Bioanalytical Laboratory

PRA utilizes the Watson LIMS system to support all laboratory systems and to accelerate report delivery.

Our Specializations

PRA's laboratory specializes in:

• Development, implementation and validation of assay methods
• Bioanalysis of samples from clinical and preclinical studies, conducted either in our own clinical research center or client study centers
• Bioanalytical protocol design and writing
• Preparation of bioanalytical reports to standard templates or as specified by the client

Over 25 successful sponsor audits and visits each year yield results that demonstrate our high standards of excellency. Regulatory audits confirm our compliance with all standards of GLP.

Mass Spectrometry: LC-MS/MS

Our Laboratory for Mass Spectrometry is equipped with:

• 16 Applied Biosystems LC-MS/MS systems, including API 3000, 4000 & 5000 systems
• SIL Shimadzu - PAL CTC Analytics - Waters Aquity UPLC & Spark Symbiosis injectors

We offer high throughput sample handling, including automated Solid Phase Extraction (Spark Symbiosis), to support time critical single rising dose studies.

Over the last fifteen years, we have implemented and validated more than 800 assay methods for LC-MS/MS & HPLC. Our group continues to develop new methods routinely. To obtain a complete list, please contact:

Martin Bakker, Ph.D.
Director of Business Development
EDS - Bioanalytical Laboratory
Westerbrink 3
9405 BJ Assen
The Netherlands
+31 592303419
BakkerMartin@praintl.com

Immunoassays

PRA utilizes ELISA, RIA and IRMA as analytical techniques for immunoassays, including automated immunoassays using the Immulite system and multiplex systems like the Luminex. Our laboratory team has expertise in method development and validation of assay methods for pharmacokinetic analysis of (recombinant) macromolecules and immunogenicity (antibody titers). We also offer Flow Cytometry analysis, a method to measure multiple physical and chemical characteristics of cells by optical means. This technique provides useful information about a broad range of cells and their functions.

Biomarkers

PRA's laboratory has approximately 300 validated methods available for an extended range of biomarkers for use in clinical studies. To obtain a complete list, please contact us.

Radiolabeled Analysis

PRA has a permanent license for analysis of radiolabeled compounds. Validated methods using one of the two available Liquid Scintillation Counters are available for ¹⁴C, ¹²⁵I, and ³H in several matrices, e.g.,:

• Whole blood
• Plasma
• Serum
• Urine
• Feces
• Breath samples

Biohazard Laboratory

The 30 m2 Biohazard Laboratory in Assen qualifies as a Bio-Safety Level II (ML-II) facility. PRA trains Laboratory personnel to use proper precautions and equipment when handling biohazardous substances to prevent endangering themselves, the community, and/or the environment. For example, our Biohazard Laboratory is qualified to handle samples from patients participating in trials dealing with such pathogens as Hepatitis B Virus, Human Immunodeficiency Virus (HIV) and Mycobacterium tuberculosis.

In-House Laboratory for Clinical Chemistry

PRA has a fully equipped clinical chemistry laboratory which supports analyses for our clinical units located in The Netherlands. Apart from its safety and handling advantages, the presence of an in-house laboratory for clinical chemistry is ideal for investigating blood coagulation parameters or undertaking intensive blood processing protocols. We also provide a wide range of pharmacodynamic efficacy assessments.

Our clinical laboratory supports stand-alone analyses for third parties, such as pharmaceutical and biotech companies and other CROs.

The clinical laboratory has over 20 years experience with an annual capacity of over several million samples. In combination with the Bioanalytical laboratory, PRA provides a complete package of laboratory services for clinical trials. Through collaboration with our logistic partners, we can provide clinical laboratory services for multi-center clinical trials.