From The Stage

Overcoming the Challenges of Critical Reagent and Kit Lot-to-Lot Variability in Support of Clinical Trial Biomarker Studies

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Biomarkers

Critical reagents are essential components of ligand binding assays (LBA), and include many reagent categories including antibodies, engineered proteins, conjugated proteins, chemically synthesized molecules, complex biologics, and solid-supported reagents. Their unique characteristics are crucial to assay performance, and as such, they require thorough characterization and documentation. Additionally, generation and/or the purchase of critical reagents is a large investment, so setting up proper ways to manage them is extremely important to maintaining the integrity of your assays for years to come. The most important benefit of a critical reagent management system…

Quality is More Than Good Laboratory Practice (GLP): Perspectives From an Advanced Quality Laboratory

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Bioanalytical Lab Quality

Good Laboratory Practice (GLP). This term is far from new to the world of laboratory science. In fact, the initial development of GLP principles can be traced back to 1978, when the FDA released a set of guidelines intended to create a verifiable testing record in laboratory testing throughout the United States.Since then, GLP has become the industry‚Äôs touchstone for reliability and repeatability in the laboratory setting. Many point to GLP adherence as indicative of an advanced commitment to quality. Though related, the two are actually quite different.While an advanced…