Bioanalytical Laboratories

Lenexa, Kansas, USA

The Lenexa, KS, USA, laboratory opened in October 2010. This new laboratory is equipped with the most state-of-the-art equipment available for Bioanalysis. It is located in close proximity to PRA's Phase I Clinic also in Lenexa, KS. Although new in Lenexa, this laboratory is actively supported by 25 years of experience from PRA's European Laboratory. The facility's analytical capabilities include:

Laboratory for mass spectrometry
Ultra performance liquid chromatography
Future expansion into Ligand Binding Assays is envisioned

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

For more detailed information about our experience and capabilities contact:

Roger Greathead, Ph.D.
Director Business Development
GreatheadRoger@PRAintl.com

North American Bioanalytical Laboratory
11070 Strang Line Road
Lenexa, KS 66215 USA

Assen, The Netherlands

The Bioanalytical Laboratory in Assen, The Netherlands has more than 110 highly educated and experienced employees. This GLP-compliant laboratory that began operating in the mid 1980's is located in close proximity to PRA's Phase I Clinics in Zuidlaren and Groningen. The facility's analytical capabilities include:

Laboratory for mass spectrometry
Ultra performance liquid chromatography
Ligand Binding Assay laboratory (PK, Immunogenicity, Biomarkers)
Biochemistry (e.g. Stimulation assays, Enzymatic activity)
Flow Cytometry unit
Laboratory for radioisotope analysis
Biohazard laboratory

For more detailed information about our experience and capabilities contact:

Peter Ketelaar, MSc
Vice President Bioanalytical Laboratories
KetelaarPeter@PRAintl.com

European Bioanalytical Laboratory
Westerbrink 3
9405 BJ Assen
The Netherlands

Market Trends

With Chad Briscoe (Senior Director, Bioanalysis – North America)

Our Specializations

PRA's laboratories specialize in:

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

Over 20 successful sponsor audits and visits each year yield results that demonstrate our high standards of excellence. Regulatory audits confirm our compliance with all standards of GLP. Globally harmonized SOP’s ensure equally high standards of excellence in both laboratories.

Mass Spectrometry: LC-MS/MS

Our two laboratories for Mass Spectrometry are equipped with:

21 ABSciex MS/MS systems, including API 3000, 4000, 5000 & 5500
16 Shimadzu SIL- CTC Analytics HTC PAL HPLC systems
2 Shimadzu Nexera UHPLC systems
6 Waters Acquity UPLC systems

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

Over the last 25 years, we have implemented and validated more than 750 assay methods for LC-MS/MS & HPLC. Our group continues to develop new methods routinely. To obtain a complete list, please see List of LC-MS HPLC Assays.

Ligand Binding Assays and Immunogenicity

The Ligand Binding Assay Laboratory operates various platforms for the analysis of large molecules:

ELISA and RIA based immunoassays
Meso Scale Discovery, Sector Imager 6000 (ECL; single and multiplexing)
Luminex; Bio-Plex 200 (single and multiplexing)
Fluoroscan Ascent (real-time fluorometer)
Cell stimulation assays (microbiology units)
Surface Plasmon Resonance (Biacore 3000)
Western Blotting
Fully automated analyzers (see Central Laboratory)

Our laboratory team has expertise in method development and validation of assay methods in various specialist areas:

PK analysis of large molecules, including peptide, protein, RNA and antibody drugs
Immunogenicity and anti-drug antibody (ADA) assays; screening, cutpoint and titer assessment, confirmation assays, isotyping, antigen typing, Neutralizing Antibody assays
Biochemistry assays: cell stimulation assays (whole blood, PBMC's) and (inhibition of) enzymatic assays
Biomarker and safety assays: approximately 300 validated methods available for an extended range of biomarkers for use in clinical studies. To obtain a complete list, please see: List of Biomarker Assays.

Flow Cytometry

PRA's FACS Unit is operated by a dedicated team of analysts and offers Flow Cytometry analysis parallel to clinical studies run in our own clinical units or at sponsor or third party sites. Flow Cytometry provides useful information about a broad range of cells and their functions. Our experience comprises:

Quantitative assessment of white blood cell subsets
Assessment of cell surface antigens (phenotyping)
Cell receptor occupancy (surrogate PK assays)
Assessment of the activation status of various cells
Assessment of cell function; e.g. intracellular cytokine production and apoptosis

Radiolabeled Analysis

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

Whole blood, Plasma, Serum, Urine, Feces, Breath samples and
various tissues (homogenates) and materials (tissue wipes, clothing)

Biohazard Laboratory

The 30 m2 Biohazard Laboratory in Assen qualifies as a Bio-Safety Level II (ML-II) facility. PRA laboratory personnel are trained 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&C Virus, Human Immunodeficiency Virus (HIV) and Mycobacterium tuberculosis.

Business Development

Please contact one of our colleagues from the Business Development Department for more detailed information about our experience and capabilities:

Peter Ketelaar, MSc
Vice President Bioanalytical Laboratories
KetelaarPeter@praintl.com

EDS - Bioanalytical Laboratory
Westerbrink 3
9405 BJ Assen
The Netherlands

Roger Greathead, Ph.D.
Director Business Development
greatheadroger@praintl.com

EDS – Bioanalytical Laboratory
11070 Strang Line Road
Lenexa, KS 66215
USA