ISCT Webinars from 2011

CD34 Enumeration, How and When 2011

November 16, 2011
9-10am Pacific; 12-1pm Eastern; 6-7pm CET
Organized by the ISCT Lab Practices Committee

Chair and Speaker: Varda Deutsch, PhD, Hematology Laboratory Director, Tel-Aviv Sourasky Medical Center

Speaker: Frank Preijers, PhD, Stem Cell Laboratory Director/Head section Immunophenotyping, Radboud University Nijmegen Medical Center

Summary:

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.


Objectives:

  • Review methods and guidance documents for CD 34 enumeration in grafts.
  • Discuss reagents, gating, viability testing, fluorochromes and overlap between fluorochromes, calibration of lasers and problematic samples.
  • Emphasize the most important issues that influence the final CD34+ cell counts.
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hESC Manufacturing

November 9, 2011
8-9am Pacific; 11am-12pm Eastern; 5-6pm CET
Organized by the ISCT Commercialization Committee

Chair: Jon Rowley, PhD, Director, Cell Therapy R&D and Process Development Services

Speaker: Ralf Brandenburger, PhD, Director, Process Sciences, Geron Corporation

Steve Oh, MEng, CEng, CSci, MIChemE, Associate Director and Principal Scientist, Bioprocessing Technology Institute, A*STAR.

Key Objectives:

  • What are human embryonic stem cell derived cell therapies?
  • What are the challenges to scalable manufacture of hESC derived cell therapies?
  • What are some of the new approaches to address these challenges?

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.

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Potency Testing

November 2, 2011
9-10am Pacific; 12-1pm Eastern; 5-6pm CET
Organized by the ISCT Legal and Regulatory Affairs Committee

Chair: William Janssen, Director, Cell Therapy Facility, H. Lee Moffitt Cancer Center

Speakers: Scott Burger, Principal, Advanced Cell and Gene Therapy

Christopher Bravery, Director, Consulting on Advanced Biologicals Ltd.

Summary:

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:

  • Review US FDA and EMA regulatory requirements and guidance documents for potency testing of cell-based products
  • Discuss potency assay development and qualification, and use in lot release
  • Effective use of functional assays in comparability studies

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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

Speaker: Ornella Parolini, PhD, Director, Research Centre E.Menni, Fondazione Poliambulanza, Brescia, Italy

Learning Objectives:
  • Provide a basic overview of the normal developmental biology of the human placenta.
  • Provide a basic description of the structure of different placental regions.
  • Describe and discuss the methods used to isolate stem/progenitor cells from different placental tissues.
  • Discuss methods and results regarding the characterization of placenta-derived cells through in vitro studies, in terms of: phenotype, differentiation potential, immunomodulatory properties.
  • Discuss emerging insights on preclinical studies with placenta-derived cells.
Overview:

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.

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Emerging Issues in Cryopreservation for Cellular Therapies

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:

  • To understand the role of preservation in cell therapy.
  • Describe and characterize the manner by which changes in therapeutic applications may influence preservation protocols.
  • Describe new and emerging systems of therapeutic value to be preserved.
  • Describe new and emerging approaches to preservation of cell therapies


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Software for Cellular Therapy Facilities: Homemade versus Commercial and why Facilities chose what they did

April 13, 2011
9-10am Pacific; 12-1pm Eastern; 5-6pm BST, 6-7pm CET
Organized by the ISCT Lab Practices Committee


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:

  1. Discuss what type of software different Cellular Therapy Facilities use.
  2. Discuss the pros and cons of the software choice.

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Modified T-Cells: The implications of their use in the arenas of HIV and Cancer

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.

Dr. Isabelle Rivière, Director, Cell Therapy and Cell Engineering Facility, Memorial Sloan Kettering Cancer Center.

Webinar Overview:

Gene-modified T cells were the first gene therapy tool used in clinical gene transfer trials. After the first applications in immunodeficiency diseases, T cell gene therapy has been extended to HIV infection and cancer. In this Webinar, two experts will provide their insights in this cutting edge field.

"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.


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Potency Testing

March 9, 2011

9-10am Pacific; 12-1pm Eastern; 6-7pm CET

Organized by the ISCT Commercialization Committee

Chair and Speakers:

Scott Burger, Principal, Advanced Cell and Gene Therapy
Christopher Bravery, Director, Consulting on Advanced Biologicals Ltd.

Webinar Overview:

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:
• Review US FDA and EMA regulatory requirements and guidance documents for potency testing of cell-based products.
• Discuss potency assay development and qualification, and use in lot release.
• Effective use of functional assays in comparability studies.


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Vendor Qualifications

February 16, 2011
9-10am Pacific; 12-1pm Eastern
Organized by the ISCT Laboratory Practices Committee

Chair:

Deborah Lamontagne, MLS(ASCP),Stem Cell Laboratory Tech Leader, Harvard University

Speakers:

Michele Herman, MT(ASCP), Compliance Officer - Tranfusion Medicine, Beth Israel Deaconess Medical Center
Andrew Havens, Quality Assurance Manager, University of Utah Cell Therapy Facility

Learning Objectives:

  1. Review regulatory & accreditation requirements for vendor qualification.

  2. Decribe basic process for qualification of a critical service provider.

  3. Describe basic overview of steps involved in performing a site visit.

  4. Discuss supply/reagent scoring.

  5. Describe the system used at a Cell Therapy Facility and how it provides a structured way to identify critical supplies/reagents. Show how a scoring system can directly correlate to what type of vendor qualification is required.

  6. Discuss how to perform qualifications with vendors without a site visit.


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