From The Stage

Podcast Feature: Enabling the Breakthroughs of Tomorrow, Today

Jim Datin
Posted by Jim Datin / / 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

Dr. Arno Kromminga
Posted by Dr. Arno Kromminga / / 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.

What Drives BioAgilytix’s #TeamBehindtheScience?

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

What drives BioAgilytix’s #TeamBehindtheScience? Our own Thomas Corey Custer, Nora Freudenberger & Nathan Rudemiller discuss what led them to a scientific career & what propels them on a personal level.

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

Dr. Arno Kromminga
Posted by Dr. Arno Kromminga / / 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.

Platform Spotlight: ProteinSimple Ella™ for Accurate and Reproducible Multiplex Biomarker Analysis

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

When assessing biomarkers for multifactorial diseases, we ideally want to assess multiple analytes in the same experiment. That is where the value of multiplex biomarker analysis comes in – but this method also inherently creates potential challenges with cross-reactivity. We discuss how the ProteinSimple Ella platform enables multiplexing with excellent assay reproducibility, and how it can benefit studies with low sample volumes.