Biomarker Expertise and Capabilities
The journey from exploratory biomarker discovery to clinical application is complex, with decisions made along the way having significant implications for drug development timelines and costs.
From identifying clinically meaningful biomarkers and selecting the appropriate analytical platforms to developing fit-for-purpose assays that deliver accurate, reproducible data, every decision matters. Choosing the right approach early can help minimize risks, improve efficiency, and support informed decision-making throughout clinical development.
Our extensive technology portfolio and global laboratory network provide the flexibility to accommodate diverse study requirements and evolving biomarker strategies while maintaining high standards of quality and turnaround time.
Our experienced scientists work closely with sponsors to develop and validate fit-for-purpose assays that generate reliable, reproducible data, support regulatory expectations, and scale with evolving program needs.
From biomarker selection to assay development and validation, we help you generate meaningful, high-quality data to support confident decision-making at every stage of clinical development.
Flow cytometry and cell-based assays
PPD™ Laboratory Services’ biomarker lab has access to industry-leading instrumentation in both the bioanalytical and central labs. The biomarker lab can accommodate everything from research assays to fully validated assays with CAP/CLIA, GLP and GCLP compliance. The lab also provides training to clinical sites on proper sample processing for complex procedures, such as phospho-flow and activation assays. The biomarker lab has experience with various sample types including whole, frozen and lysed blood, as well as peripheral blood mononuclear cells (PBMCs). The test menu includes routine cell surface assays and intracellular assays.
Key instrumentation:
- BD FACSCanto™ II
- BD FASCLyric™
- CTL Immunospot Reader
- BD FACSCanto™ II
- BD FASCLyric™
- Cytek® Northern Lights
- CTL Immunospot Reader
Ligand-binding assays
PPD Laboratory services’ biomarker lab offers traditional ELISA, electrochemiluminescence and microfluidics-based ELISA. We work in consultation with customers to develop a tiered approach to validation depending on the needs of the program or phase of development of the biomarker.
Our biomarker experts are in close contact with the various lab locations to ensure integration and a smooth transition of assays and technology during development of the biomarker program.
Key instrumentation:
- Meso Scale Discovery® (MSD®) Technology
- ELISA – Molecular devices Spectramax
- Protein Simple Ella Simple Plex™ System
- Quanterix™ SiMoA HD-X Analyzer™
- SMCxPro – Single Molecule Counting
- Tecan Spark multimode reader (Abs/Lum/Flu)
- Bioplex 200
- Tecan EVO and Hamilton instruments
- ARGO® HT System, Alamar Biosciences, Inc.
- Olink™ Signature Q100
NULISA™ ultrasensitive biomarker analysis
The NULISA™ technology, paired with the ARGO® HT System from Alamar Biosciences, Inc., enables attomolar-level sensitivity and highly multiplexed protein analysis.
A proprietary sequential immunocomplex capture-and-release mechanism, combined with nucleic acid-based detection and Next-Generation Sequencing (NGS) readout, delivers high sensitivity across a broad dynamic range. This enables measurement of low- and high-abundance proteins across a wide range of concentrations, helping minimize the need for sample dilution.
Key benefits:
- Fully automated workflow with minimal hands-on time
- High-throughput processing of up to 288 samples per run batch
- Ready to use panels supporting immunology, inflammation, oncology, and neurology research applications
- Custom assay validation for PK and biomarker applications
- Relative NPQ and absolute quantification, depending on the NULISA assay
Olink® Platform. High-throughput, multiplex proteomics
The Olink platform supports large-scale biomarker discovery, targeted biomarker follow-up, and cohort-based translational research.
Powered by Proximity Extension Assay (PEA) technology with NGS- or qPCR-based readouts, the Olink portfolio enables sensitive, multiplexed protein analysis across discovery and targeted applications. Olink Explore HT provides broad proteome coverage with a 10-log dynamic range (fg/mL to mg/mL), while targeted solutions provide flexible panel design and absolute or relative quantification.
Key benefits:
- Flexible 5- to 30-plex panels selected from approximately 200 pre-validated assays with Olink Flex
- Customized targeted panels for biomarker follow-up with Olink Focus
- 5,000+ protein assay library to support development of focused protein signatures
- Absolute (pg/mL) and relative NPX quantification, depending on the Olink solution
Immunohistochemistry
Our biomarker lab leverages our strategic alliance with NeoGenomics for immunohistochemistry (IHC) services.
Liquid chromatography/mass spectrometry
The biomarker lab is equipped with exceptional liquid chromatography/mass spectrometry (LC-MS/MS) instrumentation to support biomarker method development and validation. Our experienced scientists, with knowledge of the current perspectives in biomarker assay validation, work with customers to develop a customized solution, which includes novel and routine biomarker assays. We maintain multiple LC-MS technologies, including triple quadrupoles, HPLC, UHPLC and multi-dimensional chromatography.
Key instrumentation:
- Sciex Triple Quad™ LC-MS systems – 6500+
- Shimadzu Nexera UHPLC systems with 2-D capabilities
- Hamilton® Nimbus automatic pipetting workstations
- Thermo Scientific™ UHPLC systems with 3-D capabilities
- Thermo Scientific™ Quantiva™ and Altis™ Triple Quadrupole Systems LC-MS systems
- Thermo Scientific™ Q Exactive™ Plus (HRMS)
Molecular genomics
PPD Laboratory services has a custom-built, spacious, leading-edge molecular genomics suite in Richmond, Virginia. The suite of labs is designed with the appropriate engineering and procedural controls to minimize the risk of reagent and sample contamination. It includes:
- Restricted access main entrance
- Central gowning laboratory that services the main suite
- Directional airflow and pressure control
- 100% exhaust biosafety cabinets
- Full (clean room style) gowning
- Whole room UV decontamination system
- Interlocked portals for transport of samples in and out of the room
- Industry-leading environmental monitoring system
Key instrumentation:
- Agilent TapeStation 4200 Bioanalyzer
- Applied Biosystems® 3500 and 3730xl Genetic Analyzer
- Applied Biosystems 7500 and Dx
- Applied Biosystems QuantStudio 6, 12 and Dx
- BioRad Gel Doc XR+ Imaging System
- BioRad QX200 Droplet Digital PCR (ddPCR™) System
- Illumina® MiSeq and MiSeqDx
- QiaCube HT
- Qiagen QIAsymphony® SP
- TECAN EVO®
- Kingfisher Flex
Our biomarker lab will offer profiling of tumor and plasma samples using Oncomine assays on Thermo Fisher Scientific’s Genexus Platform. The Oncomine assays can provide:
- CE-IVD option
- Multiplexed gene panels via automated workflow
- Analysis of solid FFPE tumors, liquid biopsies and hematological malignancies
- Only 10 ng of genomic material required for profiling
- Detection of mutations, copy number variants and fusion from same sequencing run with limit of detection down to 0.1%
- Ability to determine Tumor Mutational Burden (TMB)
Learn more about our biomarker capabilities
To request a proposal or contact your local business development representative, please complete the form below.