Eurofins Central Laboratory

Global Clinical Safety and Specialized Testing

Full package of routine and non-routine laboratory testing, including:

• clinical chemistry
  
• hematology
  
• immunochemistry
  
• urinalysis
  
• coagulation testing
  
• flow cytometry
  
• biomarkers
  
• hormones
  
• cell markers
  
• cytokine profiling
  
• infectious disease serology
  
• DNA/RNA isolation and long term storage
  
• routine genomic testing

DiaSorin RIA method

Eurofins integrates routine and specialized genomic testing to support any clinical trial.

By using RNA and DNA analysis methodologies, we help our customers to understand why patients with identical conditions react in a different way to an equal drug treatment. Some patients can be designated as non-responders or may even experience severe adverse effects that can be attributed to genetic variation. Genetic information can also be of predictive value to determine whether clinical trials subjects are included or excluded based on protocol requirements.

Routine genomic testing services:

• PBMC isolation
  
• RNA/DNA extraction and long term storage
  
• HLA Typing
  
• Genotyping and SNP analysis
  
• Logistic services to support specialty genomics
  
• Specialty genomics performed at Eurofins Medigenomix:
  

Gene Expression Analysis
DNA Sequencing
Large scale DNA and RNA extraction
Large scale genotyping and SNP analysis

For some drugs under investigation, a variation in bioavailability has been observed. If these drugs also have a narrow therapeutic index, there is a great need for regularly measuring the serum or plasma drug concentrations to ensure drug effectiveness and subject safety. For instance, transplant recipients undergoing immunosuppressive therapy need to be monitored closely.

Eurofins Central Laboratory has extensive experience providing high quality, real-time data for these purposes, and has dedicated therapeutic drug monitoring (TDM) staff in its central laboratory operations in the United States, Europe and Sinapore. The combined expertise of the staff, as well as the physical proximity of the laboratories to clinical sites, allows for quality reporting of TDM results with incredible efficient turnaround.

Clinical Virology Services

Unsurpassed experience in clinical virology, Eurofins capabilities in clinical virology support the development of a wide variety of applications including vaccines, anti-viral agents, oncology, transplantation medicines, and various other immunomodulating therapeutics.

Eurofins provides the full complement of clinical virology laboratory services for anyone in the biopharmaceutical industry engaged in the development of anti-infective products. Our Virology service strongly complements existing capabilities that include global central laboratory microbiology and safety services, pre-clinical microbiology services, bioanalytics, genomics, and biomarker analysis.

Led by highly experienced experts in infectious diseases, Eurofins not only validates and implements state of the art technology that has been approved by Regulatory Authorities, but is also able to develop, validate, and implement de novo assays required to support specific clinical development needs. The spectrum of assays, which can be deployed to Eurofins sites globally, includes immunologically based tests for antigen and antibody, molecular platforms for the detection, quantification, and sequencing of viral nucleic acids, as well as classic virology approaches.

At Eurofins Central Laboratory, we emphasize our dedication to scientific and technical flexibility to meet any unique requirements that may be a critical aspect of your products clinical development.

Immuno-Assays:

• Anti-HAV, anti HAV IgM
  
• HBsAg, anti-HBc, HBeAg, HBc IgM, anti-HBe, anti-HBs
  
• Anti-HCV
  
• Anti-HEV
  
• Anti-HIV (1 &2)
  
• Anti Rubella IgG & IgM
  
• Anti-CMV IgG & IgM
  
• Anti-Parvovirus B19
  
• Anti-EBV
  
• Anti-VZV
  
• Anti-HSV1/2 IgG &IgM
  
• Anti-measles
  
• Anti-mumps
  

Molecular Biology

• HBV
  
• HCV
  
• HIV
  
• CMV
  
• HSV
  
• EBV
  
• Rotavirus
  
• BK Virus
  
• JCV
  
• HPV
  
• Adenovirus
  
• Influenza
  
• Parvovirus B19
  
• Global Platforms
  

Eurofins deploys the latest and industry standard technologies and platforms, including qReal Time PCR, Multiplex PCR, Roche Cobas Ampliprep/Amplicor/TaqMan, Advia Centaur, ELISA automated processing, Diasorin Liaison, Elispot, and various cell culture based techniques.

Clinical trial supporting services

• logistics support and courier management
  
• import and export licenses consultancy for Asia-Pacific
  
• investigator site support
  
• multilingual regional helpdesk on three continents
  
• sample management and storage
  
• project management
  
• data management

Biomarkers in clinical trials

At Eurofins Central Laboratory, our approach in the field of biomarkers is to build a true, progressive partnership with our customers by offering practical, technical and scientific support. Understanding customer requirements is essential for us to propose an appropriate scientific, technical and economic solution for the use of biomarkers in clinical trials.

Within our dedicated Biomarker Group a team of dedicated study directors is coordinating and leading studies for validation of biomarker assays, as well as the analysis of study samples. For each project a single contact person is responsible for the logistics providing the appropriate sampling, storage and shipment conditions. Our logistic expertise reduces the organizational efforts for the sponsor and leads to the best sample quality.

Biomarker Services

• Fit-for-purpose advanced validation and analysis of commercially available biomarker assays
  
• PK analysis of endogenous compounds (large molecules)
  
• Feasibility assessment and scientific consultancy

Drug-drug interaction studies

• Method development and transfer
  
• Dried Blood Spots method development and analysis of small and large molecules

Bio-equivalence studies

During clinical trials, it is sometimes imperative to monitor drug levels in subjects in real-time, which allows medical monitors and clinical investigators to adjust dosing in order to meet the subject needs and study requirements. This is particularly critical in later phase trials where non-healthy volunteers are involved and their treatment regimen is dependent on accurate, timely reporting of their drug levels.

Additionally, clinical bioanalysis methodologies require central laboratory sample management and logistics support. After determination of the analytical requirements of a study, study specific materials are assembled and supplied including investigator site manual, visit specific sample collection materials and IATA/ADR compliant shipping materials. All bioanalytical data are included in the global study results database allowing combined reporting of safety parameters, biomarkers and PK data.

Analytical Chemistry Services