Advanced Therapies (ATMP)
Validation of qPCR Assays for Gene Therapy
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…
Update on CAR T-Cell Therapies for the Treatment of Cancer
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…
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 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…
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…
The Benefits of Hiring the Right CRO
Short for Contract Research Organization, a CRO is a company that provides clinical research support to the pharmaceutical, biotech and medical industries on a contract…
CLIA, COLA & CAP: What’s the Difference?
BioAgilytix’s CLIA Laboratory Director, Natalie Smith, outlines the differences between CLIA, CAP & COLA regulations & accreditations, and what they mean for laboratory testing quality.
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…