Biomarker Analysis

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The image showcases a scientist at work in a laboratory, focused on pipetting a sample into a microtiter plate, which is commonly used for serial dilutions, assays, and various other biochemical tests. The plate rests on a bed of ice within a metal tray, suggesting that the samples require temperature control to maintain their integrity during processing. The scientist is dressed in a lab coat and gloves, following standard safety protocols, and wears a protective mask, indicating adherence to stringent health and safety guidelines. This setting highlights the meticulous and precise nature of laboratory work, with the scientist carefully administering each sample to ensure accurate results. The background is filled with laboratory supplies and equipment, reflecting a well-equipped and professional environment. Such an image on a website page dedicated to detailing bioanalytical services conveys the company's commitment to precision, expertise, and the use of state-of-the-art technology in their analytical processes. It underscores Alderley Analytical's capability to handle complex biological samples under controlled conditions, emphasizing their thoroughness and dedication to delivering high-quality bioanalytical data.

Where pharmacokinetic (PK) analysis describes exposure to the therapeutic- what the body does with the drug – pharmacodynamic (PD) analysis describe what the drug does to the body. Biomarker analysis plays a significant role in describing the PD effects of the drug.

In many cases biomarkers are an indication of the efficacy of the drug, and such pivotal biomarker assays are subject to full characterisation, as they are involved in decision making steps in the clinical development programme. Other biomarkers are often analysed as exploratory or investigative endpoints in a clinical setting.

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The current model for biomarker analysis is to determine the most suitable assay for its intended application – its context of use – and to apply a ‘fit for purpose’ approach to development and validation. Biomarker assays range from exploratory and discovery assays, that may need a simple qualitative assay, to pivotal safety biomarker assays, where a definitive / fully quantitative assay is required.

At Alderley Analytical we believe a key factor in a successful biomarker programme is an early detailed discussion of the aims and requirements of the biomarker assay with the sponsor, to ensure the design and execution of the most appropriate assay validation approach.

We offer biomarker assay development and validation employing single and multiplex assays, typically using MSD or ELISA platforms.

 

Explore the connection between Biomarker Analysis and Immunogenicity or how we integrate Biomarker Analysis within our GCP Regulatory Anaylsis.

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