Bioanalytical Services
Global capabilities for every phase of clinical development and post-marketing
Syneos Health® Bioanalytical Services offers state-of-the-art bioanalytical technologies and deep scientific expertise supporting complex method development, validation and sample analysis. We routinely work with customers both large and small and will take a holistic approach to your project, no matter its size.
Our large molecule method development and production teams have over 15 years of experience with projects involving pharmacokinetic (PK), toxicokinetic (TK), pharmacodynamic and immunogenicity studies across a broad range of therapeutic modalities including:
- Monoclonal antibodies
- Biosimilars
- Antibody-drug conjugates
- Peptides
- Vaccines
- Cell and gene therapies … and many more
We also provide a comprehensive array of technical and logistical offerings, including:
- Ligand binding assays
- Cell-based assays
- Mass spectroscopy
- Critical reagent conjugations
- Biomarker analysis
- Sample management services
- Data transfer
- Reporting
- Study report services
All our Bioanalytical Services teams comply with the most current standards for Good Clinical Practices (GCP) and Good Laboratory Practices (GLP).
Connect with us to learn more about Bioanalytical Services at Syneos Health and how we can help.
Expertise
At a glance
- A top 3 global provider of bioanalytical services
- 2 GCP/GLP-compliant bioanalysis laboratories with robotics and LIMS, located in Princeton, New Jersey, USA and Quebec City, Canada
- 400 experts in complex method development, validation and sample analysis for large and small molecules, critical reagents characterization (LB), lab manuals and sample logistics
- GLP-certified since 2011
30+
years of experience
1,200+
validated assays
~200
new methods evaluated every year
More than 500,000
samples analyzed per year
Step inside our Quebec City Bioanalysis Lab
Explore our Bioanalytical Laboratory Services
Mass Spectrometry Analytical Services
Services
- Method development and validation: PK/TK, PD/biomarkers, element analysis
- Method development: from assay transfers to full development
- Full regulatory compliant method validation
- Fit-for-purpose validation/qualification
- Sample analysis
- Determination of protein-binding
- Exploratory metabolite profiling
Compounds
- Small molecule therapeutic agents
- Peptides
- Oligonucleotides
- Individual elements (by ICP-MS)
Niche Expertise
- Hybrid assays
- Large molecule analysis by LC-MS/MS
- Element analysis by ICP-MS
- Protein binding determination
- Encapsulated vs. non-encapsulated drug concentrations
- Endogenous molecules/biomarkers
- Ultra-sensitive analysis (<1pg/mL)
Technology Platforms
- LC-MS/MS; Sciex 7500, API6500+, 5000/4000
- LC-MS/MS; Waters Xevo-TQS
- High-Resolution Mass Spectrometers
- ICP-MS
- Hamilton Robotics
Ligand-Binding Assays
Services
- Method development and validation (PK/TK, immunogenicity, CBA/Nab testing)
- Full method development
- Method transfers
- Adaptation of commercial kits for regulated and non-regulated bioanalysis
- Sample analysis
Modalities
- Proteins
- Peptides
- mAb (monoclonal antibody)
- Fusion proteins
- Antibody conjugates
- Oligonucleotides
- AAV Gene Therapy
- Cell therapy
Technology Platforms
- MesoScale Discovery S600 ECLA
- SpectraMax® M5 multi-mode microplate reader
- SpectraMax® Plus384
- Perkin-Elmer EnVision microplate reader
- Hamilton Robotics
Analytical Techniques
- Electrochemiluminescence
- ELISA
- Cell-based assays
Biomarkers
Bioanalytical Services
Based on the context of use:
- Adaptation of commercial kits
- Custom assay development
- Method transfers
- Tiered approach to context of use assay validation
- Targeted and untargeted analysis
- Data analysis and interpretation
Analytical Techniques
- Immunoassays (various sensitivities, multiplexing and throughputs)
- LC-MS/MS
- Hamilton / Perkin Elmer Robotics
- Flow Cytometry
- Genomics/transcriptomics
- Proteomics
- Metabolomics/lipidomics
Technology Platforms
- Flow cytometry (Attunes NXT)
- RT-qPCR (QuantStudio 12k flex)
- SpectraMax® M5 multi-mode microplate reader
- SpectraMax® Plus384
- MesoScale Discovery SECTOR® S600
- Luminex (Bioplex 200)
- Perkin Elmer Envision
- OrbiTrap
- LC-MS/MS
- Bio-layer Interferometry
Data Output
- Qualitative
- Quasi-quantitative
- Relative quantitative
- Quantitative (absolute)
Critical Reagent and Characterization (CRC)
- Provide characterization of critical reagents to ensure stability and robust assay performance
- Perform bulk chemical conjugations of critical reagents for use in various assay platforms minimizing lot differences
- Inventory critical reagents and dispense upon request
- Comprehensive and transparent management of custom-made reagents starting from reagent request to inventory to finished material
