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International


Cell and Gene Therapy General

Publications:

• Burger SR. 2004. Cell and Gene Therapy - Challenges and Strategies for an Emerging Industry. Cell and Gene Therapy 5:9-14.
• Burger SR. 2003. GTP/GMP cell engineering for cell and gene therapies. BioProcessing 2:66-69.
• Burger SR, et al. 2003. Cellular engineering of HSV-tk-transduced, expanded T-lymphocytes for GVHD management. Acta Haematologica 110:121-131.
• Burger SR. 2002. Advanced cell and gene therapies: translational development and GMP production. BioProcessing 1:19-23. [Article]
• Burger SR. 2001. Umbilical cord blood stem cells. In Handbook of Transfusion Medicine, (C.D. Hillyer, et al., eds.). Academic Press, San Diego.
• Burger SR, et al. 1999. Development of an infusible-grade solution for non-cryopreserved hematopoietic cell storage. Cytotherapy 1:123-133.

Presentations:

• Burger SR. 2007. Overcoming Comparability and Scale-up Challenges in Cell Therapy and Tissue Engineered Product Commercialization. Phacilitate Cell & Gene Therapy Forum
• Burger SR. 2005. Commercialization of Cell and Gene Therapy Products: When and How. Phacilitate Cell and Gene Therapy Forum
• Burger SR. 2003. Development and GTP/GMP Production of Novel Cell and Gene Therapies. Mayo Clinic
• Burger SR. 2002. Translational development and GMP/GTP production of advanced cell and gene therapies. Japanese Society of Hematology-Japanese Society of Clinical Hematology joint annual meeting.
• Burger SR. 2002. Development, Production, and Regulation of Cell Therapy Products. Dendreon Corporation
• Burger SR. 2002. Advanced cellular therapies: translational development and GMP/GTP production. International Society for Pharmaceutical Engineering annual meeting.
• Burger SR. 2002. Novel Cell, Gene, and Tissue Therapies: Issues In Development and GMP Production. Cell and Tissue BioProcessing conference • Burger SR. 2001. Advanced Cellular Therapies. National Marrow Donor Program.
• Burger SR. 2001. Immune Effector Cell Therapies: Donor Lymphocyte Infusions and Tumor Cell Vaccines. AABB/ISHAGE audioconference.


Development and GMP/GTP Manufacturing

Publications:

• Burger SR. 2003. GTP/GMP cell engineering for cell and gene therapies. BioProcessing 2:66-69.
• Burger SR. 2002. Advanced cell and gene therapies: translational development and GMP production. BioProcessing 1:19-23.

QC Testing

Presentations:

• Burger SR. 2006. Translational Development: From Bench, to Clinic, to Commercial Manufacture. IBC Life Sciences Gene Therapy Conference
• Burger SR. 2006. Cell Therapy Products: Translational Development and Manufacturing. Harvard Center for Human Cell Therapy
• Burger SR. 2006. Manufacturing Cell and Gene Therapy Products. Center for the Engineering of Living Tissues, Georgia Institute of Technology/Emory University
• Burger SR. 2006. Options for Manufacturing Cell Therapy Products. Speaker and session chair, Phacilitate Cell & Gene Therapy Forum
• Burger SR. 2005. Manufacturing Cell and Gene Therapy Products: Overcoming the Obstacles. Cambridge Healthtech Institute Stem Cell Research Conference
• Burger SR. 2005. Manufacturing Cell Therapy Products - Challenges and Opportunities. GE Healthcare Cell Technologies Science Programme
• Burger SR. 2005. Developing Cell Therapy Product Manufacturing: Avoiding The Pitfalls. International Society for Cellular Therapy 2005 Annual Meeting
• Burger SR. 2005. Strategies for Manufacturing Cell Therapy Products. Johnson & Johnson Cell Therapy and Regenerative Medicine Task Force
• Burger SR. 2003. Development and GTP/GMP Production of Novel Cell and Gene Therapies. Mayo Clinic
• Burger SR. 2002. Translational development and GMP/GTP production of advanced cell and gene therapies. Japanese Society of Hematology-Japanese Society of Clinical Hematology joint annual meeting. • Burger SR. 2002. Development, Production, and Regulation of Cell Therapy Products. Dendreon Corporation
• Burger SR. 2002. Advanced cellular therapies: translational development and GMP/GTP production. International Society for Pharmaceutical Engineering annual meeting.
• Burger SR. 2002. Novel Cell, Gene, and Tissue Therapies: Issues In Development and GMP Production. Cell and Tissue BioProcessing conference

Regulatory Compliance, GMPs, GTPs, and GCPs, Quality

Publications:

• Burger SR. 2003. Current regulatory issues in cell and tissue therapy. Cytotherapy 5:289 298.
• Burger SR. 2003. Issues in implementing gene therapy clinical studies. Cytotherapy (in press).
• Burger SR. 2000. Design and operation of a cGMP cell engineering laboratory. Cytotherapy 2:111-22.

