From The Stage

Supporting CAR-T Therapies, Part 1: Innovation to Overcome Bioanalytical Challenges

Dr. Corinna Fiorotti
Posted by Dr. Corinna Fiorotti / / BioAgilytix Insight, Cell Therapy

Most bioanalytical methods for canonical small or large molecule drugs utilize ligand binding or LC–MS technology for pharmacokinetic (PK) assessments. CAR-T cell therapies involve administration of ‘living drugs’ capable of proliferation after infusion. This behavior is very different from conventional drug compounds, and the term ‘cellular kinetics’ was coined for in vivo ‘PK monitoring’ of both the expansion and persistence of the genetically engineered CAR-T cells.

The FDA’s Response to an Increase in the Development of Gene and Cell Therapies: What It Means for Sponsors

Jim Datin
Posted by Jim Datin / / Cell Therapy, Gene Therapy, Industry Update

The FDA has observed an unprecedented increase in the number of cell and gene therapy products entering the early stages of development. In a recent statement, the agency outlined new planned policies to help accelerate these innovations through the pipeline to clinical success. We discuss what this announcement means to sponsors.