From The Stage

C-Path “Points to Consider Document” Clarifies Bioanalytical Assay Validation in Support of Clinical Biomarker Qualification

Posted by / / Biomarkers, Industry Update

A contributing author to the Critical Path Institute (C-Path)’s “Points to Consider Document,” Dr. Afshin Safavi summarizes considerations outlined in the paper designed to establish consensus on the expectations for the validation of assays used in the regulatory qualification of fluid biomarkers.

Key Takeaways from the 13th Annual WRIB, 2019

Posted by / / BioAgilytix Insight, Industry Update

Last month at WRIB, our scientific team had the opportunity to participate in a number of discussions surrounding the latest topics of interest in biomarkers, immunogenicity, and regulatory standards. We wanted to share some of the event takeaways we found most interesting and valuable.

Podcast Feature: Enabling the Breakthroughs of Tomorrow, Today

Posted by / / CRO Selection, Industry Update

BioAgilytix’s President and CEO, Jim Datin, sat down to discuss the exciting growth trends in large molecule development, and how BioAgilytix is growing in kind to support the increased need for specialized bioanalysis to accelerate these innovative therapies to market.

Immunogenicity Assessment of Gene Therapy Compounds

Posted by / / Gene Therapy, Industry Update

By Dr. Arno Kromminga and Dr. Lydia Michaut
Gene therapy has experienced an exciting resurgence in the post-genomic era, but unwanted immunogenicity is still a concern. Our latest blog gives insight into the current concepts for designing an immunogenicity assessment strategy fitting the specific needs of a given gene therapy compound.

New FDA Guidance on Developing and Validating Assays for ADA Detection: Key Updates and Clarifications

Posted by / / Immunogenicity, Industry Update

The FDA’s recently released new guidance, designed to facilitate development and validation of assays for the detection of anti-drug antibodies for immunogenicity testing, includes several needed revisions and clarifications. Our own immunogenicity expert, Dr. Arno Kromminga, outlines the significant updates made.

A Dose of Pharma and Biotech News: February 13, 2019

Posted by / / Biomarkers, Industry Update

We find it critical to stay on top of the latest industry developments to inform our own work and help our customers best address emerging bioanalytical challenges and opportunities; we've compiled some of our favorite recent industry articles of interest to share with you.

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.

CBI and The Prion Alliance at the Broad Institute Collaboration

Posted by / / Industry Update

We are privileged to be working in collaboration with representatives of the Prion Alliance at the Broad Institute, on the development of a Prion ELISA. Why would we include this story in our blog? Well, it is because two aspects of this project are noteworthy; read on.