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 AssaysThe 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, nevertheless fail to discriminate whether these antibodies are binding or neutralizing in nature. To detect NAbs,…

New Opportunities for Women in Science and Technology

Dominic Marasco
Posted by Dominic Marasco / / Uncategorized

In the last decade, women have made significant strides in their professional lives and scholarly pursuits. Even the political world has seen a boom in women running for public office. With all of these glass ceilings being shattered and hierarchical norms being reimagined, there is one industry that could use a boost. The Science, Technology, Engineering, and Mathematics (STEM) sector is seeing an increase in the number of women entering these industries, but there is always room for more.According to The American Association of University Women (AAUW), women only make…

Closing Diagnostic Gaps by Anti-α-Gal IgE Immune Profiling

Dr. Arno Kromminga
Posted by Dr. Arno Kromminga / / Uncategorized

I recently had the opportunity to work with a multicentric group of experts in immune profiling and immunogenic responses on the creation of a scientific peer-reviewed paper titled, “Meat allergy associated with galactosyl-α-(1,3)-galactose (α-Gal)-Closing diagnostic gaps by anti-α-Gal IgE immune profiling”. The paper, originally published in the European Journal of Allergy and Clinical Immunology in June of 2017, examines different α-Gal-containing analytes in singleplex and multiplex assays to resolve individual sensitization patterns with IgE against α-Gal. Glycoproteins and glycolipids of some mammalian species contain the disaccharide galactosyl-α-(1,3)-galactose (α-Gal), but it…

Biomarker Development: Clearing the Way for Faster Biomarker Innovation

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Biomarkers, Uncategorized

This spring, BioAgilytix attended The Biomarker Conference in San Diego along with other biomarker experts to discuss best practices for an industry that is still maturing in areas such as discovery, development, clinical application, and regulatory approval. A range of topics were covered, from identifying accurate biomarkers to developing standard protocols. The event ended with an exciting takeaway: while there are still many complexities involved in bringing new biomarkers to the clinic, substantial progress is already being made to create clearer paths for overcoming biomarker development challenges. Presenters at the…