From The Stage

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.

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

Jim Datin
Posted by Jim Datin / / 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.

BioAgilytix Team Q&A: Meet David Rusnak, Director of Laboratory Systems and Automation at BioAgilytix

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

In this Q&A session we talk to David Rusnak, one of the first 3 employees to join BioAgilytix when it was founded 10 years ago and currently our Director of Laboratory Systems and Automation, to learn more about his experience growing with the organization from its very start – and what still keeps him excited to come to work each day.

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.

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

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

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / 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…