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…
The Fit for Flow Cytometry, Part 1: Ideal for Receptor Occupancy Assessment
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…
New FDA Guidance on Developing and Validating Assays for ADA Detection: Key Updates and Clarifications
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…
Key Takeaways from Oxford Global’s 14th Annual Biomarkers Congress
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.
Supporting a Gene Therapy Clinical Trial with Assay to Measure NAbs Against the AAV9 Serotype
Today we're featuring a case study on how BioAgilytix developed a cell-based assay to determine the prevalence of pre-existing antibodies against the AAV9 serotype in…
The FDA’s Response to an Increase in the Development of Gene and Cell Therapies: What It Means for Sponsors
...material, gene therapy uses DNA to manipulate a patient’s cells to compensate for abnormal genes or to make a beneficial protein, and cell therapy…
Ligand-Binding Assay Optimization, Part 1: Critical Attributes of Platforms Used
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…
BioAgilytix Partnership Across Continents: Meet William Hunter and Todd Lester
With headquarters in the USA and Europe, effective team-wide communication is critical to our success. William Hunter, Director of BD & Global Key Accounts at…