From The Stage

CMC Requirements for Cell and Gene Therapy for IND Applications

Posted by BioAgilytix / / Regulatory Considerations

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 have been developed in recent years. The FDA’s requirements, updated in January 2020, cover critical factors such as: Specification/characterization of manufacturing materials Filing and submission practices (i.e. eCTD or not) Manufacturing processes/procedures Product testing considerations…

FDA RACE for Children Act: What You Should Know

Posted by BioAgilytix / / Industry Update

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 Originally enacted in August 2017, as a part of the Food and Drug Administration (FDA) Reauthorization Act (FDARA), the RACE Act is an amendment to the Federal Food, Drug, and Cosmetic Act (FFDCA) which was created to extend user-fee programs for drugs, medical devices, and biosimilars, as well as other biological products. Key Factors of the…

The Benefits of Outsourcing R&D Processes to CROs

Posted by BioAgilytix / / CRO Selection

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 drug development timelines and costs, we are not alone in this growing industry. In fact, our work represents the larger-scale trend of pharma companies outsourcing R&D to CROs specializing in state-of-the-art technologies and expertise. The…