Challenges for Measuring Immunogenicity of AAV-based Gene Therapies
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…
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…
BioAgilytix Team Q&A: Meet Chris Carlin
Tell us a little about your background and how you came to join BioAgilytix. My first wet lab experience was gained during my…
BioAgilytix Team Q&A: Meet Reema Davis
Tell us a little about your background and how you came to join BioAgilytix. I did my doctoral and postdoctoral training in Cell…
BioAgilytix Team Q&A: Meet Nikhil Soni
Tell us a little about your background and how you came to join BioAgilytix. Some of my friends at my previous job joined BAL and…
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…
FDA RACE for Children Act: What You Should Know
Short for Research to Accelerate Cures and Equity, the RACE Act went into effect on August 18, 2020, and significantly increased the number of required…
The Benefits of Outsourcing R&D Processes to CROs
As a leading contract research organization (CRO), BioAgilytix helps companies around the world with research and development, leveraging expertise in cell-based assays, immunogenicity, biomarkers and…
Noninvasive Liquid Biopsy Assays Integrating Tumor and Immune Biomarkers Prove to Be Promising Tools in Immuno-Oncology
Tumor tissue biopsies have been the traditional method of identifying and analyzing cancer cells. But in addition to being invasive and risky, they have many…