C-Path “Points to Consider Document” Clarifies Bioanalytical Assay Validation in Support of Clinical Biomarker Qualification
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…
Platform Spotlight: ImmunoCAP to Support Diagnosis of Allergic Reactions Against Biologics
The observation of drug-specific IgE antibodies which may cause anaphylaxis prompts the need to test for these antibodies - but because IgE are 2000-fold less…
Immunogenicity Assessment Using the Biacore™ T200 SPR System
What are the advantages of using the Biacore™ T200 SPR System for immunogenicity assessments with a tiered approach? Our experts discuss.
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…
To the Rescue: Applying a Novel Approach to Minimize False Positive ADA Assay Results
Target interference can cause false positive ADA assay results and stall out promising drugs. This could have been the case for one study involving an…
BioAgilytix Team Q&A: Meet Mike Losauro, Senior Business Development Director at BioAgilytix
Did you know that many of our team members have cross-functional background experience both in the lab and in customer-facing roles, making them uniquely equipped…
Your Questions About Immunogenicity Assessment of Gene Therapy Compounds Answered
The webinar I recently hosted with my colleague Lydia Michaut explored key challenges and trends in the immunogenicity assessment of gene therapy compounds. This recap…
A History of Gene Therapy: Exploring Lessons Learned In Light of New Approvals
The FDA recently approved the first gene therapy for pediatric patients with SMA, signifying a major step forward for the therapeutic field as a whole.…
Key Takeaways from the 13th Annual WRIB, 2019
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 Assessment of Gene Therapy Compounds
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…