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.…
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…
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…