clinical bioanalysis 

You need a partner that provides comprehensive bioanalytical support for all stages of product development, from early discovery to preclinical studies and all phases of clinical development. Our scientists have extensive experience in developing, validating and applying quantitative methods for the determination of pharmaceutical compounds and their metabolites in biological samples, from small molecules to larger peptides. Methods can be transferred from sponsor laboratories and feasibility studies performed to confirm suitability for purpose. All work is conducted to GLP standards and current regulatory guidelines.

We continually invest in the area of bioanalysis to increase our capabilities to conduct sensitive and specific sample analysis. Our laboratories have the latest analytical equipment to measure drug and metabolite concentrations in biological matrices such as plasma, serum, CSF, urine and tissues using a wide range of different techniques. Our bioanalytical scientists use 96-well-plate automated sample extraction and high-throughput microcolumn analysis to rapidly analyze sample batches of varying sizes at an industry-leading pace. All biological studies are supported by a validated Watson™ laboratory information management systems (LIMS) for sample and data management. This automated system brings a number of benefits, the most significant being improved efficiency in the collation and reporting of data.

Analytical Methodologies 

• LC-MS/MS
• LC-MS, GC-MS
• HPLC, GC
• CE
• Immunoassay techniques such as ELISA, RIA, EIA, IRMA and DELFIA
• AAS for measurement of total metal content in biological samples

 

To assist in quantitative bioanalysis, our chemical synthesis group can produce non-labeled or stable isotope labeled compounds, such as deuterated or ¹³C analogues, for use as assay internal standards. They can also assist with metabolite identification, profiling and synthesis.