2011 Webinars
CD34 Enumeration, How and When 2011 |
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November 16, 2011 CD34+ cell enumeration to assess the quality of stem cell transplants is still a subject for improvement. Although the CV values in different external quality assessment schemes of CD34 are decreasing during the last decade, as a result of standardization and education as well as better reagents and flow cytometers, in many stem cell laboratories this technique still needs attention. Generally, the determination of the number of CD34+ cells in fresh cell sources can be performed reliably. Yet there are differences using different reagents. The results are often worse in samples after cryopreservation and in samples with less than optimal viability. Mainly in these determinations the enumeration assay needs improvement. Therefore the applied methods, the used CD34 antibodies and fluorochromes, the gating procedure (especially the sequential back gating on CD45), the right use of 7-AAD when and application of the counting beads may introduce deviations. Additionally, the flow cytometer used as well as the calibration of lasers and PMTs, and the compensation of spectral overlap between fluorochromes may influence strongly the outcome of the determinations. The most important parameters and issues that will influence the final CD34 count will be discussed.
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hESC Manufacturing |
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November 9, 2011 Chair: Jon Rowley, PhD, Director, Cell Therapy R&D and Process Development Services Key Objectives:
Development of Scalable Manufacturing Processes for Human Embryonic Stem Cell (hESC) Derived Therapeutics Ralph Brandenberger, Ph.D. Director, Process Sciences, Geron Corporation hESC derived therapeutics offer one of the most promising opportunities in the future of biotechnology development. hESCs have the ability to both proliferate in culture and, under appropriate growth conditions, differentiate into lineage restricted cell types representative of all three primary germ layers: endoderm, mesoderm and ectoderm. As the first hESC derived cell therapies have entered early stage clinical trials, the development of scalable, clinically acceptable and financially viable bioprocesses to enable advanced clinical trials and eventual commercialization has become more important. Several technologies must be actualized to enable the scalable manufacture of hESC-based cell therapies. First, scalable production of hESCs must be developed to produce sufficient starting material for the production of the therapeutic cell population. Second, reproducible, refined, and scalable methods for differentiation of the hESCs to the targeted cell type must be developed. Finally, low cost production systems must be developed to ensure that hESC-based therapeutics can be accessed by all patients. This webinar will review the challenges, and opportunities, to developing scalable manufacturing processes for hESC derived cell therapies, and will present examples of Geron’s approaches to address these challenges. Pluripotent Stem Cell Processes Steve Oh, Ph.D. Principal Scientist, Bioprocessing Technology Institute, A*STAR The ability of human pluripotent stem cells (hESC and hiPSC) to differentiate to a variety of cell types generates a unique potential for the development of new cell based therapeutics and human based in vitro drug screening and testing. One of the issues that need to be resolved in order to develop these technologies is large scale, suspension stem cell bioprocessing. In this webinar, I will present several topics related to pluripotent stem cell manufacturing such as serum free media development, defined surfaces and different microcarriers for cell expansion and differentiation to human cardiomyocytes and neural stem cells. Cell yields are typically at least 3 times higher and more consistent when generated in the versatile microcarrier system compared to the 2D or embryoid body culture platforms; and the processes require much less manual interventions as the volumes increase. There is the added option of further improvement by optimization and control of environmental parameters. |
Potency Testing |
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November 2, 2011 Chair: William Janssen, Director, Cell Therapy Facility, H. Lee Moffitt Cancer Center Potency Testing Potency testing is often the most challenging aspect of cell therapy characterization, requiring understanding of the product’s biological function, which may involve interactions with other cell populations and other effects of the local microenvironment, and effective in vitro measurement of this function in a scientifically valid, controlled, timely manner. This webinar will review US and European regulatory requirements and guidance on potency testing for cell therapy products, including strategies for development and qualification of suitable functional assays. A case study presentation will provide practical examples of potency testing development, and will address the critical role of functional testing in comparability studies. Objectives:
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Placental Derived Mesenchymal Cells - Isolation, Processing and Characterization |
| September 14, 2011 9-10am Pacific; 12-1pm Eastern; 6-7pm CET Organized by the ISCT Lab Practices Committee Chair: Eugenia Ioannidi, PhD, Laboratory Supervisor, Stem Health Hellas, Greece
