News | March 20, 2007

Bioresearch Online Interview With Kirby Pilcher And Dr. George Rodrigues, ARTEL

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The editorial staff recently sat down with Kirby Pilcher and Dr. George Rodrigues to discuss liquid handling quality assurance and the solutions that are available to avoid potentially expensive and risky pipetting disasters. Kirby is the President and Dr. George Rodrigues the Senior Scientific Manager of ARTEL in Westbrook, ME. Enjoy the discussion.

What are the consequences of liquid handling error?

Pilcher: Most laboratories own more individual pipettes and liquid handling instruments than any other type of calibrated equipment. In fact, there are about 10 million pipettes in use in laboratories today. Yet our research shows that up to 30 percent of liquid delivery devices are malfunctioning at any given moment. This is a serious issue with extremely costly consequences.

Rodrigues: For example, consider drug discovery laboratories. Dispensing reagents in volumes inaccurate by even tiny amounts can alter concentration and prevent the identification of a reaction between compounds - the foundation for a new drug. These "false negatives" may cause a laboratory to miss the next breakthrough drug, and you simply cannot put a dollar value on that loss.

The cost of "false positive" results must also be considered. "False positives" can lead companies to sink time and resources into pursuing dead end projects. Many drug target "hits" are pursued through initial discovery stages only to be proven ineffective down the pipeline. And this wastes valuable and scant resources.

Pilcher: Inefficiency is another consequence of error. Pharmaceutical companies are under enormous pressure to bring products to market more quickly and cost-effectively. For truly streamlined operations, efficiency must be integrated throughout the entire research and development process. This includes liquid handling operations. And in today's laboratories, the need for liquid handling quality assurance is growing. In fact, since 2000 ISO has issued seven new standards for liquid delivery calibration technologies.

What's causing this need for more stringent liquid handling quality assurance processes?

Pilcher: Laboratories are facing several challenges that are emphasizing the need for advanced liquid handling quality assurance methodologies.

The mounting focus on quality in the pharmaceutical industry is quite apparent. Although quality assurance has long been a critical component of downstream pharmaceutical processes such as manufacturing and packaging, upstream functions such as R&D have not faced such intense scrutiny. Recently, though, productivity factors such as quality demands, process controls and advancing regulations are causing laboratories to tighten quality control programs earlier in the development cycle.

Another challenge to laboratories is the trend toward smaller liquid volumes, causing inaccuracy of just one microliter to have significant effects on data. Smaller volumes are more sensitive to environmental conditions and pipetting technique, whether equipment is manual or automated. Laboratories need quality assurance technologies capable of low volume measurement.

Rodrigues: There is also growing alarm that large investments in laboratory automation have failed to result in productivity gains. Laboratories are looking for methods that can optimize processes of their automated equipment and enhance productivity. Laboratories are also plagued by a scarcity of resources. Technician workloads are growing due to a shortage of adequately trained personnel. And training is critical given that operator technique is the largest source of liquid handling error, causing more than 50% of all liquid handling mistakes.

To avoid wasting time and resources, laboratories not only need assays and experiments to be correct on the first run, but also need a convenient method to ensure this.

Pilcher: Also, continued globalization will make the need for inter-laboratory comparability and standardization critical. For example, it is common for pharmaceutical companies to develop an assay in the US and then transfer it to a manufacturing facility overseas. The use of standard methods can smooth this transition.

What is ARTEL doing to address these needs?

Rodrigues: ARTEL is helping laboratories optimize their liquid handling processes through innovative systems and services based on ratiometric photometry.

Ratiometric photometry relies on known light absorption properties of two proprietary dyes at specific wavelengths to verify volume with a high degree of accuracy and precision. The technology is unaffected by the environment, even at low volumes and is recommended by ISO.

ARTEL's MVS® (Multichannel Verification System) and PCS® (Pipette Calibration System) are based on ratiometric photometry. Usable quickly and conveniently at the bench-top level, these systems can be used for frequent calibration, verification and optimization of liquid handing operations to strengthen data integrity. Providing NIST-traceable results, these systems are also standardized to allow for inter-laboratory comparability. This means calibration results will be repeatable and consistent from operator to operator, instrument to instrument, lab to lab, location to location and day to day.

Pilcher: For laboratories that prefer to outsource liquid handling quality assurance, ARTEL offers the LHQA service suite to allow laboratories without our systems to benefit from our technology and years of liquid handling expertise.

The Liquid Handler Performance Verification Service provides third-party, documented assessment of equipment accuracy and precision and can be applied to most makes and models of liquid handlers, from single- to 384-channel devices.

ARTEL also provides Pipetting Technique Training and Certification to help laboratories reduce operator error as a source of liquid handling error.

Rodrigues: In addition, laboratory technology is continually evolving, and this is true of liquid handling technology as well. ARTEL continually upgrades its systems and services to keep up with advances in liquid handling and provide correspondingly advanced measurement and quality improvement tools.

For example, ARTEL has enhanced its MVS to provide laboratories with the first standardized technology to verify the accuracy of dilution ratios in serial dilution protocols.

In addition, ARTEL added several automation capabilities to its PCS, including barcode scanning, to meet customer demands.

Pilcher: ARTEL's mission is to help laboratories trust their results. Given that pipettes and automated liquid handlers are ubiquitous in life science laboratories and are used to generate critical data and experimental results, liquid handling quality assurance is essential for data integrity.

SOURCE: ARTEL