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Biomarker Lab Capabilities

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
Learn more about the cell-based assay capabilities of the PPD Laboratories' Central Lab

Ligand-binding assays

PPD Laboratories’ 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

Immunohistochemistry

Our biomarker lab leverages PPD Laboratories’ strategic alliance with NeoGenomics for immunohistochemistry (IHC) services.

Learn more about the anatomic pathology and immunochemistry capabilities of the PPD Laboratories' Central Lab

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 quadrapoles, 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 Laboratories 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)

Related resources

Learn more about PPD Laboratories’ biomarker lab capabilities.