In recent years, scientists have revealed that the placenta is a valuable source of cells for research and development of cell therapies. Indeed, different cell populations which harbor both properties of stem/progenitor cells, as well as immunomodulatory properties, have been isolated and characterized from both human and animal placental tissues. Advances in this field have also prompted researches to investigate the potential effects of these cells in preclinical animal models of different diseases and clinical applications, with encouraging results obtained to date. This webinar will focus on the isolation, processing and characterization of placenta-derived cells, with special emphasis on mesenchymal stromal/stem cells that can be isolated from placental tissues. We will also address the most significant achievements to date in the field of placental cell-based therapeutic approaches. |
Emerging Issues in Cryopreservation for Cellular Therapies |
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June 15, 2011 9-10am Pacific; 12-1pm Eastern; 6-7pm CET Organized by the ISCT Legal and Regulatory Affairs Committee Speaker: Allison Hubel, PhD, Professor, University of Minnesota, Director, Biopreservation Core Resource. Learning Objectives of the Webinar:
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Software for Cellular Therapy Facilities: Homemade versus Commercial and why Facilities chose what they did |
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April 13, 2011 Chair: Sara Murray, BS, DAS, Manager, Hematopoietic Cell Processing Laboratory, Knight Cancer Institute, Oregon Health & Science University, Oregon, USA
Speakers:
William E. Janssen, PhD, Laboratory Director, Stem Cell Processing & Evaluation Laboratory, H. Lee Moffitt Cancer Center & Research Institute, Florida, USA
Darin Sumstad, MT (ASCP), Clinical Laboratory Scientist - Technical Lead, Cell Therapy Clinical Laboratory, University of Minnesota Medical Center, Fairview, Minnesota, USA
Webinar Overview:
In the Cellular Therapy field there is a growing need for productive software that permits a user to reference information, create documents and generate queries. Software’s ability to aggregate, link, harmonize and analyze data is essential when looking at improving transplant patient outcomes. There is also a growing need for software that meets the demands for regulatory compliance and demands of quality assurance within the Cellular Therapy field.
Software specifically designed for Cellular Therapy Facilities may be purchased directly from commercial software companies who specialize in medical informatics. Companies such as STEMSOFT and ComprehensiveBMT are examples of these. Facilities may also build their own unique databases using software provided by their Institution’s Microsoft Package. Examples of these include Microsoft Excel, Microsoft Sql Server and Microsoft Access.
There are a multitude of reasons to choose a specific type of software. Decision making often involves the software’s objectivity, functionality, diversity, user friendliness, presentation, overhead cost, etc.
Webinar learning objectives:
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Modified T-Cells: The implications of their use in the arenas of HIV and Cancer |
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March 16, 2011 9-10:30am Pacific; 12-1:30pm Eastern; 6-7:30pm CET Organized by the ISCT Legal and Regulatory Affairs Committee Chair: Shirley Bartido, QA Manager, Cell Therapy and Cell Engineering Facility, Memorial Sloan Kettering Cancer Center. Speakers: Dr. Bruce Levine, Associate Professor, Department of Pathology and Laboratory Medicine, University of Pennsylvania School of Medicine. Webinar Overview: "Strategies for Immune Reconstitution by Adoptive Transfer of Engineered T Cells in HIV" Bruce Levine, Ph.D. Associate Professor, Department of Pathology and Laboratory Medicine University of Pennsylvania School of Medicine Several gene therapy and genetic approaches have been investigated to build an HIV-resistant immune system through enhanced HIV-specific immunity, or engineering CD4 T cell resistance to HIV. Lessons learned in these investigations have applicability to novel cell and gene therapy approaches to other diseases including cancer "Engineering T cells for cancer immunotherapy" Isabelle Rivière, Ph.D Center for Cell Engineering, Molecular Pharmacology and Chemistry Program, Memorial Sloan-Kettering Cancer Center, New York, NY
T cells modified to express a second generation chimeric antigen receptor (CAR) specific to the B cell tumor antigen CD19 (19-28z) successfully eradicate systemic human CD19+ tumors in SCID-Beige mice. Based on these findings, two phase I clinical trials targeting autologous T cells with 19-28z CAR have been initiated at Memorial Sloan-Kettering Cancer Center to treat patients with chemotherapy-refractory chronic lymphocytic leukemia (CLL) (NCT00466531) and relapsed acute lymphoblastic leukemia (ALL) (NCT01044069). So far, 10 patients have been enrolled. Patients initially undergo a leukopheresis procedure in order to obtain T cells. Following activation with Dynabeads ClinExVivo™ CD3/CD28 beads, the T cells are transduced with the 19-28z CAR using cGMP gammaretroviral vector stocks generated in our facility. The T cells are expanded utilizing a Wave™ bioreactor platform that we validated. Data will be presented on manufacturing and release of genetically modified T cells as well as on clinical outcome in patients that were treated. |
Potency Testing |
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March 9, 2011 9-10am Pacific; 12-1pm Eastern; 6-7pm CET Organized by the ISCT Commercialization Committee Chair and Speakers: Webinar Overview: |
Vendor Qualifications |
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February 16, 2011 Chair: Michele Herman, MT(ASCP), Compliance Officer - Tranfusion Medicine, Beth Israel Deaconess Medical Center Learning Objectives:
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