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Tag: Immunogenicity

Impact of Pre-Existing Immunogenicity Against AAV on Gene Therapy Trials

The concept of using pre-existing immunogenicity as an exclusion criteria for gene therapy clinical trials is changing. BioAgilytix’s Chief Scientific Officer, Dr. Jim McNally, explores…

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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…

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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…

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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…

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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

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Biomarkers and Immunogenicity in the Spotlight at the 2016 10th Workshop on Recent Issues in Bioanalysis

The whitepaper based on discussions at the 10th Workshop on Recent Issues in Bioanalysis (WRIB) has been published! Everyone who participated, are very excited to…

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