Big pharma case study: alpha testing of a generic anti-AAV kit and comparison to in-house methods
Jan
30
2025
Upcoming webinar

Big pharma case study: alpha testing of a generic anti-AAV kit and comparison to in-house methods

Thursday 08:00 PST / 11:00 EST / 16:00 GMT / 17:00 CET
Sponsor
Big pharma case study: alpha testing of a generic anti-AAV kit and comparison to in-house methods

Gene delivery via AAV vectors has emerged as a pivotal technology in the clinical treatment of human diseases. The non-pathogenic viruses transduce cells, leading to a long-term expression of clinically relevant transgenes. However, due to the high prevalence of anti-AAV antibodies from prior exposure to the non-pathogenic wildtype AAV, which can diminish the effectiveness of the therapy, testing is necessary to assess levels of pre-existing AAV immunogenicity antibodies for individual candidates included in clinical trials.

This webinar will present a case study from Bayer comparing a commercially, generic anti-AAV assay run on an automatic immunoassay platform designed to detect anti-AAV antibodies in human and cynomolgus monkey matrices with results obtained from in-house validated ELISA plate assays. Both human and monkey serum samples were tested using the generic anti-AAV assay to determine the levels of pre-existing AAV-antibodies for 2 different AAV serotypes. By utilizing cut-point validation, individual samples were ranked as anti-AAV antibody positive or negative in both assays and the results were directly compared.?The speakers will compare the ranking profiles obtained from the two alternative assays to identify the optimal tool for investigating levels of pre-existing AAV-8 and AAV-9 antibodies in human and monkey matrices.

Attend this webinar to:

  • Learn how to optimize pre-existing anti-AAV antibody analysis of candidates for nonclinical and clinical studies
  • Assess comparative case studies around detection of anti-AAV8 and -AAV9 antibodies in human and monkey serum samples
  • Compare and contrast the performance of traditional ELISA plate-based assays with an automatic immunoassay platform approach in anti-AAV antibody quantification across multiple serotypes
Kira Hedström
Kira Hedström
Application Scientist at Gyros Protein Technologies

Kira Hedström is an Application Scientist with the R&D team, at Gyros Protein Technologies, specializing in cell and gene therapy applications. She has worked on assay projects for various gene therapy vectors, including AAV and exosomes. Kira has a MSc in Synthetic Biology and Biotechnology from the University of Edinburgh, with expertise in Regenerative medicine and genetic engineering. She has spent 3 years as a consultant at various immunoassay companies, including Thermo Fisher, Cytiva, and Biovica, and has a broad insight into the assay development process.

Eva-Maria Thüring
Eva-Maria Thüring
Postdoc, Bioanalytical Department at Bayer

Dr. Eva-Maria Thüring holds a PhD in Biology, which she received from the University of Münster. In her doctoral thesis she identified and characterized the role of the tumor suppressor TMIGD1 in colorectal cancer by employing new assay formats based on intestinal organoids and 2D-enteroids. In her master project, which she conducted at the Max-Planck-Institute in Dortmund, she was part of a front runner team that developed a new protein interaction assay in living cells. Through these projects she gained expertise in implementing novel methodologies and assay techniques in biochemical- and molecular biology-oriented laboratories. Since December 2023, Eva works as a Post-Doc at Bayer in the bioanalytics department of the Research and Development Center in Wuppertal, Germany. There she uses her expertise to establish new analytical methods that primarily serve the bioanalysis of new nucleotide-based drug candidates.

2013-2017: Bachelor of Science in Chemical Biology (Technische Universität Dortmund, Max-Planck-Institute for Molecular Physiology)

2017-2019: Master of Science in Chemical Biology (Technische Universität Dortmund, Max-Planck-Institute for Molecular Physiology)

2020-2023: Doctorate (Ph.D.) (University of Münster (WWU), Institute of Medical Biochemistry) (Thesis: “New Insights into PDZ-mediated Interactions of the Cell Adhesion Receptor and Tumor Suppressor TMIGD1”)

Since Dezember 2023: Post-Doc at Bayer in the Ligand-Binding-Assay, Bioanalytic Department in Wuppertal, Germany

in 11
Days

SPEAKERS

Kira Hedström
Kira Hedström
Application Scientist at Gyros Protein Technologies
Eva-Maria Thüring
Eva-Maria Thüring
Postdoc, Bioanalytical Department at Bayer

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