Stem Cells and Cell Therapies
There is a growing acknowledgement in the cell culture engineering community regarding the product potential of stem and other cell therapies. The key issues are the control of replication & differentiation and the engineering of cellular systems, especially those of stem cells. Although perhaps the only true stem cells are the embryonic stem (ES) cells, other more accessible stem cells (umbilical cord & adult hematopoietic, neuronal, hepatic, mesenchymal, gastrointenstinal and epidermal) are likely to be of larger clinical interest for cell and gene therapies. The recently discovered plasticity of stem cells (from blood to brain, and from brain to blood, etc, etc, etc), combined with new tools in molecular and cell biology of the genomic and postgenomic era, hold exceptional promise for large advances in both the biology and bioengineering of this exciting field.
Session Chairs:
Madhusudan Peshwa, Dendreon Corporation, (206) 829-1477, mpeshwa@dendreon.com
E. Terry Papoutsakis, Northwestern University, (847)491-7455, e-paps@northwestern.edu

Genomics and Proteomics
The analysis of biological systems is greatly aided by high throughput screening technologies. This session will include presentations on the application of existing technologies and emerging technologies which hold mise for application to the analysis of cell culture processes.
Session Chairs:
Kelvin Lee, Cornell University, 607-255-4215, khlee@cheme.cornell.edu
Wei-Shou Hu, University of Minnesota, 612-626-0587, wshu@cems.umn.edu

Adventitious Agents and TSE's
The session will focus on emerging issues in adventitious agent testing. It will include information on the latest developments on the growth in vitro of transmissible spongiform encephalopathy agents, new testing methodologies for these agents and their implication for cell technology. New virus issues including recent findings on circovirus and bovine polyomavirus contamination of animal supplements will be discussed. These talks will be set in context by a presentation from an industry leader on their experience in controlling adventitious agent contamination.
Session Chairs:
David Onions, The University of Glasgow and Q-One Biotech Inc., 44 141 946 9999, donions@q-one.co.uk
Sally Seaver, Seaver Associates, 978-369-9000, ssseaver@ma.ultranet.com

Cell Physiology and Metabolism
This session will focus on the areas of cell and metabolic engineering, metabolism and physiology of new cell types and cell lines, concepts and systems for regulation of cell proliferation, medium optimization with emphasis on cell mass, productivity, quality and reduction of cell death, and physiological aspects of tissue engineering. New concepts and improvements in physiology and metabolism towards the production of therapeutics will be emphasized.
Session Chairs:
Thomas Ryll, Abgenix, (510) 608-4653, ryll_t@abgenix.com
James Piret,University of British Columbia, (604) 822-5835, jpiret@chml.ubc.ca

Monoclonal Antibody Technologies
This session will focus on technologies and/or strategies for cost-efficient large-scale production of therapeutic monoclonal antibodies. Our intention is to explore recent progress and future potential for improving productivity and cost efficiency of mammalian cell culture systems. Consideration will be given to presentations covering topics such as: approaches to developing and expressing high-affinity antibodies that reduce manufacturing cost per dose, development of high productivity cell culture processes that reduce manufacturing cost per gram, and design / startup of high-capacity cell culture manufacturing facilities. Presentations emphasizing the impact of the work on improving the economics of the antibody or the ability to meet demand for the product would be especially desirable.
Session Chairs:
John Birch, Lonza Biologics, 44 1753 716576, jbirch@lonza.co.uk
Bob Kiss, Genentech, Inc., 650-225-5135, kiss@gene.com

Immortalization, Differentiation, and Cell Death
We now understand a great deal about the regulation of the processes of immortalization, proliferation, differentiation, and apoptosis in a wide variety of different cell types. There is the potential to prevent or delay the aging and death of normal cells, and to direct the production of specific cell types for therapeutic purposes. Genes and proteins involved in these processes also provide targets for new generations of drugs. Talks in this session will focus on the recent advances that have been achieved in understanding and manipulating the mechanisms of aging, differentiation and death. The aim of these talks is to enlighten cell culture technologists and those working in the biopharmaceutical industry of the potential applications in these fields.
Session Chairs:
William Miller, Northwestern University, (847) 491-4828, wmmiller@northwestern.edu
Mohamed Al-Rubeai, University of Birmingham, +44 121 414 3888, m.al-rubeai@bham.ac.uk

Protein Processing, Quality, and Glycosylation
Variations in the analytical characteristics of recombinant proteins is a key area of interest as manufacturing processes are developed or transitioned from scale to scale, between facilities or even between expression platforms. This session will focus broadly on post-translational factors that can influence the quality of recombinant proteins. Discussion will include key cell culture factors affecting overall product quality, strategies for defining appropriate ranges for product quality variations during normal manufacture, and pre- and post-harvest solutions to control product quality within desired ranges.
Session Chairs:
Lynne Krummen, Genentech Inc., (650)225-1997, krummen@gene.COM.
Nigel Jenkins, Eli Lilly & Company, (317)433-3176, njenkins@lilly.com

Viral Vectors for Gene Therapy and other Applications
Important strides continue to be made in the use of viral vectors for gene therapy and vaccination with numerous clinical trials now advancing to pivotal studies. What has emerged from this field is that each vector system possesses its own particular advantages and disadvantages, such that there is no single viral vector that is perfectly suited for all applications. Despite the progress that has been made in the field, significant challenges remain in the areas of vector design, vector production and in obtaining a better understanding of the virus/cell interaction. This session will highlight particular advancements in these areas as well as present exciting new applications of viral vectors for major unmet medical needs.
Session Chairs:
Thomas Wickham, GenVec, Inc., (240) 632 5542, twickham@genvec.com
Weichang Zhou, Merck & Co., Inc., (215) 652 743, weichang_zhou@merck.com

New Developments in Gene Expression
This session will focus on methodologies to enhance transient or stable protein expression through cell line engineering. The development of new vectors, the manipulation of integration events, the importance of chromosomal architecture and its relation to gene expression, and high throughput methods will be discussed.
Session Chairs:
Gene Schaefer, Schering-Plough Research Institute, (908) 820-6138, eugene.schaefer@spcorp.com
Tom Kost, GlaxoSmithKline, (919) 483-3218, tak4306@gsk.com

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