Plainsboro, NJ, August 17, 2012 – XenoBiotic Laboratories (XBL) has enhanced its bioanalytical services with the acquisition of two Waters ACQUITY UPLC® I-Class coupled with Xevo™ TQ-S tandem mass spectrometers. Over recent months, these systems have been validated according to FDA’s 21CFR Part 11 requirements. The increased sensitivity of the Xevo™ instruments has afforded significant reductions in plasma sample aliquot volume while still maintaining the required high sensitive LLOQ, and/or allowed additional reductions in the LLOQ to as low as 0.1 pg/mL. XBL has applied these systems to several of its most sensitive bioanalytical methods currently in use for clinical sample analyses. For example, for the inhaled drugs fluticasone (a corticosteroid that works directly on the nasal passages to relieve seasonal and year-round, allergic and non-allergic nasal symptoms) and salmeterol (a long-acting Î²2-adrenergic receptor agonist used in the management of asthma and/or chronic obstructive pulmonary disease (COPD)), a reduction in the LLOQ from 3 and 4 pg/mL, respectively, to 0.4 pg/mL from a 0.5 mL plasma sample has been achieved for both compounds. For situations in which a low blood draw volume is the critical factor, we have also developed methods for these compounds that have reduced the sample volumes by 2-5-fold while maintaining pg/mL LLOQ values. In another example, for our bioanalytical assay for formoterol (another inhaled long-acting Î²2-adrenergic receptor agonist used in the management of asthma and/or COPD), XBL has achieved an LLOQ of 0.1 pg/mL from a 0.5 mL plasma sample.
Another recent implementation within XBL’s bioanalytical department to improve efficiency is the routine application of dual HPLC (Shimadzu Prominence Device) coupled with AB SCIEX API-5000 tandem mass spectrometers to significantly increase sample analysis throughput and bioanalytical operational efficiency. “These multiplexed LC-MS systems have allowed faster turnaround times for large batches of clinical samples that require the sensitivity of the API-5000”, commented Dr. Xinping Fang, VP, Bioanalytical Services, “we have also recently implemented direct to network acquisition of LC-MS/MS data that improves raw data security the data review process”.
The addition of state-of-the-art Waters UPLC®/Xevo™ LC-MS system is another example of how XBL continues to enhance its core services in the bioanalytical, non-clinical ADME, and metabolite profiling areas available to the pharmaceutical, biotechnology, animal health and agrochemical industries. XBL facilities in Plainsboro, NJ (www.xbl.com) and in Nanjing, China (www.xbl-china.com) operate to GLP standards, are licensed for radioisotopes, and are AAALAC accredited for animal research.
For further information, contact:
XenoBiotic Laboratories, Inc., 609 799-2295 or 888 XENO-880 (936-6880)