Quality Control of Manipulated and Cryopreserved Grafts
Organized by the Laboratory Practices Committee
Chair: Michele W. Sugrue M.S., MT(ASCP)SBB, Coordinator, Research Programs
Division of Hematology/Oncology, Department of Medicine, University of Florida Shands Cancer Center, USA
Ulrike Koehl, PhD, University Hospital, Paediatric Haematology and Oncology, Head, Lab Stem Cell Transplantation and Immunotherapy, Frankfurt, Germany
Lubomir Arseniev, MD, Site Manager, Head Quality Control, Cellular Therapy Centre - Medical School Hannover, Germany
About the Webinar:
The quality control of manipulated and/or cryopreserved grafts has been a hot topic since the beginning of the haematopoietic cell transplantation. Both scientific societies and competent authorities are investing more and more efforts with regard to establishing essential requirements and standardisation of manufacturing and quality control processes.
Where donor eligibility approval is quite well defined, a variety of further questions still seem to be not formally established: overall and subset cell counting, potency assays, control algorithm, e.g. in process and final controls etc.
This webinar will provide information on validation requirements and procedures for quality control methods as well as on quality control data of manipulated (selection, depletion) and/or frozen grafts. In order to improve release criteria for new cellular therapy products (e.g. Biologics or ATMP) multi-colour flow cytometry analyses will be provided. This webinar will discuss the specific challenges and outline practices regarding appropriate definition of a quality control panel. The goal of this presentation is to further pursue discussion within this topic.
This product is a downloadable PDF and provides a link to an mp4 video recording of the webinar.