ourStudies

Mar 25, 2020

The Science of COVID-19 and MarinBio (How MarinBio can help in test & vaccine development)

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Mar 30, 2020

Marin Biologic Laboratories, Inc., Founder CEO/President – Tania Weiss Ph.D.

Always an entrepreneur, Tania opened her first business in high school, she gave lessons in ...

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Mar 23, 2020

Covid-19: How Marin Biologic Laboratories Can Help With Testing

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Dec 12, 2019

Mixed Lymphocyte Reaction (MLR) Bioassays at Marin Biologic Laboratories

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ELISA Ultra Sensitive Detector of Proteins
Feb 21, 2019

ELISA (Enzyme-Linked Immunosorbent Assay) – Ultra Sensitive Detector of Proteins

ELISA is a quantitative and ultra-sensitive plate-based assay designed to detect and quantify substances such as antibodies, hormones, proteins (e.g. cytokines) and peptides, receptors on cells as well as small molecule drugs.

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Jan 24, 2019

Flow Cytometry of T and B Cells and NK Cells

Flow cytometry can differentiate different cell populations based on cell size by forward and side scatter measurements. Know about the analysis of B and T Lymphocytes and Monocytes in Human PBMC.

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Nov 28, 2018

5 Ways to Improve Your Cell Based Assay (Bioassay) Performance

5 ways to improve Cell Based Assays (Bioassays) performance from the Assay Experts at Marin Biologic Laboratories.

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Oct 11, 2018

New Website – Here was our Approach

What went into our thought process to develop a New Website.

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Marin Biologic – Justine Paniagua
Sep 20, 2017

Women in Science – Sr. Researchers and Lab Manager

We are creating a series highlighting women in science. We interviewed Tania...

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Marin Biologic – HUVEC Growth Inhibition
Sep 12, 2017

Cell Toxicity/ Apoptosis/ Inhibition of Proliferation

Cell death, overt death or inhibition of growth, occurs by several mechanisms...

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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.