Case Studies in Cell & Gene Therapy Process Optimization

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Supported by:
Fresnius
Hear from leading expert Dr David DiGiusto, Stanford University School of Medicine, USA, as he shares his extensive experience in developing and optimizing manufacturing processes for cell and gene therapy products including:

    • The unique challenges of utilizing different cell types such as bi-specific CAR-T cells, regulatory T cells and hematopoietic stem cells.
    • Specific approaches taken to overcome these challenges including optimizing cell processing steps such as isolation, washing, expansion, enrichment, labelling and purification.
    • Addressing the complex and labor-intensive manufacture of viral vectors, with a specific focus on AAV.
    • First hand experience of implementing automated solutions across the cell and gene therapy manufacturing pathway.

This is followed by a presentation by Dr Alaina Schlinker, Fresenius Kabi, as she discusses practical approaches to addressing some of the key processing challenges for cell and gene therapy products.

The remainder of the webinar is a Q&A session with both Dr DiGiusto and Dr Schlinker sharing their perspective on the critical issues around manufacture of cell and gene therapies.

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Dr David DiGiusto

Executive Director – Stem Cells and Cellular Therapeutics Operations, Stanford University School of Medicine, USADavid DiGiustoDr David DiGiusto is the Executive Director of Stem Cell and Cellular Therapeutic Operations for Stanford Hospital and Clinics and a Senior Academic Researcher in the Division of Stem Cell Transplantation and Regenerative Medicine at Stanford University. He has over 25 years of experience in the scientific, clinical and regulatory aspects of cells as therapeutic agents including the isolation, characterization and genetic modification of hematopoietic stem cells and T-cells for clinical applications. He has been instrumental in the creation of 6 GMP compliant biologics manufacturing facilities and associated quality systems, production and QC testing programs. Under his direction, plasmid DNA, CAR-T-cells, regulatory T-cells, engineered stem cell grafts and gene modified hematopoietic stem cell products have been manufactured and released for use in Phase I/II clinical trials. Dr DiGiusto is a major contributor to first in human (and other ongoing) studies for Cancer and HIV Gene Therapy and has developed methods for assessing ex-vivo stem cell manipulations using in vitro and in vivo models. His laboratory (The Laboratory for Cell and Gene Medicine) specializes in the development of manufacturing processes and QC assays and provides cGMP compliant clinical materials production and regulatory support activities for investigational cell products.

Dr Alaina Schlinker

Manager, Cell Therapy Application Support, Fresenius Kabi, USAAlaina Schlinker
Alaina manages application support for the Lovo Cell Processing System at Fresnius Kabi where she has worked since 2014. She obtained her PhD from Northwestern University where she conducted research into platelet generation from hematopoeitic stem cells.