious disease, and regulation of ongoing aberrant immune responses, such as in autoimmunity and cancer. We have developed and performed hundreds of these types of studies for our clients including MLR, ADCC, cytokine detection assays, T cell activation by flow cytometry for intracellular or surface markers, T cell subset assays (e.g. NK, Th17), and 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.