Your Global Drug Development Organization for Bioanalysis Testing
With over 30 years of experience and operating out of our GLP/GCP compliant laboratories, SGS has the expertise to both develop assays from scratch (including LC-MS/MS, immunoassays and cell-based assays) and to support from small to large scale routine sample analyses, from regulatory pre-clinical (toxicology) to early and late clinical studies (Phase I to IV) with high quality data.
SGS Life Sciences provides bioanalytical testing services for drug development from regulatory preclinical to early and late clinical phases to cover:
- Pharmacokinetics (small molecules, biologics, biosimilars)
- Biomarkers (PD) (soluble and cellular biomarkers)
- Immunogenicity (screening, confirmatory, titration characterisation and neutralising anti-drug antibody assays)
- Method transfer, development and validation for small molecules, biologics, biosimilars and biomarkers
- ELISA and multiplex assays for biomarkers
- Cell-based assays (cellular biomarkers, receptor occupancy, neutralising anti-drug antibody assays, immunophenotyping)
- Hybrid approach LBA/LC-MS/MS
- Discovery Services (i.e. Immunotox, non-regulatory preclinical studies)
To support the bioanalysis of various classes of compounds, a large range of techniques and methods are available to you with the state-of-the-art platforms. Also, an exceptional sample processing and analytical capabilities, combined with scientific expertise, enables us to provide rapid and high-throughput bioanalysis.
SGS also supports the development of different types of Biologics (i.e. Monoclonal Antibodies, Bispecific, Trispecific, ADC, Biosimilars, etc…) by setting up from scratch Pharmacokinetics, Immunogenicity (full workflow: Screening, Confirmatory, Titration) and Neutralizing Anti-Drug Antibodies assays.
Trusted pharmaceutical method development, method validation and pre-clinical and clinical samples assays services from a world-leading provider.
Our extensive experience in the development of new chemical entities (NCE), bioanalytical methods and our state-of-the-art instrumentation have allowed us to achieve:
- Extremely low LLOQ
- Low sample volume
- Large dynamic ranges
- Quantification of multiple metabolites
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.
SGS has the expertise to both develop assays from scratch (including LC-MS/MS, immunoassays and cell-based assays) and to support large scale routine sample analyses, from regulatory pre-clinical (toxicology) to early and late clinical studies (Phase I to IV). The variety of platforms (i.e. MSD, Luminex, ELLA, Flow cytometer, etc…) available allows SGS to select the appropriate platform to a dedicated project. In parallel, SGS has validated several multiplex inflammatory panels (cytokines/chemokines) in human matrices, methods readily available for clinical sample analysis.
Whether for testing efficacy or safety of drugs in development, our biomarker bioanalytical services cover a range of therapeutic areas to include:
- Central nervous system (CNS)
- Metabolic disorders
- Thyroid disease
- Sexual health
- Bone disease
- Allergy and respiratory
All work is conducted to GLP/GCP standards and current regulatory guidelines (i.e. FDA, EMA).
SGS is the world’s leading inspection, verification, testing and certification company.
We help bio/pharmaceutical and medical device companies by providing services along the entire drug development pathway. We offer a comprehensive range of integrated solutions, including preclinical activities, Phase I-IV clinical trials, bioanalytical, pharmaceutical development, biologics characterization, biosafety, and quality control testing of small and large molecules, raw materials, containers, and finished products.