Case studies in cell & gene therapy process optimization
On demand

Case studies in cell & gene therapy process optimization

Thursday 08:00 PST / 11:00 EST / 16:00 GMT / 17:00 CET
Case studies in cell & gene therapy process optimization

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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David DiGiusto
David DiGiusto
Chief Technology Officer, Cell and Gene Therapy, ‎Resilience at Semma Therapeutics
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.
Alaina Schlinker
Alaina Schlinker
Senior Manager, Cell Therapy Application Support at Fresenius Kabi

Alaina Schlinker has provided application support for the LOVO Cell Processing System since its commercial launch in June 2014. Alaina and her team work with customers to optimize the LOVO Cell Processing System to meet specific applications throughout the cell therapy manufacturing workflow. Alaina’s team alsoworks closely with the Fresenius Kabi R&D group, collaborating to bring customer feedback and Fresenius Kabi’s core competencies together in the development of new technology.

Alaina has degrees in chemical engineering (BS from University of Southern California and PhD from Northwestern University). Her thesis research focused on in vitro platelet production from CD34+ stem and progenitor cells as alternative source of platelets for patients.