BioAgilytix Team Q&A: Meet Janett Schwarz, Principal Investigator at BioAgilytix
BioAgilytix’s team features a plethora of talented scientists with well-rounded experience and expertise. While some of these individuals have remained stationed in...
Event Line-Up: The Bioanalytical Industry Forums We’ll Be at This Fall
We’re looking forward to participating in several upcoming bioanalytical conferences and events this fall, ranging from small-circle workshops to global,...
BioAgilytix Team Q&A: Meet Eric Nesbit, Bioanalytical Project Manager/Scientist III
To better understand how BioAgilytix is able to deliver premier bioanalytical services, it is important to get to know the people behind our science. In this Q&A...
Meet Jelle Hempenius, Business Development Director, Europe
Did you know that BioAgilytix’s ‘deep bench’ extends beyond those we have working in the lab? Many individuals in our operational departments, from business...
Gene Therapy Trends: Conditional Approval of Zynteglo Brings Ex Vivo Gene Therapy Into Focus
In June, the European Medicines Agency (EMA) granted a conditional approval to the orphan drug Zynteglo, the first gene therapy approved for the treatment of a rare...
C-Path “Points to Consider Document” Clarifies Bioanalytical Assay Validation in Support of Clinical Biomarker Qualification
I had the great privilege to serve as a contributing author to the Critical Path Institute (C-Path)’s “Points to Consider Document” on Scientific and Regulatory...
Platform Spotlight: ImmunoCAP to Support Diagnosis of Allergic Reactions Against Biologics
Ultimately, all biologicals are immunogenic leading to the formation of anti-drug antibodies (ADA). In most cases, these antibodies are of IgG isotype. In some cases...
Immunogenicity Assessment Using the Biacore™ T200 SPR System
By PD Dr. Arno Kromminga & Dr. Daniel Worms
All therapeutic proteins have the potential to induce an immune response that can lead to the formation of anti-drug...
510K Approved Assays vs. RUO Assays: Which Best Support Clinical Trial Biomarker Studies?
The answer to the question is “it depends”. Commonly a combination of 510K approved kits (in Europe known as assays that need to follow IVD-directive 2017/746) and...
To the Rescue: Applying a Novel Approach to Minimize False Positive ADA Assay Results
Immunogenicity assessment equips us with important information on the safety and efficacy of a drug candidate for its intended patient population, and is needed to...