Bioanalytical Services
The Bioanalytical Services Department offers scientific excellence, uncompromised quality and unbeatable timelines to meet and exceed client needs.
Our GLP-compliant bioanalytical Canadian facility, located in Laval (Quebec, Canada), is 20,000 sq feet (1850 sq metres), with 24 LC-MS/MS systems (19 API3000 & 5 API5000 operating 24/7), 5 LC-MS, 9 UV detectors and 5 fluorescence detectors. It is fully equipped with a dedicated method development group and multiple state-of-the-art equipment, ensuring a straightforward and compliant submission for any country.
Simbec Laboratories are located in Merthyr Tydfil, Wales, UK and have been providing bioanalytical support for nearly 35 years. Our GLP-compliant bioanalytical UK facility is 10,000 sq feet (925 sq metres), with 5 LC-MS/MS instruments and 2 LC-MS instruments in operation as well as GC-MS.
Biomarker assays using enzyme- (ELISA) and radioimmunoassay (RIA) techniques are also an increasingly important area of work. We have a Radioisotopes laboratory which performs radioactivity measurements for human ADME and Mass Balance studies. Radio-HPLC and MS-MS techniques are used to investigate metabolite profiles and to assist the identification of putative metabolites.
Combined, our bioanalytical facilities share more than 500 validated methods for drugs, metabolites and biomarkers in biological matrices, covering most therapeutic areas.
Our expertise, combined with our state-of-the-art instrumentation, allows us to achieve:
- Extremely low LLOQ
- Large dynamic ranges
- Analysis of multiple metabolites
- Analysis from various matrices and species
- Quick method development of high throughput assays using strict criteria
- Successful method transfer or adaptation
We are also working on methods using new and/or high throughput technologies, such as Dried Blood Spots (DBS) analysis. Through our expertise we can overcome challenges like potential stability issues and matrix effects. One of our major focuses is to develop rugged methods that are free of interference from metabolites.
We perform assays on almost 400,000 samples per year, many for multiple analytes and comprising parent drug and several metabolites in one single assay. Sample analysis is performed for projects carried out in our own clinics as well as for external projects (from preclinical to Phase I-IV).
