Often our clients want the specific expression of a protein, or siRNA, whether the DNA is transiently or stably transfected. For clients needing a customized assay, for long term drug release, our collaboration revolves around stable transfections. For those clients needing to test the expressed protein, a transient transfection is generally the direction.

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MANY METHODS
ONE DESIRED OUTCOME

There are a variety of methods that will accomplish transfection of mammalian cells. These methods range from liposomal vesicles, chemical based (Calcium phosphate), polymers, non-chemical based and viral methods, some of which have been utilized for decades, others of which are fairly new. For transient transfections, the time-line is several days, but for stable transfections, the time is several weeks. Part of our mutual consideration is to select the methods most appropriate for your project.

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.

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.

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.

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.

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.

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.

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.

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.

OUR KEY
MULTI-DISCIPLINARY UNDERSTANDING

The scientists at Marin Biologic have experience in a variety of methodologies for transfections and have made hundreds of stable cell lines, expressing the protein of interest. With our understanding of molecular and cell biology, and embedded cell culture technique, we efficiently complete your project providing weekly updates. If you need to have your gene of interest expanded, we’re here to help you prepare your reagent prior to transfection, too. Our goal is to test for the best expressing clones that are selected with the antibiotic.