How to Select a Contract Research Organization for the Caco-2 Permeability Assay?
When seeking to understand your compound suitability for oral dosing the Caco-2 permeability assay is widely accepted as the gold standard. Why the Caco-2 permeability assay is important The Caco-2 permeability assay is a United States Food and Drug Administration (FDA) required study for organizations applying for an Investigational New Drug (IND). Using the Caco-2 permeability assay companies partnered with a capable in vitro contract research organization (CRO) can predict the intestinal drug permeability and absorption of their test compound. In addition to information on drug permeability and absorption other assessments can be made using the Caco-2 permeability assay to deliver data on the efflux ratio. This data can then be used to determine whether a test compound is actively transported by P-glycoprotein (P-gp). ✓The Caco-2 permeability assay is FDA Required for IND submissions. ✓When run with a capable CRO the assay can predict intestinal drug permeability and absorption. ✓Additional assessments can be made, including whether a test compound is actively transported by Pglycoprotein (P-gp). How the Caco-2 cellline mimics the human intestine In humans, intestinal absorption is controlled by a barrier comprised of a single polarized layer of epithelial cells that line the intestinal wall. When cultured correctly, the Caco-2 human colon carcinoma cell line actually mimics epithelial barrier seen in humans forming a well-differentiated monolayer of cells. Within this monolayer of cells an apical brush border contains many of the proteins found in the
human intestine that mediate the active uptake or efflux of drugs and chemicals. Due to the Caco-2 cell line’s ability to mimic intestinal absorption in humans the cell line makes for an ideal in vitro model when studying a compound's readiness for oral dosing. How to select a CRO to run a Caco-2 study Over the past 10 to 15 years there has been a massive increase in the number of CROs running in vitro studies. This growth in in vitro contract research organizations is in a large part due to a push from regulatory bodies for alternatives to animal testing methods. However, the question remains, with so many options to choose from, how can researchers best select a quality CRO for running in vitro studies like the Caco-2 permeability assay? When seeking to run a Caco-2 permeability assay, the key parameters to look for are: 1. Experience 2. Specialization 3. Regulatory compliance To verify these three items, First, review the organization's website for details about the assay. When looking at the organization's website find the page or section on their Caco-2 permeability assay. The Caco-2 permeability assay will often fall under a category of services known as “ADME”. When looking at the website page or section ask, “does this company give enough details about the Caco-2 permeability assay?” Although not a perfect test for experience, in general, doing this does lend confidence to the fact that the company has actually run the assay before. Second, ask, “does this organization specialize in in vitro methods?” This verification can be done online or with a phone call, but the principle remains the same. The increase in demand for in vitro studies has led many organizations that do not traditionally specialize in vitro research, as a service, to begin offering in vitro studies, such as the Caco-2 permeability assay. Companies who have recently moved into the in vitro space as a service provider often have less experience in running in vitro assays for clients. This leads to less capable in vitro data interpretation and less experience interacting with clients around in vitro work. In fact, many companies setting up new in vitro laboratories hire from contract research organizations specializing in in vitro testing. Going right to the source will help ensure quality through specialization. Finally, when seeking to run a Caco-2 permeability study, check to see if the company follows GCCP and GIVIMP guidelines. This is another good indicator of experience with in vitro methods. A good in vitro CRO will have a copy of these guidelines in every laboratory. Questions to ask in summary: ✓Does this company give enough details about the Caco-2 permeability assay? (lends confidence to the company’s experience with the assay) ✓Does the organization specialize in in vitro methods? ✓Does the organization follow GCCP and GIVIMP guidelines?
If yes to all of the above questions, there is a good chance you have found a reliable in vitro partner to run your organization's Caco-2 permeability assay. IONTOX, L.L.C. is a contract research organization specializing in vitro methods following both GCCP GIVIMP guidelines. On the company’s websitepage for the Caco-2 permeability assay can be found detailed information about the Caco-2 permeability assay including controls, an apparent permeability coefficient equation, and assay lead time. For more information on the Caco-2 permeability assay as offered by IONTOX click, learn more about the IONTOX Caco-2 permeability offering. IONTOX offers a live chat online and easy of contact via phone, email, or online forms.
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