MARINBIO: Excellence in Cell Based Assays, FDA Compliant for Commercial Pharmaceuticals | LEARN MORE

ourNews & Blog Posts

Jul 10, 2024

From Code to Cure: How AI-Engineered Antibodies are Transforming Immunotherapy

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Jul 9, 2024

Developing Validation and Potency Assays for Oncolytic Cancer Immunotherapy Viruses

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Thumbnail image of a scientist working with a flow cytometry machine at Marin Biologic Laboratories.
Jun 7, 2024

Flow Cytometry and Cytokine Analysis: Advancing Drug Discovery at Marin Biologic Laboratories

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Immune cells interacting in an autoimmune response, representing innovative immunotherapy treatments.
Jun 7, 2024

Immunotherapy for Autoimmune Diseases

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Jun 7, 2024

Implications of Omicron BA.5 for Future Vaccine Development

As new cases of COVID-19 soar, experts warn about the newly emerged COVID subvariant BA.5, a sub-lineage of BA.2. Subvariants of Omicron BA.1 emerged in 2021, BA.2 in early 2022 and BA.5 came in April 2022.

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Researchers conducting cell-based assays in a high-tech biotech laboratory
Apr 12, 2024

Beyond Precision: The Critical Role of Validated Potency Assays in Drug Development

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Targeted Radiopharmaceutical Therapy - a fusion of medical innovation and precision targeting displayed in a thumbnail image.
Mar 27, 2024

Radiopharmaceutical Drugs: Harnessing the Power of Targeted Radiation Therapy to Combat Cancer

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Insightful image of a woman with a weighing scale, symbolizing the personal aspect of innovative obesity and diabetes treatment.
Feb 22, 2024

Transforming Metabolic Health: New Drug Breakthroughs in Obesity and Diabetes

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A split image of a woman with aging and youthful sides, encapsulating the science of anti-aging.
Jan 5, 2024

Slowing the Clock: Marin Biologic’s Insights in Anti-Aging Research

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Photorealistic image showing ADC molecules binding to a cancer cell, illustrating the precision of cell-based assays in cancer treatment
Nov 20, 2023

Advancing Cancer Therapeutics: The Role of Potency Assays in ADC Effectiveness

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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.