Summary

Bioanalysis, Biomarker and Flow Cytometry Assay List.

GLP–Compliant Bioanalytical Laboratories

PRA maintains two modern bioanalytical laboratories in Lenexa, Kansas, USA and Assen, Netherlands. Their strategic locations near our early phase Clinical Research Units (CRUs) allow time-critical and limited stability samples to be analyzed quickly. The laboratories both conduct bioanalysis of small molecules, biologics and biomarkers for pre-clinical and Phase I-IV human clinical studies. They are fully harmonized operations and adhere to the same stringent global regulatory guidelines including GLP compliance.

These facilities provide the ideal environment for complex bioanalytical services, including standalone projects, those combined with an early phase trials in one of PRA’s CRUs, and those conducted in conjunction with PRA’s Product Registration Services division. Both laboratories are equipped with the latest technologies and infrastructure, as required by pharmaceutical and biotechnology companies.

Our bioanalytical laboratory services include:

• Pharmacokinetic bioanalysis of small molecules and biologics

• Immunogenicity analysis and cell-based neutralizing antibody measurements (Nab)

• Biomarker Analysis

• Flow Cytometry Analysis

• Biochemistry (stimulation assays, enzymatic activity)

• GMP Quality Control

• Radioisotope Analysis

• Global Supply Logistics

• Biomarker Strategic Consultation

Utilizing the following technologies and facilities:

• Sciex LC/MS/MS, Agilent and Waters UPLC systems.

• ELISA, MSD ECLIA, EMD Singulex Erenna, ProteinSimple ELLA.

• FACSCanto 8 Color, Fortessa 18 Color Flow Cytometers and Glomax Luminescence plate reader.

• Hamilton and Tomtec Robotic Automation.

• Radioisotope analysis laboratory, with a permanent license for the analysis of radiolabeled compounds (14C, 3H).

• Biohazard laboratory with a Biosafety Level II license (microbiological laboratory Class II [ML-II]), qualified to handle potentially infected samples.

• Co-located Phase 1 Clinics at both laboratories.


Full-Service Clinical Laboratory

PRA also offers clinical chemistry services in a fully equipped, dedicated laboratory. Our clinical laboratory has supported more than 3000 clinical studies over 30 years, and can typically report data within 8 hours after sample receipt. For immediate safety analysis, turnaround times of 1 hour are feasible. All analyzers are bi-directionally linked with an intelligent laboratory information system, enabling fully automated, barcode-driven analysis and reporting of results.

Our Clinical Laboratory services include:

• Hematology, including automated differentiation

• Coagulation parameters

• Immunology, using both fully automated analyzers and semi-automated ELISA equipment

• Urinalysis, fully automated for screening and microscopy analysis

• Capabilities of LPS Challenge stimulation, PBMC-isolation techniques and Platelet Aggregation analysis

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Bioanalysis, Biomarker and Flow Cytometry Assay List

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