From The Stage

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

Posted by / / 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.

BioAgilytix Team Q&A: Meet Gabi Schewe, Lab Manager at BioAgilytix Europe

Posted by / / BioAgilytix Insight, CRO Selection

In this Q&A session, we speak to longtime BioAgilytix Europe team member Gabi Schewe – who has been with the company since its founding as IPM Biotech in 1996 – to hear about the exciting and historic scientific advancements she has been part of with the company and what she believes has made its long-term success possible.

Ligand-Binding Assay Optimization, Part 1: Critical Attributes of Platforms Used

Posted by / / Bioanalytical Platforms

Consistent discussion and improvement upon the standard practices of bioanalytical laboratories is critical to improving the work we do supporting innovative biologics development in the long-term. One of the rapidly advancing areas that is being regularly discussed in the industry is the evolution of ligand-binding assay (LBA) platforms. In this blog, I will summarize best practices and characteristics associated with LBA platforms as well as the features these platforms absolutely need to enable scientists to respond to industry pressures that drive demand for increasingly complex bioanalysis, condensed timelines, and continued…