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.
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.
In our latest Team Q&A blog, we talk to Charlie Walker, Associate Director of Finance at BioAgilytix, to learn more about his role, why he felt drawn to the bioanalytical industry, and how he gets to see the team’s work play out in exciting ways, and for the benefit of patients in need.
Flow cytometry is an ideal platform for many applications involving the study of complex cell populations. In the first blog of our new “The Fit for Flow” series, we discuss what makes flow cytometry the platform of choice for receptor occupancy (RO) studies.
Our latest Team Q&A blog features Dr. Corinna Fiorotti, our recently promoted Scientific Officer and Key Accounts Director. Read how she applies her extensive background experience in the lab to her customer-facing role with BioAgilytix today.
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.
Couldn’t make the Oxford Global’s 14th Annual Biomarkers Congress? Read our recap of the key opportunities and challenges in biomarker development that scientists discussed.
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