A biomarker is a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or biological responses to an exposure or intervention, including therapeutic interventions(1). With the development of innovative and personalized therapies, biomarker tracking is increasingly important to support the clinical development…

Biologics are drugs derived from complex molecules like antibodies. Over the last two decades they have re-emerged as…

Cell and Gene Therapies (CGTs) has an estimated market size value in 2022 of USD 8.22 billion and a revenue forecast in 2030 of USD 24.5 billion. This is a CAGR (compound annual growth rate) of 14.6% from 2022 to 2030. Needless to say, the…

Due to its ability to analyze multiple parameters across different cell types within a sample, flow cytometry provides rich and clinically valuable data sets from even small volumes of blood. However, flow cytometry is a challenging platform to master, and requires significant investment in equipment and technical training.

Flow Cytometry utilizes fluorescently labeled antibodies to detect specific biomarkers on the surface and within cells, and over the past few years, there has been a surge in reagents available for flow cytometry applications. Most of these have been developed using monoclonal antibodies raised in mice and conjugated to a range of fluorophores. However, there are still instances where suitable monoclonal antibody reagents/conjugates are not commercially available, and small-scale conjugations are not practical. In these instances, so-called indirect staining may be employed, where the binding of an unconjugated primary antibody is detected using a secondary anti-IgG antibody conjugate.

With the rapid progress of immune-modulating drug development, flow cytometry has found itself increasingly at the forefront of clinical trial assessment of safety and efficacy. This is not without challenges since flow cytometry analysis can be complicated and expensive, too often employs idiosyncratic experimental and analytical methods. So how can a platform without standardized methods and processes, be successfully applied to evaluate clinical endpoints?

As a Senior Director for Discovery in the pharma division at KCAS, I would like people to think of “Bioanalytical Discovery” as a stage in drug development; one where you are doing your final…

Tissue and Non-Liquid Matrices (such as cell lines, red blood cells, PBMCs, bone marrow aspirates, and suspension cells) are valuable matrices[] to test for biomarkers (PD) and drug levels (PK). Testing of tissues and…

Pharmacodynamics (PD) is defined as the study of the biochemical and physiological effects of drugs and the mechanisms of their actions. Where pharmacokinetics looks at how the organism processes the drug, pharmacodynamics studies…

Biomarkers can be defined and utilized for many purposes.  There are disease biomarkers as well as mechanistic or pharmacological biomarkers.  To reduce attrition and better understand a therapeutic, it is essential to be able to monitor the effectiveness of the therapeutic during drug development. Measurement of biomarker levels related to…

I have been studying Biological Markers (biomarkers) for over 25 years, but last 5 years they have exploded and become a key bioanalytical component to a drug’s success. Biomarkers are used to support drug…