Central Lab Capabilities
Anatomic Pathology
PPD™ Laboratory services’ central lab provides molecular anatomic pathology and specialty testing for drug discovery, companion diagnostics (CDx) and in vitro diagnostics (IVD) validation studies to support oncology. Our central lab has a broad range of capabilities in anatomic pathology supported by immunohistochemistry (IHC), chromogenic in situ hybridization, and molecular studies. Additionally, we work with specialized partners to complement and extend our service offering. Multispecialty pathologists have been chosen based upon their technical expertise to cover virtually all major therapeutic areas. Specimens are digitized and are available to pathologists in real time via a secure web-based portal. We provide sample interpretive reporting, customized to meet client requirements.
Our Anatomic Pathology service offering includes:
- Histological services
- Grossing, embedding and microtomy
- Hematoylin and Eosin (H&E), special stains and IHC stains
- Digitization of prepared specimens
- Sample interpretive reporting customized to meet customer requirements
Key instrumentation platform categories:
Grossing and processing
- Sakura Tissue-Tek® Cassette Printer
- Mopec® Grossing Hood
- Leica® ASP300S Tissue processor
- Leica® Pegasus Tissue processor
- Leica® ASP6025S Tissue processor (SG)
Trimming and embedding
- Thermo Scientific™ HistoStar™ Embedding Workstation
- Premiere® Wax Trimmer XH-90
Cytology processing and staining
- Hologic ThinPrep 5000 Processor
- Eppendorf Centrifuge
Microtomy
- Leica® RM2245 Microtome
- Leica® Histocore Multicut Microtome
- Leica® RM2125 RTS Microtome
- Premier® Tissue Floating Bath
- Premier® Lighted Tissue Floating Bath
Multistaining (Leica® ST5020 Multistainer)
- Hematoxylin and Eosin (H&E) Stain
- Special stains: Periodic Acid Schiff (PAS), Alcian Blue-PAS, PAS-Diastase, Picro-Sirius Red (PSR), and Masson’s Trichrome
- Non-gynecological Papanicolaou (PAP) stain
Curl to vial microtomy & macrodissection
Digitization of prepared specimens
- Aperio® AT2 Digital pathology scanner
Autoimmune, inflammatory and allergy testing
In addition to specific IgE blood testing, we offer plasma protein determination utilizing the BN™ II System from Siemens Healthcare and Cobas from Roche. These systems use nephelometry to analyze plasma proteins and supports the clinical management of a variety of disease states such as inflammation, gammopathies, cardiovascular risk, rheumatoid diseases and others. PPD Laboratory services has been using the BN II System to provide IgA, IgE, IgG, and IgM detection and analysis for more than 10 years.
Some pharmaceutical development studies may also benefit from the analysis of interleukins (IL) as markers for immune response and inflammation. PPD Laboratory services has validated ELISA assays for IL1, 2, 4, 5, 6, 7, 8, 10, 12, 12p70, 13, 17, 18, 21, 22 and 23. Most of these protocols 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.
Our central lab service offering includes:
- Rheumatoid factor
- Free light chains
- Autoantibodies
- Antinuclear antibodies (ANA)
- Interleukins
- Interferon
- Serum IgE
- Complement
Key instrumentation
- Thermo Scientific Phadia® 1000
- Siemens Healthcare BN™ II
- DiaSorin Liaison XL
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.
PPD Laboratory services 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 our global lab network and enables us to use a tiered regulatory approach to customize biomarker solutions for our customers.
Our central lab performs cell-based assays and flow cytometry under good clinical laboratory practice (GCLP) and/or clinical laboratory improvement amendment (CLIA) regulations. Our 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.
Our central lab service offering includes:
- Peripheral blood mononuclear cells (PBMCs)
- Cell enumeration
- Immune response
- Cell service assays
- T-reg assays
- TBNK Panel
- CD 3, 4, 8, 25, 19, 20, 39, 127, etc.
- Myeloid derived suppressor cells (MDSC)
Flow cytometry global instrumentation
- Immunophenotyping
- Panel development
- Testing validation services
- Cell sorting / PBMC enrichment
- Aliquoting services
Key instruments:
- BD FACSLyric
- BD FACSDuet
- BD FACSCanto™ II
Chemistry and immunoassays
Our central lab offers an extensive menu of traditional chemistry and immunoassays to support safety testing for all phases of pharmaceutical development. Our leading global labs are highly automated and can manage trials of any size.
