Speed Your Immunotoxicology Testing With iTox3 Assays and Complementary Automation

When it comes to drug development, one hurdle every drug candidate must clear is immunotoxicology—or more specifically, immunophenotyping. During this phase, pharmaceutical companies evaluate each drug candidate for its effect on the immune system—either by accident or design—before they invest millions of dollars and years of development time to bring that drug to market.

In light of this requirement, labs that perform immunophenotyping are valuable assets in the drug development process. And, if your lab is one of them, odds are your workload is on the rise. After all, there are more drugs in development than ever before and regulatory agencies like the U.S. Federal Drug Administration (FDA) are stepping up their efforts to identify possible immune system problems early in the development process.

To address these market trends, more and more labs are facing the need for rapid, easy-to-use immunophenotyping assays that can be automated for greater efficiency and cost effectiveness over time.

Thanks to Beckman Coulter, one new solution is iTox3, which simplifies and automates immunotoxicology T/B/NK phenotyping testing with ease.

Introducing iTox3
Released worldwide in August 2006, iTox 3 reagents offer rapid and accurate enumeration of Rat T-, B- and NK-cell populations including CD4+ and CD8+ T-cell subpopulations. These multicolor, ready-to-use reagents help researchers eliminate drugs with poor toxicity profiles, thus reducing the costly risk that a drug candidate will fail during later in vivo or clinical testing.

Analysis is detectable using Beckman Coulter's FC 500 or FC 500 MPL flow cytometry systems, or with a compatible flow cytometer (without performing extra validation). The iTox reagents also come with a validated sample preparation procedure that provides reproducibility, ease of use and the ability to run prepared samples on any suitable flow cytometer.

The iTox3 reagents offer a no-wash lysing procedure, are compatible with cell-viability assessments and are activation-marker ready. Plus, they can be easily implemented manually or can be automated for optimal efficiency.

A Smart, Comprehensive Solution
Labs can further speed their immunophenotyping processes by adding complementary flow cytometry hardware and automation. These additional tools—namely, the FC 500 or FC 500 MPL flow cytometry system and the Biomek® NXP laboratory automation workstation—can create an end-to-end testing solution that increases productivity and efficiency.

Analysis on the FC 500 MPL
The FC 500 flow cytometer with dual laser excitation configuration expertly handles the three-color iTox3 assays, without clever fluorescence compensation. For labs that need to delve deeper into the immune status, the FC 500 Series has the capacity to conduct five-color analysis easily, implementing the easiest and most accurate method of color compensation, Advanced Digital Compensation (ADC).

For labs needing greater flexibility and convenience, the Multi-Platform Loader (MPL) option of the FC 500 Series provides the capability to automate sample loading using microtubes arranged on a 96-socket carrier rack. This system can accommodate:

• racks of 96 microtubes arranged on a 96-socket carrier
• racks of 40 standard 12x75 mm test tubes
• standard 96- or 24-well microtiter plates

Adding Automation
Your lab may also choose to automate its sample preparations on the Beckman Coulter Biomek® NX P laboratory automation workstation. This flexible lab solution puts every aspect of liquid handling—including pipetting, dilution, dispensing and integrations—into a single, small-footprint, automated system. The company has created a validated application for its Biomek liquid handling devices, which enables walk-away sample preparation and lower costs in sample preparation, from an industry leader in automation.

With automation, clinical research organizations can increase efficiency while retaining high accuracy. Plus, they don't have to hire more technicians, which can keep their costs down and help them sharpen their competitive edge with pharmaceutical companies.

According to Mark Cheetham, Product Manager, Beckman Coulter's Research Flow Cytometry, “By combining reagents, flow cytometry and robotic sample preparation into a single product platform, Beckman Coulter achieves a real feat in the research flow cytometry industry—enabling labs to simplify and automate their processes with a very unique flow cytometry solution.”