CMC Requirements for Cell and Gene Therapy for IND Applications

DNA splicing genetic engineering

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 therapies. The focus of the guidance is on SISPQ (safety, identity, strength, purity and quality), critical quality attributes (CQAs) and risk assessment. These apply to new cell/gene therapy products that […]

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 studies devoted to pediatric cancer research, drugs, and therapies. Originally enacted in August 2017, as a part of the Food and Drug Administration (FDA) Reauthorization Act (FDARA), the RACE Act […]

The Benefits of Outsourcing R&D Processes to CROs

outsourcing rd processes to cro

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 pharmacokinetics. We perform assay development and validation as well as sample analysis, lot release testing and ongoing data surveillance after drug products are introduced to market. Committed to helping reduce […]