Presentations:

• Burger SR. 2006. Regulations and Standards for Cell Therapy - International Perspective. Somatic Cell Therapy Annual Meeting
• Edward K. 2006. Product Release. Somatic Cell Meeting
• Edward K. 2006. Unrelated Product Quality Issues. ISCT Annual Meeting
• Edward K. 2005. Donor Eligibility Final Rule. AABB Annual Meeting
• Burger SR. 2005. Regulatory Pathway for Cell Therapy Products. Stem Cells for Treatment of Neurological Diseases. BIO 2005 Annual Meeting
• Burger SR. 2005. Steps Toward Compliance - Laboratory Practices and Regulatory Affairs Workshop. International Society for Cellular Therapy 2005 Annual Meeting
• Burger SR. 2003. Stem Cell Processing and GTP Regulations. National Marrow Donor Program
• Burger SR. 2003. GMP/GTP Cell Engineering for Hematopoietic Cell Therapies. Georgetown University Medical Center audioconference.
• Burger SR. 2002. Cell Therapy GMP Production Facilities. Facilities for Mammalian Cell Products conference
• Burger SR. 2001. Overview of Validation. ISHAGE GMP workshop.
• Burger SR. 2001. Overview of Good Clinical Practices. Somatic Cell Therapy meeting.
• Burger SR. 2001. Quality for Advanced Cellular Therapies. BioWhittaker Quality Day.
• Burger SR. 2000. Product Release Testing In GMP Cellular Engineering. American Association of Blood Banks annual meeting
• Burger SR. 2000. Equipment and Software Validation and Monitoring. ISHAGE GMP workshop
• Burger SR, et al. 1999. Development of a computer software system for graft engineering II. ISHAGE annual meeting. Cytotherapy 1:219.
• Burger SR, et al. 1998. Development of a computer software system for graft engineering. ISHAGE annual meeting. J. Hematotherapy 7:275.


Gene Therapy, Immunotherapy, Stem Cells

Publications:

• Burger SR. 2001. Umbilical cord blood stem cells. In Handbook of Transfusion Medicine, (C.D. Hillyer, et al., eds.). Academic Press, San Diego.
• Burger SR, et al. 2003. Cellular engineering of HSV-tk-transduced, expanded T-lymphocytes for GVHD management. Acta Haematologica 110:121-131.
• Burger SR. 2003. GTP/GMP cell engineering for cell and gene therapies. BioProcessing 2:66-69.
• Orchard PJ and McIvor RS. 2003. Gene therapy. In Biologic Therapy of Leukemia, (M. Kalaycio, ed.). Humana Press, Totowa, NJ.
• Orchard PJ, et al. 2003. Human nerve growth factor receptor and cytosine deaminase fusion genes. Human Gene Therapy 14:1009-1016.
• Burger SR. 2003. Issues in implementing gene therapy clinical studies. Cytotherapy (in press).
• Orchard PJ, et al. 2002. Clinical scale selection of anti-CD3/CD28 activated T cells following transduction with a retroviral vector expressing herpes simplex virus thymidine kinase and truncated nerve growth factor receptor. Human Gene Therapy 13:979-88.

QC Testing

Publications:

• Mascotti K and Burger, SR. 2000. Hematopoietic progenitor cell viability measurement: trypan blue versus acridine orange/propidium iodide. Transfusion 40:693-96.
• Burger SR, et al. 1999. Improved progenitor assay standardization using peripheral blood progenitor cells from a donor treated with granulocyte-colony-stimulating factor.
• Transfusion 39:451-56.

Presentations:

• Edward K. 2006. Product Characterization. Miami AABB Annual Meeting
• Burger SR. 2006. Cell Therapy Product Characterization. Technical Session, International Society for Cellular Therapy Annual Meeting
• Burger SR. 2001. Quality for Advanced Cellular Therapies. BioWhittaker Quality Day
• Burger SR. 2000. Product Release Testing In GMP Cellular Engineering. American Association of Blood Banks Annual Meeting