From The Stage

Validation of qPCR Assays for Gene Therapy

Posted by BioAgilytix / / Uncategorized

Though the modern world has progressed a lot in terms of medical interventions and biomedicine, there still are a vast number of diseases and disorders that demand a rather unconventional approach to treatment. Gene therapy has evolved as a technique that aims to address some of these diseases by introducing into a patient a normal copy of one or more defective genes responsible for the patient’s disease. By repairing the damaged gene responsible for the disease, gene therapy aims to introduce a normal copy of the gene into cells containing…

BioAgilytix Adds Extensive Capabilities with the Acquisition of MicroConstants and 360biolabs®️

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BioAgilytix, a leading global contract research organization focused on supporting its pharmaceutical and biotech partners in all stages of drug development, recently acquired MicroConstants and 360biolabs®️. These acquisitions greatly expand the already impressive scope of BioAgilytix’s capabilities, scientific expertise and geographic footprint. As an independent bioanalytical testing industry leader, MicroConstants, now known as BioAgilytix San Diego, has been providing Good Laboratory Practice (GLP) compliant services for decades. Headquartered in San Diego, MicroConstants offers services such as method development and validation using Liquid Chromatography with tandem mass spectrometry (LC/MS/MS), High Performance…

Flow Cytometry in Bioanalysis: Application, Utility and Recent Advancements

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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

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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

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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

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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,…

Bioanalytical Testing Under GMP: Optimizing Cell-Based Potency Assays

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Cell-based bioassays are expected by health agencies as one of the release specification methods for potency assessments in the drug development process. We take a closer look at the inherent complexities that come with developing these assays under GMP, and ways they can be overcome.

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

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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

Posted by / / 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…