From The Stage

Flow Cytometry in Bioanalysis: Application, Utility and Recent Advancements

Posted by BioAgilytix / / Uncategorized

Flow Cytometry in Drug DevelopmentFlow cytometry is a technique that is used to analyze multiple characteristics of single cells. These characteristics include cell size, cytoplasmic complexity of the cell, as well as expression of cell surface and intracellular proteins. This unique technology utilizes fluidics, optics, and electronic components to interrogate each cell by lasers as it flows through the sample stream. The dispersed light and emissions from excited fluorophores are collected and directed toward photodetectors that isolate specific wavelengths and convert them to digitized signals in the form of numerical…

Update on CAR T-Cell Therapies for the Treatment of Cancer

Posted by BioAgilytix / / Uncategorized

Chimeric Antigen Receptor (CAR) therapies are a type of cell therapy that consists of modifying immune cells to attack various forms of cancerous cells. While this is a relatively new therapeutic class, there are already a number of versions that are being developed or already approved for treatment.  Let’s start with the source of the cells being modified. In general, there are two categories of CAR immune cells: Autologous and Allogeneic. Autologous CAR therapies are derived from the patient’s own cells while allogeneic CAR therapies are typically taken from healthy donors…

Challenges for Measuring Immunogenicity of AAV-based Gene Therapies

Posted by BioAgilytix / / Uncategorized

Gene therapy is a powerful form of treatment that involves introducing genetic material into cells to replace defective genes resulting in the production of an essential protein. If a defective gene causes a required protein to be faulty or absent, gene therapy may be able to restore the protein’s function by introducing a “healthy” copy of the gene.Since gene therapy products work by introducing genetic material into the cell, scientists need a way to deliver DNA, RNA, or nuclease to the target tissue and cells. The delivery systems that carry…

Cell-Based NAb Assays: What We Need to Know

Posted by BioAgilytix / / Uncategorized

Cell-Based NAb AssaysSo, how do we deal with NAbs when it comes to the industrial production of biotherapeutic agents?The bioanalytical community adopts a tiered approach to tackle the problem of NAbs. Firstly, any study samples in question are first screened and confirmed for the presence of binding antibodies via an established immunoassay. If the sample tests positive for binding antibodies, it is then examined for any drug-specific neutralizing ability in a NAb assay. Standard immunoassays such as enzyme-linked immunosorbent assays (ELISA), electrochemiluminescent (ECLIA), and other assays can detect anti-drug antibodies,…