From The Stage

Not the Same, But Not Too Different: Demonstrating ‘Biosimilarity’ for Biosimilars with Comparative PK and Immunogenicity Assays

Todd Lester
Posted by Todd Lester / / BioAgilytix Insight, Biosimilars

As per the Food and Drug Administration (FDA) guidance Quality Considerations in Demonstrating Biosimilarity to a Reference Product, a biosimilar is defined as “a biological product that is highly similar to a reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.” Clinical pharmacology studies are a critical part of demonstrating this ‘biosimilarity’, and provide the data for the biosimilarity in drug…

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’s 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…

Taking the Stage on Bioanalytical Topics – Looking Back & Looking Ahead

Jim Datin
Posted by Jim Datin / / BioAgilytix Insight, Biomarkers, CRO Selection

Welcome to BioAgilytix’s new blog, which gives you the chance to tap the expertise and insights of our talented team on a regular basis. This forum gives us a new way to share firsthand scientific perspectives on everything from overarching bioanalytical industry trends to specific assay challenges, platform uses, case studies, and more.Like our Virtual Podium series – in which we engage industry thought leaders to share their expertise, experiences, and advice via timely, on-demand video segments – we hope that this blog will also become a valuable resource for…