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While much of the focus on treating COVID-19 and preventing its spread has been on antibodies, emerging research is indicating that T cells of the adaptive immune system are equally...
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Vaccine development is protracted and risky. On average, vaccines take more than 10 years to move from the preclinical phase to approval, and the probability of market entry...
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The unprecedented scale of scientific effort being applied to countering the pandemic is already beginning to bear fruit. Current estimates of the infection fatality rate (IFR) have been...
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There are two types of tests being conducted in addressing the COVID-19 disease pandemic. The more commonly administered test is a qPCR assay designed to detect genomic material (RNA in this case) from the SARS-CoV-2 virus that causes the disease...
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As of the beginning of June 2020, we are still in the early stages of the COVID-19 global pandemic. Many questions remain unanswered as to whether an effective vaccine can be produced...
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HISTORY OF INITIATING THE FDA - Early drug development in Europe rested with the people who tanned
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BACKGROUND: With the discovery of DNA polymerase in 1956, an enzyme that replicates DNA, a new world...
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The diagram above represents the infiltration from the blood vessels of the immune cells (see below) into...
read moreIn 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.
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.
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.
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.
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.
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.
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.
