Georges Köhler and César Milstein: The birth of monoclonal antibodies They discovered the technique for monoclonal antibody production. They won the Nobel Prize in Physiology or Medicine in 1984. They directly led to the development of antibody-based therapies for a vast array of health conditions. Since their initial invention…

Ligand binding assays (LBAs) have been our core activity for decades. LBAs are commonly used to measure interactions between two proteins, a ligand and its receptor, a monoclonal antibody (mAb) and its target, or biologics and Anti-Drug Antibodies (ADA). Throughout the development of New…

With recent guidance released from the FDA, there are changes for PKs (Pharmacokinetics) and ADCs (Antibody Drug Conjugates) that must be clearly understood before making decisions for your drug product testing. ADCs combine the target specificity of monoclonal antibodies with the…

In recent years, immunology…

Neurodegenerative diseases affect millions worldwide. Fifty million people are living with Alzheimer’s disease or other dementias. Although Alzheimer’s disease is one of the most recognized, it is just one of many neurological disorders, such as Multiple Sclerosis, Parkinson’s, or Huntington’s disease. These conditions lead to a…

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…

Immunotherapy research is a rapidly expanding field with a pipeline of monoclonal antibodies in development to treat a range of cancers and autoimmune diseases. The mechanism of action (MOA) used by an antibody to mediate a therapeutic response must be fully defined to enable a candidate antibody to advance down the preclinical development pipeline. It is also required for all antibodies used in clinical research and regulatory IND filings in order to optimize dosing and assess the risk of detrimental side effects.

For most applications flow cytometry is used to identify cell populations and define bivariant terms of positive and negative sub-populations according to specific biomarkers, through the binding of fluorescently tagged monoclonal antibodies (mAbs). Typically, the cutoff between these populations is set relative to a control unstained population. Since the fluorescent intensity of a signal is proportional to the amount of monoclonal antibody bound to that cell target, this signal is directly related to the expression level of that target. However, for flow cytometry endpoints to be considered truly quantitative and fulfill the rigor of clinical utility, several obstacles needed to be overcome. In this blog, we explore the rationale behind quantitative flow cytometry, and the tools that are now being implemented to help achieve standardization.

Introduction of CAR-T Therapy T lymphocytes are engineered with synthetic receptors known as chimeric antigen receptors (CAR) in CAR-T Cell therapy. The CAR-T cell is an effector T cell that recognizes and eliminates specific cancer cells, independent of major histocompatibility complex molecules. (Zhai et al. 2018). Chimeric antigen receptors (CARs) cells have recombinant receptor constructs expressed in T cells to target cells expressing specific antigens.