The beginning of a new year is always an exciting time, filled with hopes of bigger and better things. AIT Bioscience has set the tone for 2010 with its new automated systems. The new Watson 7.4 LIMS and its embedded TSQ module for the Thermo Vantage mass spectrometer in particular have improved lab efficiency by eliminating human error.
“AIT Bioscience was the first CRO to have the Watson version 7.4 installed,” said AIT Bioscience Business Development Manager Michael Coon. “This software program is capable of controlling the LC-MS/MS instruments and processing resulting peak data.”
According to Coon, this advanced software helps to set AIT Bioscience apart from its competitors since settings for the liquid chromatography and mass spectrometry instruments as well as raw data, processed data, and study tables are stored in Watson. Data files for a study distributed across several analytical systems are automatically collected in one database, which simplifies validation, final reporting, audits, and archiving.
The Hamilton Star liquid handling robot is another automated system that has increased the lab’s efficiency. AIT Bioscience uses it to build, from stock and blank matrix, all of the required working standards and matrix calibration standards and then aliquots all samples to 96 well plates. The samples are bar coded so they can be placed on the deck in any order. Trace files are retained to show the reconstructability of the process, and a fresh calibration set is prepared consistently for every run. As an example, the laboratory implemented a method ranging from 5 to 5,000 pg/mL in plasma, using liquid-liquid extraction in deep well plates. The Hamilton-generated standard curve and QC sample results consistently presented CVs of three percent or better at the 15-, 375-, and 3750-pg/mL levels.
“This LLOQ represents a significantly more sensitive analytical method than those generally used for clinical applications,” said Coon. “Scientists developing compounds for eventual FDA approval are required to accurately describe how each compound is metabolized inside animals and humans. Necessary pharmacokinetic calculations are made more accurate by using thorough analytical methods with LLOQs as small as possible.”
Along with the Thermo TSQ Vantage and Hamilton Star, AIT Bioscience has standardized the Waters Acquity UPLC® system and Tomtec 96-well workstation to offer a harmonized package of services. The Waters Acquity UPLC® system is an established leader in sub-2µm particle liquid chromatography, allowing AIT Bioscience to achieve superior chromatographic separation and sensitivity while also accelerating LC-MS/MS analyses. The Tomtec 96-well platform is the industry-standard workhorse for high-throughput parallel sample processing. AIT Bioscience will design selective 96-well plate schemes based on solid-phase and liquid-liquid extractions to provide the most robust analytical method.
However, even with a variety of cutting-edge technology available in production, AIT Bioscience still relies on highly skilled chemists to run it. “AIT Bioscience staff has proven reputations for providing high-quality bioanalytical data within the highly regulated GLP environment,” said Coon. “Given the electronic and software systems we are building, we will provide data in a cost-competitive, rapid manner.”
The decision to create AIT Bioscience was made in early 2009, born from the desire of its parent company, AIT Laboratories, to improve upon the traditional CRO model. Led by industry veteran Ronald Shoup, Ph.D., the new company will provide clients with the capability to monitor sample activity from point of collection to the final report in a completely paperless environment. Instead of addressing issues after the fact, the company will implement novel electronic systems to prevent errors in real time. AIT Bioscience will be fully operational this year.
For more information about AIT Bioscience, contact Regional Business Development Manager Janna Chambers at jchambers@aitbioscience.com or call toll-free at 800-875-3894.
About AIT Bioscience:
AIT Bioscience, LLC, headquartered in Indianapolis, Ind., is a bioanalytical contract research organization supporting pre-clinical trials and all phases of clinical development. AIT Bioscience’s mission is to create a new standard for quantitative bioanalytical analysis and drug development in support of small biotech and large Pharma companies.