<a href="https://www.bioagilytix.com/blog/category/cmc-bioanalytical/">CMC Bioanalytical</a>
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…
<a href="https://www.bioagilytix.com/blog/category/bioagilytix-insight/">BioAgilytix Insight</a>
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.
<a href="https://www.bioagilytix.com/blog/category/cell-therapy/">Cell Therapy</a>
CLIA Requirements for Gene and Cell Therapy Programs
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…