Pharmacokinetic Testing

With over 25 years of experience and operating out of three GLP compliant laboratories, SGS’s Life Science Services provides pharmacokinetic analysis and bioanalytical services with a dedicated team of specialists.

Pharma and biotech companies of all sizes have chosen us as the preferred bioanalytical partner. SGS has the expertise to both develop assays de novo (including immunoassays) and to support large scale routine sample analyses, from pre-clinical to clinical studies.

In order to support the bioanalysis of various classes of compounds (including peptides), SGS offers a large range of techniques and methods providing rapid high volume bioanalysis. Our method development processes focus on high-throughput technological capabilities (e.g. TurboFlow extraction, multiprobe robots).

SGS offers more than 700 validated bioanalysis methods that are ready for use with a very short lead-time. Validation criteria follow guidelines from the FDA (May 2001) and the Crystal City Conference (May 2006). All validations are tailored to specific program requirements.

Dried Blood Spot Analysis

Dry Blood Spot (DBS) technology has several advantages for toxicokinetic (TK) and pharmacokinetic (PK) analysis, including: reduced blood sampling collection, absence of post-collection processing, low biohazard risk, fewer required facilities for sample shipment and storage. Furthermore, sample analysis can also be simplified.

Early to Late Phase Clinical Trials and Post-Marketing

To support the bioanalysis of various classes of compounds, a large range of techniques and methods are available to you. Also, an exceptional sample processing and analytical capabilities, combined with scientific expertise, enables us to provide rapid, high-volume bioanalysis:

Mass Spectrometry
- 29 LC-MS/MS, 5 GC-MS
Immunoanalysis
- Singleplexed Custom Immunoassay Development
  - EIA’s
  - Radioimmunoassay (RIA)
  - Biomarker assay development and validation
- Multiplexed Custom Immunoassays
  - BD Beads array and quantification by BD FACSCanto II + High Throughput Sampler for 96- and 384-well microtiter plate capacity driven by BD FACSDIVA software, fully validated according to 21 CFR Part 11 rules
  - Biomarker assay development and validation
Classical HPLC
- 6 HPLC systems equipped with UV, fluorescence and electrochemical detectors
Automated sample preparation using robotics (multiprobe) or turbulent flow technology (cohesive)
Large sample storage capacity combined with excellent sample tracking (400,000 sample storage and equivalent backup)
Current throughput of more than 200,000 incurred samples per year
Sample handling and tracking by the Watson LIMS