March 07, 2012 -- Three novel methods have been developed by the Bioanalytical Group at Frontage Laboratories, Inc., a global pharmaceutical contract research organization (CRO). Developed to support clinical trials, the methods were just accepted for publication as abstracts at the May 20-24, 2012, American Society for Mass Spectrometry conference in Vancouver, BC, Canada.
The first of the three new methods resulted from a Frontage partnership with Sunovion Pharmaceuticals, Inc. Highly sensitive and specific, the 2-in-1 LC-MS/MS method measures human serum levels of ciclesonide, a once-daily inhaled corticosteroid, and its active metabolite at a lower limit of quantitation of one picogram per milliliter. This concentration is lower than any level found with previously published methods.
The second new Frontage method is the first one available that enables simultaneous quantitation of ethinyl estradiol and norgestimate, which is a combination oral contraceptive, as well as a metabolite of norgestimate. The Bioanaltyical group overcame the challenging sensitivities, interferences and instability issues that had prevented previous analytical methods from simultaneously quantifying all three analytes.
Finally, Frontage developed a novel and ultrasensitive method for determining human plasma levels of fluticasone furoate, an enhanced-affinity glucocorticoid used to treat allergy symptoms. This technique employs liquid chromatography tandem mass spectrometry using atmospheric pressure photoionization with a novel mobile phase incorporated dopant to increase sensitivity and specificity. With a lower limit of quantitation of 0.2 picograms per milliliter, the ultrasensitive method fulfills a need specified by clinical bioequivalence trials.
Frontage Laboratories, Inc. is a global contract research, development and manufacturing organization, offering a full range of pharmaceutical R&D services. Frontage operates in the US and China, using one seamless GXP platform. Frontage runs three Phase 1 Clinical units, a 72-bed Phase 1 Unit in Hackensack, NJ, a 120-bed Phase 1 Unit in Zhengzhou, Henan Province China, and a-80 bed Phase 1 Unit in Changchun, Jiling Province China. Frontage has an AALAC certified preclinical animal facility in Pennsylvania, where it also maintains bioanalytical and CMC facilities. In Shanghai and Beijing, China, the company also operates bioanalytical and CMC facilities. As a rapidly expanding CRO with ten years of success providing high-quality GXP services, Frontage has established an international standard in pharmaceutical product research, development, quality and management systems.