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Bioanalytical Lab Capabilities


Cell-based Assays

Cell-based assays represent a key platform utilized for various applications, such as drug safety assessment, needed as part of immunogenicity studies. PPD® Laboratories’ bioanalytical lab has been providing cell-based assays services since 2007.

The bioanalytical lab has a dedicated team of research scientists experienced in cell culture technologies, cell-based assay development and validation, cell-line engineering, microbiology, virology and molecular biology.

The bioanalytical lab’s cell-based assay experience involves the transfer of more than 80 cell-based assays across a wide range of applications including:

  • Drug-specific NAb assays (including biosimilars)
  • Biomarkers
  • Toxin neutralization assay (TNA)
  • Virus-specific NAb assays

Our service offering includes:

  • Comprehensive assay transfer capabilities
  • CLIA validation of NAb assays
  • Sample analysis for studies in excess of 1,500 samples
  • Various end points for early events, for example receptor phosphorylation (ECL), cellular proliferation (cATP, cAMP) and cell signaling pathways (STAT3,SMAD)
  • Numerous end points for late events consists of cytokine production/detection and reporter gene products (fluorescence)

Key instrumentation:

  • MSD® Sector® S 600 reader
  • BioTek Cytation reader
  • Beckman Coulter Vi-CELL analyzer
  • Biosafety cabinets
  • CO2 incubators

In addition to supporting bioanalytical studies for various types of pharmaceuticals, cell-based assays are an integral part of vaccine development.

Learn more about PPD Laboratories’ vaccine development capabilities.

Chromatography/Mass Spectrometry

PPD® Laboratories’ bioanalytical lab offers substantial capacity and expertise in the increasingly sophisticated field of chromatography. We have applied LC-MS/MS to compounds that range from small molecules to antibody-drug conjugates (ADCs) with measurement in biological fluids and tissues. We utilize the most advanced automated sample cleanup techniques for rapid sample analysis and employ stable isotope internal standards for highly precise quantitation. Our extensive scientific and technical expertise includes:

  • Highly diverse range of analytes from small molecules to complex biologics
  • Difficult endogenous, reactive or unstable analytes
  • Ultrahigh sensitivity assays with sub-pg/ml lower limits of quantification (LLOQ)
  • High-resolution mass spectrometry

Key instrumentation:

  • Hamilton® MICROLAB® STARlet automatic pipetting workstation
  • Sciex Triple Quad 6500
  • Sciex Q-Traps
  • Shimadzu Nexera UHPLC systems with 2-D capabilities
  • Thermo Scientific Q Exactive Plus (HRMS)
  • Thermo Scientific Aria® multiplexing systems
  • Waters Xevo® G2 QTof (HRMS)
  • Waters Acquity UHPLC systems with 2-D capabilities

Learn more about PPD Laboratories’ biologics experience.

Learn more about PPD Laboratories’ small molecule experience.

Flow Cytometry

PPD® Laboratories’ flow cytometry assays integrate into our bioanalytical and central labs. This integration provides flexibility to leverage our operational and organizational structures for a tiered regulatory approach to meet clients’ needs.

From fit-for-purpose assays to projects that require GCLP-, GLP- or CLIA-compliant assays we have the technology platforms, the clinical expertise and the collaborative and flexible mindset needed to develop customized solutions for our clients.

We have a dedicated team of scientists at the bioanalytical lab and many cross-trained scientists across the various central lab locations. Research and development for flow cytometry assays is performed in our Richmond, Virginia, location, where our scientists have more than 25 years of combined experience.

Our service offering includes:

  • Assay development and validation under CAP/CLIA, GLP and/or GCLP regulations
  • Enumeration of cells (4-, 6- and 8-color)
  • Routine cell surface antigen expression
  • Intracellular cytokine assays
  • Platelet, neutrophil and basophil activation assays
  • Receptor occupancy
  • Complex phospho-flow assays
  • Peripheral mononuclear cell (PBMC) enumeration and intracellular cytokine assays
  • Training to clinical sites for complex procedures, such as phosph-flow and activation assay

Key instrumentation:

  • BD FACSCanto II flow cytometers

In addition to supporting bioanalytical studies for various types of pharmaceuticals, flow assays are an integral part of biomarker development.

Learn more about PPD Laboratories’ biomarker development capabilities.

Immunochemistry

PPD® Laboratories’ bioanalytical lab offers comprehensive immunochemistry services to support pharmacokinetic (PK) and anti-drug antibody (ADA) safety assessments. We have broad biopharmaceutical experience with a variety of molecules including monoclonal and multivalent antibodies, antibody fragments, oligonucleotides, PEGylated proteins and antibody drug conjugates (ADCs).

Our service offering includes:

  • PK/PD ligand-binding methods
  • Immunogenicity / ADA assays
  • Oligomer/aptamer methods
  • 40 plate-based neutralizing antibody assays
  • Quantitation and validation of endogenous analytes
  • Robotic liquid handling to support high-volume testing needs and improve precision and accuracy
  • Automated immunogenicity screening

Key instrumentation/platforms:

  • TECAN EVO® automated liquid-handling workstations
  • ELISA
  • Meso Scale Discovery® (MSD®) Technology
  • Gyros Gyrolab xP workstation
  • Fluorescence and radioimmunoassays

Learn more about PPD Laboratories’ biosimilar experience.

Molecular Genomics

PPD Laboratories has custom-built a spacious, cutting-edge molecular genomics suite staffed with a dedicated team of molecular biologists. The suite of labs is designed with the appropriate engineering and procedural controls to minimize the risk of reagent and sample contamination. Our capabilities include assay development, qualification, validation and sample analysis services in the following areas:

  • Viral detection, quantification and typing (PCR-based)
  • Bacterial detection, quantification and typing (PCR-based)
  • SNP detection
  • Copy number variation
  • Gene sequencing
  • Gene expression
  • Vector (transgene) copy number
  • Vector (transgene) persistence
  • Epigenetics

Key instrumentation:

  • Agilent Mx3005P qPCR System
  • Agilent TapeStation 2200 Bioanalyzer
  • Applied Biosystems® 3730xl Genetic Analyzer
  • Applied Biosystems 7500
  • Applied Biosystems QuantStudio 6
  • BioMérieux NucliSENS® easyMag® nucleic acid extraction system
  • BioRad Gel Doc XR+ Imaging System
  • BioRad QX200 Droplet Digital PCR (ddPCR) System
  • Illumina® MiSeq (NextGen sequencer)
  • Qiagen BioRobot Universal System
  • Qiagen QIAsymphony® SP nucleic acid extraction system
  • TECAN EVO® automated liquid-handling

Learn more about PPD Laboratories’ biomarker capabilities.

Learn about the experience and expertise of our bioanalytical lab

 

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