The Critical Role of Bioanalytical Services in Drug Development

The drug discovery and development process is a complex initiative. The primary objective of drug discovery and development is to identify compounds and evaluate their properties to assess the feasibility of transforming the candidate compound into a safe and effective drug. Today, the entire drug development space is undergoing a radical transformation. For example, the contribution of LC-MS/MS method validation and development is increasing in drug discovery and development. Besides, approaches such as pharmacokinetic and toxicokinetic evaluations are now an integral component of drug toxicity testing. 

Considering the importance of drug discovery and development, bioanalytical solutions are emerging as a crucial indicator of the success of drug development projects. In the last few decades, newer bioanalytical assays have been developed and validated to support drug discovery and development initiatives. The data from such bioanalytical studies generated during the discovery and clinical stages of drug development often prove valuable in clinical decision-making. Here, bioanalytical laboratory services play a crucial role in accelerating drug development timelines. The current article focuses on the critical role of bioanalytical laboratories in drug development. 

Role of bioanalytical labs

Bioanalysis can be defined as the quantitative assessment of drug products and their metabolites in biological fluids. Sample preparation and detection of the compound of interest are the two main components of a bioanalytical method. 

Sample preparation is a step that cleans samples before analysis. Sample preparation also helps in concentrating a sample and improving its detection capacity. Most bioanalysis requires a sample preparation step such as protein precipitation, solid-phase extraction, and liquid-liquid extraction to remove the protein components from the sample. 

Bioanalytic companies have several detectors, such as a mass spectrometer, for detecting the compound of interest. Several detection techniques, including HPLC-MS/MS analysis and multiplex ligand binding assays, are widely used to assess biomolecules in clinical samples. 

However, before employing a bioanalytical assay for routine purposes, bioanalytical laboratories must validate the method in intended study samples. Method validation compliance with GLP regulations is crucial to support drug development studies. Bioanalytical services are experienced in validating biomedical methods. They ensure that all bioanalytical methods are evaluated based on FDA parameters, including selectivity, stability, accuracy, the limit of quantification, calibration models, recovery, and reproducibility. Robust bioanalysis services ensure that all laboratory investigations are performed using reliable bioanalytical applications and thoroughly documented. Acceptance of bioanalytical data directly correlates with a validated bioanalytical method. 

The initial stages of drug discovery usually do not require fully validated bioanalytical methods. Bioanalytical studies used in pre-clinical research and phase 1 and phase 2 clinical studies are focused mostly on the linearity, specificity, and precision parameters of bioanalytical methods. The remaining parameters of bioanalytical validation are then performed in phase 2 and phase 3 clinical studies.

Such an approach becomes more feasible as drugs advancing in the later stages of clinical trials have more chances of reaching the intended patient population. Hence, it makes sense to employ robust and more rigorous validation approaches in the final stages of drug development. Notably, bioanalytical labs are exposed to a wide range of clients and drug development projects. Hence, they are regularly audited and updated according to regulatory requirements.

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