Validating flow cytometry assays for cell and gene therapies
As cell and gene therapies are becoming increasingly important for the treatment of cancers and other diseases, the need for reliable characterization of such therapies is skyrocketing.
Flow cytometry has emerged as a key methodology for the analysis of cell and gene therapies during research, clinical manufacturing and follow-up in patients. However, reproducibility of results is often hampered by a lack of operator experience, quality reagents and stable instruments, as well as regulatory guidance on essential reagent, instrument and software requirements. Additionally, scientists often find themselves completely on their own when it comes to assay qualification and validation for clinical trials.
Join Zhaojun Yin, Senior Scientist at Genentech (CA, USA) and Marsilius Mues, R&D Group Leader at Miltenyi Biotec (Bergisch Gladbach, Germany) in this webinar to learn about how they approach assay qualification and validation and what they consider for reliable flow cytometry analytics of cell and gene therapeutic products.
What will you learn?
- How to develop and validate flow cytometry based cellular kinetics assays for T-cell receptor (TCR) engineered T cells.
- How to standardize your assays with multi-instrument harmonization, automated data analysis and recombinantly-engineered antibodies (in a dried-down format).
Who may this interest?
- Cell and gene therapy bioanalysts
- Pharmaceutical and biotech professionals
- Oncology scientists and immunologists
Speakers
Zhaojun Yin
Senior Scientist, BioAnalytical Sciences
Genentech (CA, USA)
Dr Zhaojun Yin is a Senior Scientist at Genentech in the BioAnalytical Sciences Department. He supports the in vitro biological characterization of large molecules with Fc-mediated effector function assays. He also leads the development of immunogenicity assays, including NAb and immunogenicity risk ranking assays and cellular kinetics assays for TCR-T cell products using flow cytometry.
Marsilius Mues
R&D Group Leader at Miltenyi Biotec
Miltenyi Biotec (Bergisch Gladbach, Germany)
Dr Mues joined the R&D Department of Miltenyi Biotec in 2017. He currently leads interdisciplinary research and development in the field of immuno-oncology and cellular therapeutics, with a focus on CAR T cell engineering for personalized immunotherapy.
He oversees the establishment of multiparametric immune assays for functional characterization of engineered T cells, along with automated data acquisition and analysis tools for translational research, cell therapy manufacturing and patient immune monitoring during clinical trials.
He conducted his PhD studies at the Max Planck Institute of Neurobiology (Munich, Germany) on T cell signaling during autoimmune disease and completed his postdoctoral research at UCSF (CA, USA), where he focused on novel combinatorial therapies using high-complexity lentiviral shRNA & CRISPR/Cas9 libraries for T cell leukemia.
In association with
