Rapamycin, also known as Sirolimus, was discovered in 1965, when it was isolated from a microorganism in soil. Since its discovery, it has demonstrated useful immunosuppressive properties, which have been utilized in preventing the rejection of organ transplants. Rapamycin is a mTOR inhibitor that has an advantage over calcineurin inhibitors, such as tacrolimus and cyclosporine, since it is not ...
The selectivity of LC/MS/MS yields chromatograms appearing deceptively clean. Interferences such as plasticizers and matrix components can adversely affect quantitation via ion suppression. Co-eluting and/or isomeric metabolites in incurred samples can also interfere with quantitation. An LC/MS/MS assay for a drug and one metabolite (M1) provides a case study demonstrating ways to locate and ...
Purpose. In order to increase the sample throughput of a manual LC-FL assay for ketoconazole, the method was automated and a multiplexed HPLC system was employed.
Methods. The original ketoconazole method involved manual protein precipitation, followed by HPLC-FL analysis with a run time of approximately 15 minutes. The sample preparation was converted to the 96 well format and automated using ...
Caffeine and its metabolites are ubiquitous in human biological fluids due to dietary consumption. The metabolites of caffeine are paraxanthine, theobromine and theophylline. The ratio of paraxanthine to caffeine may serve as a surrogate measurement of liver function, and thus, there is much interest in monitoring these two analytes simultaneously. Often times, the interference of theophylline to ...
BASi has developed a sensitive, specific and robust method for detecting and quantifying oxycodone and its two major metabolites, noroxycodone and oxymorphone, in human plasma. The assay is performed using LC-MS/MS to quantify these analytes along with three isotopically-substituted internal standards, d oxycodone, d oxymorphone and d 63 3 noroxycodone.
This assay addresses an important aspect ...
Process variability is a leading cause in biopharmaceutical batch failure and impacts the value and profitability of the industry. Thermo Fisher Scientific controls inherent variability through the use of the Thermo Scientific Antaris line of Fourier transform near-infrared (FT-NIR) spectrometers.
Robert J Broeze is the President and Chief Executive Officer of Laureate Pharma. He has over 20 years of experience in the biopharmaceutical industry, with technical expertise spanning research, development, characterisation, validation and current Good Manufacturing Process (cGMP) manufacture of biopharmaceutical products, from pilot to phase III clinical and commercial scale with a strong ...
Purpose: A generic approach is presented that provides concrete, statistical
evidence for acceptable method performance prior to initiating a bioanalytical
method validation.
Methods: A large number of replicate spiked matrix samples are analyzed in a
single batch before a method validation is started. Careful selection of the
contents of this batch enables one to evaluate factors such as ...
Ribavirin is an antiviral prodrug used for the treatment of Hepatitis C and respiratory syncytial virus (RSV) among other common viruses. A method for the analysis and quantification of ribavirin in rat plasma utilizing HPLC-MS/MS with updated HPLC column technology has been developed and validated according to the FDA guidance to the industry.
The assay displays good linearity with ...
Introduction Amprenavir is a second generation human immunodeficiency viral protease inhibitor marketed as Agenerase by GlaxoWellcome under license from Vertex Pharmaceuticals. The drug has demonstrated both additive and synergistic pharmacological activity against HIV in combination therapies involving both protease and reverse transcriptase inhibitors. The goal of this work was to extend our ...
Lightning-Link™ Antibody Labeling Kits use a one step procedure which means that you can generate high quality labeled antibodies with ease, and hands on ...
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