From The Stage

Plaque Reduction Neutralization Tests (PRNT) and the Development of New Antiviral Drugs

Posted by BioAgilytix / / Uncategorized

While infectious disease has always been an important area of scientific and medical research, the recent pandemic has brought this discipline more clearly into the public eye. Understanding which infectious agents are currently of concern to global health and which will become a threat in the future is a complicated and serious undertaking within the scientific community. Infectious agents are a diverse group consisting of bacteria, viruses, parasites, and less common types such as prions. Each of these pathogens represents unique immunological or physiological mechanisms which must be considered when…

What Parameters Are Acquired from a PK Study?

Posted by BioAgilytix / / Uncategorized

The term “Pharmacokinetics” is derived from “pharmakon” and “kinetikos” in ancient Greek, meaning “drug” and “position in motion,” respectively. It is one of the principal assessments in the drug development process that describes what the body does to an administered drug substance and is essential data for defining safe and effective levels of drug to be administered.Currently, in drug development, there is a large variety of drug moieties with variable structures and pharmacological actions. Examples include small molecules, recombinant human proteins, fusion proteins, synthetic peptides, oligonucleotides, monoclonal antibodies, bi- and…

The Broad Array of Vaccine Options for COVID-19

Posted by BioAgilytix / / Viruses

As we pass the two-year anniversary of the start of the coronavirus pandemic, we are reminded of where we started and how far we have come. From day one, we have been able to witness scientific advancements on the world stage as the scientific community quickly came together to address this international health crisis. Through these incredible, coordinated efforts by scientists and companies across the globe, we now have a range of tools with which to combat COVID-19, including multiple vaccines which have been shown to reduce the severity and…

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

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,…

Cell and Gene Therapies Account for a Large Portion of the Therapeutics Market

Posted by BioAgilytix / / Gene Therapy, Industry Update

Cell and gene therapies have gone through a growth spurt in the last decade. According to data from the Alliance for Regenerative Medicine (ARM), during the first three quarters of 2020, regenerative medicine research and development broke records at nearly $16 billion in global financing. From the treatment of knee injuries to osteoarthritis, certain cancers and even muscular dystrophy, advances in gene and cell therapies have definitely caught the attention of medical professionals, and for good reason. Cell and Gene Therapies Account for a Large Portion of Therapeutic Market Share…