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Central Lab Capabilities


Anatomic Pathology

PPD® Laboratories’ anatomic pathology scientists have more than 60 years of combined experience in anatomic pathology services and research. We continuously add new immunohistochemistry (IHC) and special stains to our offerings in response to project and client needs. All specimens are digitized into our Aperio database and are available to pathologists in real time via a secure web-based portal. We work with multispecialty pathologists who have been chosen based upon their technical expertise to cover all major therapeutic areas.

Anatomic Pathology Our central lab service offering includes:

  • Histological services
  • Grossing, embedding, microtomy
  • Immunohistochemistry (IHC)
  • Hematoxylin and Eosin(H&E), special stains and IHC stains
  • Digitization of prepared specimens
  • Sample interpretive reporting customized to meet client requirements

Key instrumentation:

  • Thermo Scientific HistoStar Embedding Workstation
  • Leica® RM2245 Microtome
  • Leica® ST5020 Multistainer
  • Ventana® BenchMark ULTRA
  • Aperio® AT2 Digital pathology scanner

Autoimmune, Inflammatory and Allergy Testing

PPD® Laboratories’ central lab offers a complete menu of autoimmune, inflammatory and allergy testing, including high throughput of specific IgE blood (sIgE) testing, plasma protein determination and analysis of interleukins (IL). We have validated ELISA assays for more than 15 ILs; many of which are multiplex assays that can save time and control costs. We have more than eight years of experience developing and validating IL assays and can develop and validate custom assays for the ILs that are important to your study.

Autoimmune, Inflammatory and Allergy Testing

Our central lab service offering includes:

  • Rheumatoid factor
  • Free light chains
  • Autoantibodies
  • Antinuclear antibodies (ANA)
  • Complement
  • Interleukins
  • Interferon
  • Serum IgE

Key instrumentation:

  • Thermo Scientific Phadia® 1000
  • Siemens Healthcare BN II
  • Beckman Coulter Access 2
  • DiaSorin Liaison

Biostorage

Sample stability and storage have become paramount, allowing companies to access previously collected samples for new and innovative compounds or to identify genetic markers.

Biostorage

PPD Laboratories keeps pace with the needs of the industry and offers:

  • Biorepository services and sample management consulting
  • On-site sample preparation to ensure sample integrity
  • Liquid nitrogen storage (-190 degrees Celsius)
  • -70 degrees Celsius storage in purpose-built freezer facility
  • Cold storage (-20 to 5 degrees Celsius)
  • Controlled room temperature (15 to 27 degrees Celsius )
  • Specialty storage services for peripheral blood mononuclear cells (PBMCs)

Our standard biorepository services include:

  • 24-hour security with limited staff access
  • 24-hour worldwide remote monitoring capabilities
  • Complete power backup system
  • Complete access to sample data and specialized reports

Cell-based Assays and Flow Cytometry

Our flow cytometry services are integrated into both the bioanalytical and central labs. This integration provides flexibility, leverages the broad experience of PPD Laboratories and enables us to use a tiered regulatory approach to customize biomarker solutions for our clients.

PPD Laboratories’ central lab performs cell-based assays and flow cytometry under good clinical laboratory practice (GCLP) and/or clinical laboratory improvement amendment (CLIA) regulations. Our central lab test menu includes both routine cell surface assays as well as intracellular assays. We have capability for four-, six- and eight-color analysis depending upon the needs of the assay.

Cell-based Assays and Flow Cytometry

Our central lab service offering includes:

Key instrumentation:

  • BD FACSCanto

Chemistry and Immunoassays

PPD Laboratories’ central lab offers a complete menu of traditional chemistry and immunoassays to support safety testing for all phases of pharmaceutical development. Our state-of-the-art laboratories are highly automated and can manage global trials of any size.

