Drug Development Solutions

Biomarkers (LC-MS & ligand binding)

Biomarkers are increasingly important in the development of pharmaceuticals and have a wide range of potential clinical utilities. In particular, an effective biomarker/s can assist in early phase decision making, as serve as an indicator/s of patient safety and drug efficacy. We have a wealth of experience in detection and quantitation of biomarkers in a wide variety of matrices.

Tailored services to match your clinical package

We have a proven track record of supporting studies in a wide range of therapeutic areas such as metabolic disorders (including diabetes and cardiovascular disease), inflammatory disorders (including rheumatoid arthritis), respiratory diseases (including chronic obstructive pulmonary disease) and anti-infectives. We can tailor your qualifications and validations to match the needs of your clinical program.

Biomarkers are re-shaping drug development

Our biomarker services can be adapted to your specific requirements:

• Assay development - Feasibility assessment, establishment and development with a wide variety of analytical methodologies, species and matrices.

• Validation - Leading expertise in helping clients develop the most appropriate strategies for validation based on the purpose of the biomarker. We validate both in-house and commercial assays to GCP or GLP standards in line with current regulations.

• Quantification - As a measure of drug safety or efficacy, or to prove a new drug’s mechanism of action. We have the capability for small and large molecules, molecular diagnostics and cell based assays.

• Capacity - As a pioneer in new analytical approaches and technology, we have invested in a broad range of analytical platforms and have one of the largest bioanalytical facilities with more than 200 scientists dedicated to drug development. This allows us to deliver a broad range biomarker solutions including the most large and complex clinical programmes.

Science for a safer world

lgcgroup.com/ddsRegistered OfficeLGC, Queens Road, Teddington,Middlesex, TW11 0LY

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For further information on how LGC can assist with biomarkers, please contact us:

lgcgroup.com/enquiries

+44(0)1638 720500

LGC’s Meso Scale Discovery Instruments

@lgc_dds @lgcgroup

@LGCDrugDevelopmentSolutions

Analytical methods and validated instrumentation

• ELISA based technologies using a range of detection techniques - colorimetric, fluorescence, chemiluminescence and time resolved fluorescence (3 x PerkinElmer EnVision plate readers)

• Randox Daytona and Immulite™ 1000 analyser systems for clinical biomarkers

• Gyrolab® xP for rapid, high sensitivity protein quantification using low sample volumes

• MSD® (Meso Scale Discovery, x2) - multi-array technology™ enabling the detection of biomarkers in single and multiplex formats

• Singulex Erenna® (x2) - verification and validation of low abundance (sub-pg/mL) biomarkers. Micro-particle based technology offers 10x better sensitivity

• Luminex MAGPIX® (x2) - multiplex technology for qualitative and quantitative analysis of proteins and nucleic acids

• Beckman Coulter CytoFlex (x2) - 3-laser, 13 colour flow cytometer for multi-parameter of cell surface antigens

• LC-MS (>20 instruments) - developing small molecule biomarker applications for when selectivity is an issue

• LC-MS large molecule bioanalysis quantification in biological matrices with the specificity of mass-based detection. Ability to couple with bead-based immunopulldown offers 100x greater sensitivity