The term “Bioanalysis” has become a buzz word in the pharma industry and has emerged as a critical tool in the process of drug discovery and development. Bioanalysis is the sub-discipline of analytical chemistry that covers the quantitative measurements of drugs and their metabolites, biological molecules as well as biotics like DNA, proteins, macromolecules in biological systems. The reliability of this analytical finding is of great importance in forensic and clinical toxicology. The application of bioanalysis in the pharmaceutical industry provides a quantitative measurement of active drugs or its metabolites for pharmacokinetics (PK), toxicokinetics (TK), and bioequivalence studies.
Strategies in the drug discovery and development are witnessing radical changes by the increasing contribution of pharmacokinetics and toxicokinetics. Drug discovery or design today follows the identification and characterization of new targets like enzymes or receptors, synthesis, and screening of new lead molecules for biological activities and characterization of leads.
The Dynamically Evolving Clinical Landscape
The clinical landscape for cancer is currently undergoing an exciting shift as the spectrum of available medicines has expanded beyond chemotherapy to a host of new molecularly targeted therapies. Oncology is a hot topic, as many bioanalytical techniques are used in the field of cancer research, diagnosis, and treatment. Current advancements in bioanalytical technologies have provided researchers with a greater insight into the cellular and molecular activity of living beings. Moreover, these techniques have facilitated disease identification, particularly in its early stages, thereby reducing morbidity and mortality rate, and improving the chances of remission. Broadly speaking, the bioanalytical method consists of two main components: sample preparation and detection of compounds. Sample preparation is a technique used to clean up a sample before analysis and to concentrate a sample to improve its detection, whereas sample detection is performed on biological fluids such as plasma, serum, or urine. Few methods like immunoassays, cell-based assays, Mass Spectroscopy, and usage of biomarkers are popularly used in bioanalytical techniques for the development of new drugs.
Immune monitoring of key changes in the immune system can provide important insights into the mechanisms that determine therapeutic response at the molecular and cellular levels. Immunoassays are bioanalytical methods which are used for quantization of the analyte depends on the reaction of the antigen with the antibody. Immunomonitoring techniques include traditional immunoassays that use specific antibodies to recognize the analytes of interest, immunoassays that target immune cells as well as nucleic acids. Highly specialized immunoassays have developed in the past two decades, and have been applied in human clinical trials. Flow cytometry is also a powerful tool to analyze multiple analytes via a variety of parameters on an individual cell basis.