Chemistry and Immunoassays

Our central lab service offering includes:

  • Bone markers
  • Cardiac markers
  • Diabetes
  • Drugs of abuse
  • Toxicology
  • Oncology
  • Endocrinology
  • Routine chemistry
  • Metabolic
  • Liver function
  • Infectious diseases

Key instrumentation:

  • Roche Cobas® 8000
  • Beckman Coulter Access
  • DiaSorin Liaison®

Chromatography and Mass Spectroscopy

PPD Laboratories’ central lab offers a variety of chromatography and mass spectroscopy based assays to support Phase II-IV studies. Our instrumentation is cutting edge and our menu of assays continues to grow to meet project needs.

Chromatography and Mass Spectroscopy

Our central lab service offering includes:

  • Amino acids
  • Bone markers (vitamin D)
  • Nutritional (vitamins)
  • Diabetes (hemoglobin A1C)

Key instrumentation:

  • Waters Acquity
  • Waters Xevo®
  • Sciex 4000, 5000, 6500 triple quadrapoles
  • Agilent 5975 Turbo System GCMS
  • Tosoh G8 HPLC Analyzer

Genomics and Molecular Assays

Our molecular capabilities include RNA and DNA purification and commonly used viral assays such as hepatitis B virus (HBV), hepatitis C virus (HCV) and HIV viral load. The central lab works closely with our bioanalytical lab to support studies that require genomics, advanced molecular assays or the development of companion diagnostics.

Genomics and Molecular Assays

Our central lab service offering includes:

  • RNA/DNA (extraction, quantitation, concentration, purity determination)
  • Infectious diseases (HBV, HCV and HIV viral load)

Key instrumentation:

  • Roche MagNA Pure LC 2.0
  • Roche Cobas® Ampliprep
  • Roche Taqman®
  • Lightcycler 2.0
  • Abbott Molecular m2000 RealTime System
  • bioMérieux NucliSENS® easyMag®

Hematology and Coagulation

Our hematology and coagulation laboratory is a full-service department with study-specific options. Studies can choose to have an automated differential or send peripheral blood smears for manual differentials. Hematology offers diabetes monitoring of HbA1c via gold standard, high-performance liquid chromatography (HPLC) methodology. HPLC gives exact results without interference from other hemoglobin fractions. The coagulation lab offers basic clotting time studies, factor evaluations, D-dimer, protein C and protein S assays.

Hematology and Coagulation

Our central lab service offering includes:

  • Clotting time studies
  • Factor evaluations
  • D-dimer
  • Protein S and C activity
  • CBC and differential
  • Manual differential
  • HgbA1c testing

Key instrumentation:

  • IL ACL Top® 500
  • Beckman Coulter® LH 750
  • Tosoh G8 HPLC

Microbiology

Our central lab microbiology department offers a complete menu of bacteriology testing with the capabilities and experience to meet various study requirements and to support testing for all phases of pharmaceutical development.

Microbiology

Our central lab service offering includes:

  • Bacteriology
  • Candida screening

Key instrumentation:

  • Beckman Coulter MicroScan Walkaway Plus
  • Dupont RiboPrinter

Protein Analysis

PPD Laboratories’ central lab offers a complete menu of protein analysis testing and ensures excellent accuracy and precision. Our state-of-the-art laboratories are highly automated and can manage global trials of any size while preserving data integrity.

Protein analysis

Our central lab service offering includes:

  • Lipoproteins
  • C-reactive protein
  • HDL, LDL, VLDL and ratios
  • Triglycerides
  • Protein electrophoresis

Key instrumentation:

  • Roche Cobas® 8000

Urinalysis

The PPD Laboratories’ central lab offers quality chemistry dipstick testing and automated microscopic evaluations of patient urines with reflex to manual microscopic evaluation if needed.

Urinalysis capabilities

Our central lab service offering includes:

  • Automated particle recognition (casts, crystals, cells, etc.)
  • Dipstick testing (ketone, protein, bilirubin, etc.)

Key instrumentation:

  • Iris® iQ200 and iChem® Velocity
  • Siemens CLINITEK Atlas®

 

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