CELL CULTURE ENGINEERING XII (CCE-XII)

Venue: Fairmont Banff Springs Hotel

Location: Banff, Alberta, Canada

Event Date/Time: Apr 25, 2010 End Date/Time: Apr 30, 2010
Abstract Submission Date: Oct 31, 2009
Paper Submission Date: Oct 31, 2009
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Description

Since the 1980s, animal cell culture technology has become essential for the production of an ever increasing number of human and veterinary biopharmaceuticals. These bi-annual Cell Culture Engineering conferences are a leading venue for the academic, industrial and regulatory communities to learn and debate new concepts and issues related to animal cell culture research and development. The 12th in this highly successful series of conferences will be held at the majestic Fairmont Banff Springs Hotel in the heart of Banff National Park, a UNESCO World Heritage Site.

This 2010 meeting will celebrate our conference tradition of high quality and relevance to both industrial and academic participants. We will continue to cover the topics of traditional interest to the community including cell line & cell culture process development, vaccine development, and industrial case studies and challenges. In addition, we will look to the future of our field with special emphasis on emerging technologies that may impact cell culture engineering as well as new opportunities for cell culture engineers thinking beyond the discipline's recent focus on the expression of therapeutic proteins in animal cells.

CONFERENCE ATTENDANCE BY INVITATION ONLY
Attendance will be limited and by invitation only. For effective interactions of all participants, the conference will be limited to about 350 attendees. Invitation will be based on conference participation through chairing a session, poster or oral presentation or other contributions to the conference If you wish an invitation to attend, please complete and return the attached application as soon as possible and no later than November 1, 2009.

ORAL SESSIONS AND SESSION CHAIRS

Current Challenges and Problems:
1) Advances in Cell Culture Process Development. Sherry Gu (Eli Lilly) and Chuck Goochee (Johnson and Johnson)
The purpose of this session is to provide industrial and academic cell culture scientists and engineers the opportunity for a comprehensive presentation describing cell culture process development and scale-up for clinical or commercial manufacturing, providing valuable insights into current challenges and creative solutions. Such presentations may offer an exciting narrative of the technical history of a particular biological product, where cell culture takes a central stage. Alternatively, presentations may be focused more narrowly on relevant sub-topics, including: Process development and intensification; Scale-up and technology transfer; Clinical or commercial manufacturing; Post-licensure process changes.

2) Cellular Effects on Product Characteristics. Ilse Blumentals (GlaxoSmithKline), Mike Butler (University of Manitoba)
Significant progress has been made over the past years in optimizing biopharmaceutical production in cell-culture-based systems. Much of this effort has focused on improving host cell lines, expression systems, and optimization of selection processes to reduce development times and to improve productivity. However, the growing emphasis on understanding the relationship between product characteristics and clinical significance (e.g. biological activity, immunogenicity, pharmacokinetics, etc) has placed a renewed priority on understanding and manipulating cellular mechanisms to control product quality.

This session will focus on the latest advances in understanding how cellular processes impact product characteristics. This will include cell engineering strategies to modulate cellular pathways by genetic manipulation, ‘omic’ approaches to understand cellular mechanisms of product synthesis and secretion, and manipulation of the physicochemical environment of the culture as a means to control the characteristics of the recombinant product. Of particular interest are case studies that demonstrate how the integration of information (genomics, proteomics, cell physiology, and bioprocess data) is used for improved analysis of the biological pathways involved in ensuring consistency of product quality.

3) Challenges in Biotherapeutic Development. Pranhitha Reddy (Amgen), Thomas Ryll (Biogen Idec)
Recognized challenges in recombinant protein therapeutics development include balancing accelerated timelines to the clinic and commercialization with developing high yielding cell lines and processes with desirable product quality. An added challenge is to define and maintain consistent product attributes while optimizing titers and process robustness during late stage development and in preparation for commercialization of the product. Expression yields and product quality of recombinant proteins are influenced by the primary amino acid sequence, the expression system/cell line and the production process.

This session will focus on new enabling technologies that allow for timely prediction and engineering of drug candidates or expression systems to optimize expression and product quality attributes during various stages of drug development (molecule assessment through commercialization). This will include successful application of bioinformatics, biochemical, cell biology and protein engineering methods to predict or improve expression yield, product quality, and new technologies that allow for accelerated time to clinic.

The session will also highlight advances and experimental strategies to define key product quality attributes and application of QbD in early molecule assessment and DOE optimization.

4) Engineering of Cells and Vectors. Mike Betenbaugh (Johns Hopkins University), John Joly (Genentech)
This session will focus on the latest methods to improve production of biopharmaceuticals through reprogramming of host cells or improved vector design. Various mammalian cell hosts used for the production of recombinant proteins, vaccines, and cell therapies will be considered. Examples could include methods to improve vectors to maximize transcription or translation as well as engineering hosts to alter growth, death, metabolism, folding, glycosylation, or development in order to improve product titers and quality.

5) Novel Vaccines & Virology. Amine Kamen (NRC Biotech Research Inst), John Aunins (Merck)
Vectors based on recombinant viruses and viral like particles have shown great promise and play an important role in the development of new vaccines against infectious diseases including pandemics. Oncolytic therapies and cancer vaccines are emerging fields whereas some successes have been reported in clinical evaluation of viral vector-based gene therapies. A key aspect of the success and viability of viral-based applications is the development robust manufacturing strategies. This session thus invites presentation with focus on development strategies for emergent or emergency vaccines; viral vector design and improvement for safety and efficacy; cell line development (e.g., new cells for viral replication); process analytical technologies (e.g., means of assessing viral titers, infectivity, as well as process robustness); process intensification (e.g., strategies for improved viral productivity) and downstream processing of viruses or viral subunits from cell culture contaminants.

Emerging Technologies and Opportunities
6) EMERGING TECHNOLOGIES AND APPLICATIONS. Kris Chan (Michigan State University), Bill Miller (Northwestern University), Ashraf Amanullah (Genentech)
This new meta session will include a variety of presentations on topics related to new technologies that are currently being developed, or that have been employed, to facilitate cell culture engineering. The topics will include omics based technologies that are being used to study molecular changes in gene expression related to favorable phenotypes, high-throughput screening technologies that offer ways to accelerate timelines, single-use technologies that minimize capital cost and issues of cross contamination, new process and product analytical technologies, computational modeling to enhance cell engineering and process development, as well as other technologies. The content of this meta session may span a variety of themes and topics, but all papers will have a common theme of new technologies, or new applications.

7) NEW OPPORTUNITIES FOR CELL CULTURE ENGINEERS. Jamie Piret (University of British Columbia), Matt Croughan (Keck Graduate Institute), Terry Papoutsakis (University of Delaware)
This new meta session will include presentations on a variety of topics intended to address the issue of the future of our field. In particular, the knowledge gained over the past several decades about animal cell platforms and their performance characteristics may start to be applied to other related fields that involve animal cell culture. For example, there are opportunities for cell culture engineers to facilitate the production and implementation of stem cell based therapies as well as in tissue engineering and other areas. This content of this meta session will span a variety of themes and topics that will relate to opportunities for cell culture engineers in the coming years and decades beyond the topics that have been traditionally covered at the CCE meeting.

WORKSHOPS
Organizers: Craig Zupke (Amgen) and Tim Charlebois (Wyeth)

Suggestions for workshop topics are welcome. Planned topics include: Scale Down Models; Scale-up and Tech Transfer Experiences; and others.

POSTER SESSIONS
Overall Chair: Laura Palomares (UNAM, Mexico)

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