Bioanalysis Services
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)
REDUCE COSTS, INCREASE EFFICIENCIES AND IMPROVE DEVELOPMENT PIPELINES
Discover the full range of our bioanalysis services
DOWNLOAD BROCHUREPharmacokinetic Testing for Small and Large Molecules
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.
Large Molecules
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.
New Chemical Entities (NCE)
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.
Biomarkers
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:
- Cardiovascular
- Central nervous system (CNS)
- Metabolic disorders
- Inflammation
- Thyroid disease
- Oncology
- Sexual health
- Bone disease
- Allergy and respiratory
All work is conducted to GLP/GCP standards and current regulatory guidelines (i.e. FDA, EMA).
Why Choose SGS?
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.
