In the context of pharmaceutical drug development, bioanalysis refers to the quantitative evaluation of drugs, metabolites, and biomarkers in biological fluids such as blood, serum, plasma, saliva, urine, or tissues.
Bioanalysis is a key pillar supporting the drug discovery and development platform.
Drug Development Process
Developing a drug for its clinical application in treating a disease is complex and lengthy. It involves several distinct stages, starting with discovery and development (step 1), preclinical research (step 2), clinical research (step 3), Review by regulatory authorities such as the US FDA (step 4), and post-market safety monitoring (step 5). The drug discovery and development step involves target discovery, characterization, validation, and lead generation supported by basic laboratory research. Preclinical trials involve extensive in vitro and in vivo testing of the lead candidate to assess its safety and formulate dosing. Upon approval of preclinical results, the lead candidate moves to the clinical research. The clinical research step broadly comprises four key phases; however, the final phase focuses on monitoring safety and efficacy upon marketing the drug. After phase 3 of the clinical trial, regulator authorities review the drug application and might approve or reject the application based on the clinical trial results.
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Each of these steps, preclinical and clinical trials particularly, involves extensive bioanalytical testing of the drug to determine its pharmacokinetics (absorption, distribution, metabolism, and excretion of the drug), pharmacodynamics, toxicological effects, optimize dosing, and assess safety and efficacy.
Role of Bioanalytical Solutions
With evolving disease-causing vectors, new therapeutic challenges are created. In addition, there is a need to improve the outcomes of existing treatment regimens for various diseases and to find a cure for others that have been untreatable till now. This warrants the need to discover new drugs and develop therapies that are more effective and personalized. However, this also implies that the demand for bioanalytical solutions would rapidly expand to support the drug discovery and development pipeline. Bioanalysis is an integral aspect of the pharmacokinetic and pharmacodynamic characterization of the drug molecule. Contract research organizations (CROs) and other biotech companies leverage this scope and offer GLP-compliant bioanalytical solutions for different stages of the drug development process to pharmaceutical giants that are involved in the actual drug development. These organizations may develop the bioanalytical methods, validate them, and perform the sample analysis if required. They have the needed bioanalysis lab, the latest technology platforms, and the flexibility to adapt to any approach, expertise, and skill set.
These companies offer a wide range of bioanalytical lab services such as ADME screening assays for evaluation and optimization of ADME properties; LC-MS services supporting PK testing; immunoassay services including PK ELISA assay, MSD, ECL, NAb, and ADA assays to determine PK and immunogenicity; mass spectrometry and ligand-binding assays to biomarker discovery and profiling; inductively-coupled plasma mass spectrometry-based support for oncology therapeutics; among others to ensure successful regulatory filling of drug applications. They also offer services to support the analysis of data generated from sample measurements using robust software and AI tools.
These bioanalytical lab services seamlessly fit into the main drug development pipeline and accelerate the workflow. Thus, the pharmaceutical giants can focus on other crucial aspects of drug development instead of worrying about the nitty-gritty details of bioanalysis at each step.
