Cell-based Assay
CMC Analytical Control Strategies for Drug Development
CMC (chemistry, manufacturing, and controls) is a term used when drug developers define their investigative drug substance, establish manufacturing methods for...
ADCC and CDC Assay: Validation and Optimization
Antibody dependent cellular cytotoxicity (ADCC) is a mechanism in host immune defense where antibodies bind to an antigen on the surface of a cell, targeting…
The Use of Cell-Based Assays for Translational Medicine Studies
Cell-based assays are an important tool in drug development. One of the biggest challenges when developing a drug is mimicking the appropriate physiological setting to predict…
Cell-Based NAb Assays: What We Need to Know
Cell-Based NAb Assays So, how do we deal with NAbs when it comes to the industrial production of biotherapeutic agents? The bioanalytical community adopts a…
Cell and Gene Therapies Account for a Large Portion of the Therapeutics Market
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…
CMC Requirements for Cell and Gene Therapy for IND Applications
The U.S. Food and Drug Administration (FDA) has issued Chemistry, Manufacturing, and Control (CMC) recommendations for Investigational New Drug (IND) applications for human investigational gene…
A Beginner’s Guide to Luciferase Assays
Luciferase is an enzyme used by a variety of organisms for bioluminescence. One of the most common examples of bioluminescence exists in the biology of…
Impact of Pre-Existing Immunogenicity Against AAV on Gene Therapy Trials
The concept of using pre-existing immunogenicity as an exclusion criteria for gene therapy clinical trials is changing. BioAgilytix’s Chief Scientific Officer, Dr. Jim McNally, explores…
Answering Your Questions on Developing a Relative Potency Assay for an Anti-Influenza mAb
Dr. Jeff Patrick answers questions on how BioAgilytix translated a diagnostic virus neutralization method to a quantitative relative potency assay for an anti-viral antibody.
Webinar Sneak Peek: Accelerating Testing of Therapeutics to Neutralize Viral Infections
On May 7, we'll be hosting webinar highlighting the importance of streamlining the time & cost of bioanalytical testing to support therapeutic development for viral…