Investigating the Immunogenic Potential of Variations in Host Cell Protein Levels in Clinical-Grade AAV8 Products
HCP impurities were of low complexity, but pronounced variations in their abundance were observed between lots. High HCP levels were not overtly immunogenic in vivo and in vitro. However, despite statistical limitations, they seemed to be associated with increased CRA. Thus, a negative effect of high HCP levels on retinal tolerability could not be ruled out.
Authors
- Karl Ulrich Bartz‐Schmidt (ORCID: https://orcid.org/0000-0001-8031-7478)
- Stylianos Michalakis (ORCID: https://orcid.org/0000-0001-5092-9238)
- Kirsten Bucher (ORCID: https://orcid.org/0000-0003-4746-6337)
- Immanuel P. Seitz (ORCID: https://orcid.org/0000-0002-3086-6425)
- Eduardo Rodríguez‐Bocanegra (ORCID: https://orcid.org/0000-0003-3019-8911)
- Felix F. Reichel (ORCID: https://orcid.org/0000-0001-9325-5616)
- Bernd Wissinger
- Martin Biel (ORCID: https://orcid.org/0000-0002-9974-3052)
- Tobias Peters (ORCID: https://orcid.org/0000-0002-9187-4904)
- M. Dominik Fischer (ORCID: https://orcid.org/0000-0002-0690-6538)
- Dimitri Romanovsky
Institutions
- LMU Klinikum (DE)
- University of Oxford (GB)
- Oxford University Hospitals NHS Trust (GB)
- Ludwig-Maximilians-Universität München (DE)
Publication Details
- Journal
- Investigative Ophthalmology & Visual Science
- Published
- 2025-06-11
- DOI
- https://doi.org/10.1167/iovs.66.6.38
- Citations
- 1
- Primary Topic
- Virus-based gene therapy research
- Type
- article
- Field-Weighted Citation Impact
- 1.82
Funders
- Biogen
- Astellas Pharma