ourStudies

Oct 8, 2021

Monoclonal drugs in high demand for severe COVID-19 infections; supply issues a concern

Regeneron’s antibody cocktail for treatment of COVID-19 infection (REGEN-COV, comprised of monoclonals casirivimab and imdevimab) was approved by the FDA in October 2020

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Sep 13, 2021

Emergence of the Delta strain as the dominant variant of SARS-CoV-2 worldwide

In a classic case of Darwinian selection, the successful Delta variant (B.1.617.2) has largely displaced all other forms of the coronavirus underlying the ongoing global pandemic.

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Therapeutic Antibodies
Aug 26, 2021

Strategies For Generating Stable Cell Lines For Producing Therapeutic Antibodies

Recombinant monoclonal antibodies are one of the most promising drugs (immunotherapy) for human diseases which include infectious diseases, cancer, and various other diseases.

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Aug 17, 2021

Purification of Therapeutic Antibodies

Therapeutic antibodies have become an important class of protein drugs for the treatment of numerous human diseases as well as uses in immunoassays. Nearly 100 monoclonal antibody-based drugs have been approved for the treatment of immunologic diseases and cancer

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Feb 19, 2021

COVID-19 Vaccines Protect Against 2 SARS-CoV-2 Variants

fficacy of mRNA vaccines on SARS-CoV-2 variants (UK and South Africa) Detection of mutations arising in the genome...

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Feb 17, 2021

Potential mRNA vaccine for MS

BioNTech in Germany is one of two companies (the other being Moderna in the US) that have successfully developed mRNA vaccines against...

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Dec 24, 2020

How Coronavirus Vaccines Work?

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.

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Nov 20, 2020

Why is SARS-CoV-2 so virulent?

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.

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Buy a Kit
Oct 28, 2020

Why Not Just Buy a Kit?

Some kits are suitable, but will they fit your purpose? The scientists at MarinBio find that some kits are appropriate for certain applications.

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Multiplex Cytokine Measurement Analysis
Jul 28, 2020

Multiplex Cytokine Measurement Analysis

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...

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QUICK READS

From the beginning and ongoing, your assay is a critical component of the life cycle of your current or eventual product. That is precisely why you want experience and expertise at the earliest possible stage of your development.

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.

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