Central Laboratory Services

ELISA

Unilabs has extensive experience in the development and validation of Enzyme-linked Immunosorbent Assays (ELISAs) for biomarker analysis of biological material such as whole blood, serum, cerebrospinal fluid (CSF) and other human and animal matrices. Our technical ELISA staff are fully trained and highly skilled bioanalysts. Our lab facilities are fully equipped with state-of the art equipment, which is  interfaced with our LIMS system to ensure high quality data. Currently, we analyse approximately 100,000 samples in our ELISA laboratories each year.

ROUTINE BIOCHEMISTRY 

Unilabs performs a wide range of routine biochemistry analyses in support of various national and International Healthcare providers. All methods are validated prior to implementation and Unilabs participates in external QC proficiency programs where these are available. The majority of our healthcare methods are fully accredited.  Most routine analyses are performed using automated analysers, which are subject to extensive equipment qualification and maintenance. Data handling and reporting are also automated via our LIMS system, which also provides electronic sample management facilities.

HEMATOLOGY 

In support of national and International healthcare providers as well as clinical research studies Unilabs expert hematology laboratory provides fully accredited hematological measurements. The classification of components of the blood is performed on automated hematology analysers performing complete blood count parameters and white blood cell differential counts. In addition, the laboratory offers manual differential analysis on blood smears.

URINALYSIS

Unilabs determine pathological changes in urine using point-of-care urine analysers followed by microscopic examination, counting cells, yeast, crystals and other substances on the urine sediment if required. 

COAGULATION

Unilabs has experience in development and validation of methods performed on fully automated random-access multi-parameter coagulation analysers. These are designed to perform coagulation, chromogenic and immunologic assays.

HPLC AND LC-MS/MS

In our Centers of Excellence in York and Copenhagen we have long track records in small and large molecule analysis in support of biomarker and biologic development. Please also consult our York Bioanalytical Solutions web page for further information on small molecule analysis. 

MOLECULAR GENETICS 

Unilabs has extensive experience in purification of nucleic acids from different sample materials and subsequent quantification and genotyping by qPCR. Our molecular services can support a variety of DNA/RNA analyses including detection of genetic variation (e.g. SNP genotyping, mutation detection and copy number variation (CNV) analysis), gene expression and pathogen detection/quantification. We are experienced and equipped with high technology automated platforms for high throughput analysis.  Our laboratory facilities for molecular genetic testing include separate areas for specimen preparation, amplification, product detection, and reagent preparation, and our standard operation procedures ensure a unidirectional workflow for amplification procedures. 

PK/PD

Support to both GCP and GLP studies requires a thorough investigation of the pharmacokinetic and pharmacodynamic behavior of the drug substance. This is a key aspect of a new drug’s profile which has to be extensively investigated and reported in regulatory submissions. 

BIOMARKERS

In support of national and International healthcare providers as well as clinical research studies Unilabs expert hematology laboratory provides fully accredited hematological measurements. The classification of components of the blood is performed on automated hematology analysers performing complete blood count parameters and white blood cell differential counts. In addition, the laboratory offers manual differential analysis on blood smears.

Examples of our experience in providing biomarker analysis services include – but are not limited to:

• Biomarker analytical support from toxicology  through to clinical studies and commercialisation
• Method development, qualification and validation according to current regulatory and industry guidelines
• Use of surrogate matrix in biomarker and analyte methodology
• Diabetes biomarkers panel to support clinical development
• 24 hr fast turnaround analysis to support studies
• Sub pg/mL LLOQ biomarkers in LC-MS/MS
• Clinical safety biomarkers
• First in human biomarker support to provide early proof of concept data
• Exploratory biomarker qualification and support
• Broad range of the latest technologies including LC-MS/MS, immunoassay, MSD, flow cytometry, PCR and automated biochemistry
• Customisaiton of every project – no matter the number of patients. This ensures you get exactly what is required for the project without unnecessary expenses

IMMUNOGENICITY/ADA

As large molecules, the new class of biologics have the potential to elicit immune responses. Reliable and specific laboratory tests for the presence of anti-drug antibody (ADA) after dosing with a new drug candidate are important for a valid assessment of a patient’s immune response. Our extensive experience in ADA method development and validation makes us your perfect partner for all elements in the investigation of antigenicity, including the development of screening and confirmatory assays, and if required, subsequent titer evaluation of any identified ADA responses. If follow-up is required for the investigation of neutralising antibody status, we may be able to offer cell-based assay technology through our partner laboratories.