Genentech

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 subdiscipline 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.

"Current advancements in bioanalytical technologies have provided researchers with a greater insight into the cellular and molecular activity of living beings"

Cell-based assays have been an important component in streamlining the drug development process, helping drugs be brought to the market quickly and efficiently, and their technological evolution is not slowing down. While cytotoxicity is the primary effect that drug developers use cell-based assays to quantify, biological activity, biochemical mechanisms. Due to their amenability to miniaturization and multiplexing, cell cultures are being used for high-throughput screening (HTS) to test many compounds under different conditions in parallel. Modern cell-based assays are combining the advantages of animal models and cell cultures to allow drug developers to identify problems with drug candidate leads at early stages. As a result, effective and safe drugs can be brought to those that need them, quicker.

Mass spectrometry (MS) accurately measures the mass-to-charge ratio of ions to identify and quantify different molecules within a single sample in an unbiased manner. Earlier MS was used for chemical analytics but not much for biologics. But now, in the past decade, the scenario has changed completely. Today most of the company are using the MS method to support PK and overall drugs development. Many MS-based methods have been developed to study specific targets of the immune response. MS-based imaging techniques have been used to visualize the spatial distribution of molecules to analyze biomarkers, metabolites, peptides, and proteins by their molecular masses. MS is instrument-based, which results in fewer hands-on, which makes it relatively cheaper in terms of maintenance, transfers, and developments in case of immunology research.

Biomarker the New Code

A biomarker is an informational biological substance that can be objectively measured and evaluated as an indicator of normal biological process, pathogenic processes and its progression or the pharmacologic responses to a therapeutic intervention. Robust and validated biomarkers are essential to improve diagnosis, monitor drug activity, and therapeutic response and guide the development of safer and targeted therapies for various chronic diseases. Recent advances in genomics, cytometry, and imaging in combination with bioinformatics and biostatistics have made it possible to accelerate the discovery and development of specific biomarkers for complex chronic diseases.

Real Challenges

However, with the implementation of these modern technologies, there are specific challenges that are faced by the pharma industry. One of the most widely prevailing problems is the shortage of skilled persons who can carry out the research dealing with the cutting edge technology. Another major issue is that many small and medium scale biopharma companies are mushrooming these days, none of whom are able to sustain for a longer time due to lack of capital and resources. CROs are not interested in investing in such companies as they tend to specialize in providing only a single solution. CROs are looking for a one-stop-shop where they can avail specialized services at convenience, while adding value for clients.

Toward a Brighter Future

The field of bioanalysis has matured significantly from early studies in drug metabolism using simple colorimetry and assays preparations. With the proliferation of sophisticated techniques, linking advanced separations with mass spectrometry as detection systems, automation and robotics, today’s bioanalysts are well equipped to deal with the modern challenges of analyzing xenobiotics at a much faster and accurate manner. Furthermore, bioanalysts are now involved with the discovery, measurement, and qualification of pharmacogenomic profiles and biomarkers and, subsequently, the development of diagnostic kits to individualize patient characterization and treatment. In today’s highly competitive global drug development arena, it is more important than ever that the modern bioanalytical laboratory is optimized for speed and success.