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.
What are the advantages of using the Biacore™ T200 SPR System for immunogenicity assessments with a tiered approach? Our experts discuss.
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 research use only (RUO) kits are used to support the biomarker analysis needed in clinical trials because both types of assays have different strengths and limitations. To select the appropriate kit requires an understanding of these pros and cons in the context of the intended study the assay must support.
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 MAb binding to a target protein which contained the dimerization interface – that is, until BioAgilytix stepped in.
There is no doubt that our genetic makeup is different. Yet surprisingly, biology is often an overlooked consideration in ensuring biomarker assays are set up and validated to support the intended study.
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 to help us deliver both high quality science and service? In this Q&A session, we talk with Mike Losauro, Senior Business Development Director at BioAgilytix, about how he applies his scientific background to his role today.
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 highlights the critical questions that were answered.
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. To continue this progress, it is important that we understand the key principles and events in gene therapy’s history that have led us to where we are today.
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.
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.
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.
Services
Platforms
