Biomarker Analysis

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Through our global network of testing experts and analytical equipment including chromatography (HPLC, GC, GC/MS) and atomic absorption spectroscopy (AAS, GFA, FIAS), Our goal is to provide test services as efficiently as possible to maximize our customers' profits. For more information about our services, contact one of our experts today.

Note: this service is for Research Use Only and Not intended for clinical use.

Biomarkers are playing an increasingly important role in the pharmaceutical process. For pharmaceutical companies, the cost of developing new drugs has risen sharply, while the number of drugs approved by regulators has decreased. Thus biomarkers make drug development a more efficient and cost-effective process. Biomarker is a kind of index that can objectively measure and evaluate normal biological process, pathological process or drug intervention reaction, and it is also an important early warning index when organism is damaged, involving changes in the molecular structure and function of cells, as well as changes in biochemical and metabolic processes. As part of precise medicine, more and more biomarkers are being developed with therapeutic compounds to aid diagnosis and provide the right drugs to the right patients. Therefore, the biomarkers developed by the pharmaceutical industry must be evaluated and validated through a rigorous process.

With years of testing experience and a wide range of analysis platforms, Alfa Chemistry's drug development scientists can provide customized biomarker solutions for you. Whether it's development or validation of biomarkers in preclinical and clinical samples, regardless of your field of research metabolism, immunity, antineoplastic, respiratory, etc., our analysis team is willing to use our experience to support your biomarker analysis needs. If you have any questions about biomarker analysis, please feel free to contact us.

Table 1 Biomarker types and definitions¹.

Biomarker type	Definition
Target engagement	Fraction of target binding sites occupied by a drug.
Pharmacodynamics	Drug effects on the human body to assess whether the downstream pathway or biological process regulated by a drug target is perturbed upon drug administration. These could be proximal or distal to the target. An ideal PD marker should show dose or exposure responsiveness and some correlation with efficacy. PD biomarkers are critical to establishing PK-PD models to help define safe and effective doses.
Disease activity	Effects of a drug on a particular disease, which occur late in the pathophysiologic cascade and are linked to clinical benefit. Also referred as POC biomarkers. These are also useful for PK-PD modeling.
Surrogate endpoint	Substitution for a clinical endpoint and prediction of clinical benefit with certainty. In some cases, such as with HIV viral load and hemoglobin A_1c, these may be used as phase III endpoints to support marketing approval.

Alfa Chemistry's capabilities include but not limited to:

Biomarkers identification and validation studies.
Comprehensive evaluation of the use of biomarkers.
Biomarker analysis to support preclinical and clinical development.
Assessment of drug safety and efficacy.

Alfa Chemistry's technology platforms include but not limited to:

Enzyme Linked Immunosorbent Assay (ELISA)
Two-dimensional Difference Gel Electrophoresis (2-D DIGE)
Hydrophobic Interaction Chromatography (HIC)
Capillary Electrophoresis (CE)
Fourier Transform Ion Cyclotron Resonance-Mass Spectrometry (FTICR-MS)
MALDI-TOF-MS
ESI-QTOF-MS

Alfa Chemistry's advantages:

Short Detection Cycle
Competitive Price
Experienced Team of Experts

First-class Equipment
Reliable Results
Familiarity with Various Standards

Reference

Xuemei Zhao. (2015) 'Biomarkers in Pharmaceutical Research.' Clinical Chemistry. 61(11): 1343–1353.

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