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…

CLIA, COLA & CAP: What’s the Difference?

Posted by / / BioAgilytix Insight, Regulatory Considerations

BioAgilytix’s CLIA Laboratory Director, Natalie Smith, outlines the differences between CLIA, CAP & COLA regulations & accreditations, and what they mean for laboratory testing quality.

CLIA Requirements for Gene and Cell Therapy Programs

Posted by / / Cell Therapy, Gene Therapy, Regulatory Considerations

It's a common misconception that all aspects of cell & gene therapy research and development are excluded from CLIA oversight. We take a closer look at testing and when CLIA requirements apply.