Our central lab service offering includes:
- Bone markers
- Diabetes
- Drugs of abuse
- Toxicology
- Oncology
- Endocrinology
- Cardiac markers
- Routine chemistry
- Liver function
- Infectious diseases
Key instrumentation:
- Roche Cobas® 6000 and 8000
- ADVIA Centaur XP Immunoassay System
- DiaSorin Liason® XL
Chromatography and mass spectroscopy
Our central lab offers a variety of chromatography and mass spectroscopy-based assays to support Phase II-IV studies. Our advanced instrumentation and our menu of assays continues to grow to meet project needs.
Our central lab service offering includes:
- Amino acids
- Bone markers (vitamin D)
- Nutritional (vitamins)
- Diabetes (hemaglobin A1C)
Key instrumentation:
- Waters Acquity
- Sciex 4000™, 5000™, 6500™ triple quadrapoles
- Waters Xevo®
- 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.
Our central lab solutions include:
- RNA/DNA (extraction, quantification, concentration, purity determination)
- Infectious diseases (HBV, HCV and HIV viral load)
In order to look at the mutational landscape to refine risk prediction and inform adjuvant treatment decisions, our central lab offers profiling of tumor and plasma samples by various Oncomine assays on Thermo Fisher Scientific’s Genexus Platform. These assays will be validated under CAP/CLIA regulatory guidelines (in June 2024) to enroll stratified patients in clinical trials, and will be used for exploratory studies to learn about tumor heterogeneity and identify drug resistance mechanisms.
Key instrumentation:
- Applied Biosystems® 3500 XL
- Applied Biosystems® 7500 Fast Dx and QuantStudio™ Dx
- QuantStudio 12K Flex Real Time PCR System
- KingFisher™ Flex Purification System
- Illumina MiSeq Dx
- BioFire® Respiratory (RP2.1) Panel
- Abbott m2000 RealTime System
- Abbott Alinity m System
- Roche cobas® Ampliprep/Taqman®
- Roche cobas® 4800 System
- Roche cobas® 6800 System
- Roche Lightcycler 2.0
- Qiagen QIAsypmphony
- Quidel® Solana®
- Thermo Scientific NanoDrop™ 2000
- Thermo Scientific NanoDrop™ 8000
Hematology and coagulation
Our flexible hematology and coagulation laboratory provides routine as well as study-specific testing options, analyzing the patient’s blood for abnormalities in red blood cells, white blood cells and platelets. Studies can include automated differentials or manual differentials from prepared peripheral blood smears. We offer diabetes monitoring of HbA1c via gold standard, high-performance liquid chromatography (HPLC) methodology. HPLC gives accurate 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.
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
- Sysmex-XN-2000
- Tosoh G8 HPLC
Microbiology
Our central lab microbiology department offers a variety of bacteriology testing with the capabilities and experience to meet various study requirements and to support testing for all phases of pharmaceutical development. We have CO2 incubators for ambient (room) air, and for high temperatures. The microbiology lab is open 7 days a week, with 365 day coverage.
Our microbiology lab service offering includes:
- Bacteriology
- Candida screening
Key instrumentation:
- Bruker MALDI-TOF
- Sensititre Vizion system
Protein analysis
Our central lab offers a broad menu of protein analysis testing and ensures excellent accuracy and precision. Our exceptional global laboratories are highly automated and can manage trials of any size while preserving data integrity.
Our central lab service offering includes:
- Lipoproteins
- C-reactive protein
- HDL, LDL, VLDL and ratios
- Triglycerides
- Protein electrophoresis
Key instrumentation
- Roche Cobas® 8000
Urinalysis
We provide safety assessments across a wide range of services, including urinalysis. We offer quality chemistry dipstick testing and automated microscopic evaluations of patient urines with reflex to manual microscopic evaluation if needed.
This includes:
- Automated particle recognition (casts, crystals, cells, etc.)
- Dipstick testing (ketone, protein, bilirubin, etc.)
Key instrumentation:
- Iris® iQ200™ and iChem® Velocity™
Related resources
Learn more about PPD Laboratory services central lab capabilities.
