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Bioanalytical Case Studies

Picking Up the Pieces

A client required a method developed and validated for an endogenous drug compound (used as an antineoplastic) in human plasma at low ng/mL concentrations. After validation, multiple plasma samples from a double-blinded infant study required analysis. The client had outsourced the method development and validation to another CRO who had issues maintaining reliability, precision, and accuracy. When Cyanta was awarded this study, our bioanalytical scientists developed an LC/MS/MS method with the desired limit of quantitation. The method was validated to meet the requirements of the FDA's Bioanalytical Validation and Crystal City Guidelines. Known concentration quality control samples were put on a long term stability study. A formal detailed validation report was prepared and submitted to the client. After validation was completed, approximately 1,200 plasma samples from the double-blinded infant study (some of which had been in freezer storage for approximately two years) were analyzed. Analysis included approximately 10% sample reanalysis for incurred sample reproducibility. A formal sample analysis report was prepared and submitted to the client.

Exotic Analysis

A client required a method, previously developed, to be transferred and validated for a drug compound (a microbicide with antiretroviral properties) in non-human primate matrices (tissue, plasma, and red blood cells). After validation multiple samples of each matrix from a non-clinical non-human primate study required analysis. The client had outsourced the method development to a non-GLP facility and wanted the method validated in compliance with FDA and Crystal City guidelines. The client also required that the limit of quantitation be established at or below 1 ng/mL in each matrix. When Cyanta was awarded this study, our team of bioanalytical scientists successfully validated LC/MS/MS methods for the matrices. The methods were validated in compliance with the FDA and Crystal City Guidelines, at the client desired limits of quantitation and a formal validation report was prepared and submitted to the client. Upon completion of validation, multiple samples of each matrix were analyzed, including approximately 10% sample reanalysis for incurred sample reproducibility. A formal sample analysis report was prepared and submitted to the client.

More Than Just Human Samples

A client required a rapid PK screening method for a drug compound and its three metabolites in canine and equine plasma samples. Cyanta's scientists qualified a method for the analysis of the drug compound and its metabolites in both canine and equine plasma samples with a limit of quantitation of 1 ng/mL for the drug compound and the primary metabolite and 10 ng/mL for the other two metabolites. Plasma samples from both the canine and equine studies were submitted and analyzed. Results with statistical analysis of the PK data for both the canine and equine study samples were reported to the client within 72 hours of sample receipt.

Rapid Development, Testing and Turnaround

A client required a rapid PK screening method for a drug compound in rat plasma. Cyanta's scientists qualified a method for the analysis of the compound at a limit of quantitation of 0.1 ng/mL. Rat plasma samples were submitted and analyzed. Results with statistical analysis of the PK data were reported to the client within 48 hours of sample receipt.