These buttons are the focus of most (but not all) of our work. Click one and learn more.
fficacy of mRNA vaccines on SARS-CoV-2 variants (UK and South Africa) Detection of mutations arising in the genome...read more
BioNTech in Germany is one of two companies (the other being Moderna in the US) that have successfully developed mRNA vaccines against...read more
Different types of vaccines work in different ways to offer protection, but with all types of vaccines, the body is left with a supply of “memory” cells that will remember how to fight that virus in the future.read more
SARS-CoV-2 is more virulent than SARS-CoV (identified in 2003), because it binds to host cells with greater affinity, and more recently (see below) uses another receptor to increase virus uptake into cells.read more
Some kits are suitable, but will they fit your purpose? The scientists at MarinBio find that some kits are appropriate for certain applications.read more
Cytokines are a broad and loose category of small proteins (5-20 kDa molecular weight) important in cell signaling, particularly in the regulation of immune system responses...read more
Innate immunity is the initial immune response to infectious agents, carried out mainly by granulocytes and macrophages. These include a variety of responses that...read more
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...read more
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...read more
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...read more
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.
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.