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Early Development Services

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Bioanalytical & Clinical Laboratory Services

Excellent bioanalytical record
PRA's Bioanalytical Laboratory in Assen, the Netherlands, is a GLP compliant laboratory and has an excellent 24-year record in bioanalytical activities, with over 2,400 studies executed. The spacious laboratory with state-of-the-art equipment includes facilities for mass spectrometry, high performance liquid chromatography, biochemistry and immunochemistry and certified laboratories for radioisotope analysis and handling of biohazard samples. Over 100 highly educated & experienced employees use their best efforts to executed all studies according to sponsor requirements. The lab is located within close proximity to our Phase I clinics in Zuidlaren and Groningen.

Our specializations
Our laboratory specializes in development, implementation and validation of assay methods and bioanalysis samples from clinical and preclinical studies, conducted either in our own clinical research center or in other study centers. The laboratory, which has earned widespread regard for high scientific standards, offers the following services:

• Method development or implementation and validation
• Bioanalytical Protocol design and Protocol writing
• Analysis of clinical and preclinical study samples
• Bioanalytical reports prepared to standard templates or as specified by the sponsor
• Electronic data transfer

Our high standard is illustrated by over 30 sponsor audits performed each year. Regulatory audits confirm compliance with all standards of GLP.

Biomarkers
PRA's laboratory has approximately 300 validated methods available for an extended range of biomarkers for use in clinical studies:

• Metabolism (e.g. Insulin, C-peptide, glucagons)
• Disease markers (e.g. Albumine, b2-microglobulin)
• Thyroid function (thyroid stimulating hormone)
• Inflammation (cytokines)
• Signal transduction (cAMP)
• Androgen assessment (e.g. androstenedione, testosterone)
• Fertility and reproduction (e.g. estradiol, FSH, LH)
• Mineral/salt balance (e.g. ACTH, Aldosterone)
• Bone and mineral metabolism (telopeptide, PTH)
• Growth Factors (e.g. hGH, erythropoetin)

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, combined with SIL Shimadzu, PAL CTC Analytics and Waters UPLC 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 implemented and validated more than 800 assay methods for LC-MS/MS & HPLC, and new methods are developed routinely.

Chromatography
The Laboratory for Chromatography has 5 HPLC systems (UV FL and ECD detection). We have equipment for automated sample preparation, and we apply column switching techniques. More than 200 validated assays are available, including several methods for compounds frequently used in drug interaction studies.

Radiolabeled analysis
PRA has a permanent license for analysis of radiolabeled compounds. Validated methods are available for ¹⁴C, ¹²⁵I and ³H in several matrices (e.g. whole blood, plasma, serum, urine, feces and breath samples from Mass Balance studies) using one of the two available Liquid Scintillation Counters.

Another core activity is Metabolite Profiling using HPLC in combination with a fraction collection and LSC or HPLC online with radio flow detection. In combination with our chromatography knowledge, we regularly perform metabolite identification using Mass Spectrometry.

Biohazard Laboratory
The 30 m2 Biohazard Laboratory in Assen qualifies as a Bio-Safety Level II (ML-II) facility. With this qualification, laboratory workers can handle hazardous substances without endangering themselves, the community and/or the environment. For example, samples from patients participating in trials dealing with such pathogens as Hepatitis B Virus, Human Immunodeficiency Virus (HIV) and Mycobacterium tuberculosis can be handled in our Biohazard Laboratory.

Immunoassays
We exploit ELISA, RIA and IRMA as analytical techniques for immunoassays, including automated immunoassays using the Immulite system and multiplex systems like the Luminex.

Our laboratory has wide experience 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.

Laboratory for clinical chemistry in house
PRA International (EDS-NL) has a fully equipped clinical chemistry laboratory, which is supporting analyses for EDS-NL clinical units in Zuidlaren and Groningen.

The presence of a laboratory for clinical chemistry in house is, apart from its safety purpose, ideal for investigating blood coagulation parameters or undertaking intensive blood processing protocols, e.g. for CD-factor fixation, ex vivo LPS or PHA challenge assays. We can also provide a wide range of pharmacodynamic efficacy assessments.

In addition, our clinical laboratory can also support analyses for third parties, such as pharmaceutical & biotech companies and other CRO's.

The clinical laboratory has over 20 years experience and the annual capacity is several millions samples. PRA also operates a Bioanalytical Laboratory in the direct vicinity of Zuidlaren. The combination of both laboratories provides a complete package of laboratory services for clinical trials. Through our collaboration with our logistic partner ABL (Assen, The Netherlands), we can also provide clinical laboratory services for multi-centre clinical trials in which PRA International participates.

Page last updated: 16 July 2008