Bioanalytical services - Method development and validation

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Bioanalysis is an indispensable part of drug discovery and development. It relates to the analysis of analytes (drugs, metabolites, biomarkers) in biological samples. Bioanalysis involves 3 steps:
• Sample collection
Either from clinical or preclinical studies.
• Sample preparation
A robust sample preparation method is essential in order to obtain dependable results. Sample clean-up is typically time consuming and labor intensive.
• Sample analysis and detection
Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is the preferred method for sample analysis in the context of clinical studies and drug development. LC-MS/MS has proven to be highly selective and highly sensitive.

Bioanalytical method development

A fully validated bioanalytical method is essential to generate dependable results. At BioNotus, methods and techniques for bioanalytical development and validation are subject to continuous innovations. Each bioanalytical method in the BioNotus assay portfolio is the result of custom method development according to the highest standards. Specific method validation criteria are in line with EMA / FDA regulations.
To support routine sample analysis, a tailored bioanalytical method is developed, validated as follows:
• Reference standard preparation
• Bioanalytical method development and establishment of assay procedure
• Application of validated bioanalytical method to routine drug analysis and acceptance criteria for the analytical run and/or batch
• Iterations of the above steps to improve assay performance

Bioanalytical method validation

During the course of a typical drug development program, a bioanalytical method will undergo many modifications. Different levels of validation are required to demonstrate continuity of the validity of an assay’s performance. Three different levels of bioanalytical method validation are defined:
• Full validation
When developing a new bioanalytical method for a new drug entity, full validation is required.
• Partial validation
A partial validation is a modification of an existing validated method that doesn’t require full revalidation. Partial validation of a bioanalytical method can vary from one assay accuracy and precision determination to a nearly full validation.
• Cross validation
A cross validation is necessary when 2 or more bioanalytical methods are combined to generate data within the same study. Cross validation is actually a comparison of two separate bioanalytical methods.

Biomarker analysis services

The bioanalytical laboratory at BioNotus can develop and validate methods to analyse biomarkers in preclinical and clinical samples such as plasma, serum, urine and saliva.
Often, biomarkers are primary or secondary endpoints in clinical trials, therefore performing biomarker analysis during drug development is critical to the success of clinical trials. Biomarker analysis can provide information on the different physiological pathways involved in disease progression and hence can be used to measure the safety and efficacy of the drug for a specific disease indication.

Biomarker testing

Biomarker testing is a group of tests that looks for these molecular signs of health so that doctors can plan the best care. Biomarker testing is a cornerstone of personalized medicine. Biomarker testing may also be called "molecular testing" or "genetic testing." Biomarker tests can be divided into three groups: chromosome, gene, and biochemical.

BioNotus is a contract research organization (CRO) specialised in the bioanalysis of drugs (medicines) in a diversity of complex (biological) matrices:

+ Blood, serum and plasma
+ Tissue and tissue homogenates
+ Cell lysates
+ Cell culture media
+ Dried blood spots

+ Urine
+ Saliva
+ Breast milk
+ Waste water from pharmaceutical production


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