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Optimizing Cell Culture Technology - Day 1


Optimizing Cell Culture Technology 

This meeting will explore today's evolving strategies and technologies for improving the robustness of mammalian cell cultivation. From media enhancement to providing the optimal culture conditions, this leading cell culture meeting is designed to provide helpful information to optimize the job of growing mammalian cells, including a session specially focused on CHO (Chinese Hamster Ovary cells).

Optimizing Cell Culture Technology will include talks from industry experts that address critical issues in an atmosphere that encourages sharing, learning, and networking. The agenda will again feature small-group breakout discussions that provide the opportunity to discuss important topics with your peers in a fun and collegial setting. In addition, case studies will be presented that shed light on improving yield while maintaining product quality.

Day 1 | Day 2 | Download Brochure 

Monday, August 22

11:30 am Main Conference Registration

 

OPTIMIZING INSIGHTS TO ENHANCE CELL CULTURE PROCESSES 

1:00 pm Chairperson's Opening Remarks

Sheila G. Magil, Ph.D., Senior Consultant, BioProcess Technology Consultants, Inc.

1:10 OPENING KEYNOTE PRESENTATION
High-Throughput Cell Culture Technologies: Challenges and Future Trends

Jianguo YangJianguo Yang, Ph.D., Principal Scientist, Commercial Cell Culture Development, Commercial Process Development, Biologic R&D, Genzyme - Biography 

Demand for high-throughput (HT) cell culture technologies has increased dramatically in the biopharmaceutical industry because the technologies are  of  vital importance  to cell culture process  optimization,  media development, and most recently in the Quality by Design (QbD) approaches expected by regulatory agencies.  Although HT cell culture technologies have advanced quickly from half-liter to micro-liter scale, there are some major challenges remaining, especially in mammalian cell line and cell culture development, and a true high-throughput cell culture process is yet to come. This presentation will articulate current advances, major challenges and future trends in HT cell culture technologies.

1:45 FEATURED PRESENTATION
Metabolite Profiling of Recombinant Mammalian Cell Lines: Putting the Data to Work

Alan Dickson, Ph.D., Professor, Biotechnology, and Director, Centre of Excellence in Biopharmaceuticals, Faculty of Life Sciences, The University of Manchester - Biography 

This presentation will focus on metabolite profiling (extra- and intra-cellular) of recombinant mammalian cell lines. In our experience, metabolite profiling is an 'omics approach that offers immediate insights for understanding key processes that determine product yield. I will describe our approach for metabolite harvest and assessment (with a focus on the critical need for generation of physiological concentrations of intracellular metabolites) from cells in suspension culture and illustrate, with case studies, how this approach can lead to enhanced culture performance.

2:15 Approach and Challenges to Developing a Platform Cell Culture Process

Wendy Hsu, Engineer and Group Leader, Early Stage Cell Culture, Genentech, Inc.

Speed to tox and Phase I material production is often key in establishing the competitive advantage for a product. This presentation summarizes Genentech's approach in establishing a platform cell culture process using a new chemically defined media that enables meeting development timelines to tox and PhI material production while establishing basis for late stage development. The presentation highlights challenges to the platform process development from implementation of a new media. The presentation also highlights challenges to the platform process development in accommodating a wide range of culture phenotypes such as high growth and high oxygen uptake rate.

2:45 Networking Refreshment Break

3:15 POSTER HIGHLIGHT:  Optimization and Modification of Glycosylation Profiles of a Monoclonal Antibody During Mammalian Cell Culture Process Development

Sarath Moses, Ph.D., Senior Scientist, Bioprocess Development, Merck Research Laboratories

3:45 Cost-Efficient and Consistent Single-Batch Manufacturing of Antibody Mixtures

Søren Kofoed Rasmussen, Ph.D., Principal Scientist, Symphogen A/S

Development of combination products consisting for example of two or more antibodies with synergistic properties for treatment of serious human disease is becoming increasingly important. Symphogen has developed a manufacturing platform, Sympress, which allows fast, reproducible and cost-efficient development of antibody mixtures for human therapy of complex diseases like cancer and infections. In 2010, Symphogen started clinical trials with one such product, a combination of two antibodies against the EGFR which has shown clear synergistic properties. The single-batch manufacturing technology comprised in Sympress provides a very attractive solution - with respect to cost, timelines and batch-to-batch consistency - to the CMC challenges linked to development of these types of APIs.

4:15 Moderated Small-Group Breakout Discussions 

Discussion groups give participants an opportunity to network and discuss important topics with colleagues from around the world.  We set aside this time for conference attendees to interact around a focused discussion topic, get to know one another, and develop contacts.  Meeting delegates select what discussion they would like to join from the list of topics provided, and the talk begins. The discussions are engaging, and a great way to network, exchange information, and establish future collaborations.

Please select from the tables below:

1. Downsizing Protein Production: Microscale Approaches to Early-Stage Protein Expression Screening 

Moderator: Dominic Esposito, Ph.D., Principal Scientist, Protein Expression Laboratory, SAIC-Frederick, Inc.

Many labs are interested in optimizing expression of proteins for improved yield, activity, or stability.  A great deal of time and effort can be expended in troubleshooting and optimization of the various components of protein production at scale, which reduces efficiency and often leads to a reduction in the number of variables tested for a given protein.  New techniques have been developed to reduce the scale at which the various stages of the process occur, and permit a larger number of variables to be looked at in initial microscale screening.  We will discuss some of these options and the experiences that people have had with them.

• Microscale purification technologies
• Small-scale expression in bacteria, insect cells, and mammalian cells
• High-throughput parallel cloning for expression vector construction
• Scale-up optimization

2. Best Practice vs. Standard Practice in Cryopreservation

Moderator: John Baust, Ph.D., UNESCO Professor & Director, Institute of Biomedical Technology, Binghamton University

• How helpful are published "Best Practices?"
• How are these Best Practices individualized to local "Standard Practices?"
• What additions should be made to published Best Practices?

3. Is Lactate Still an Issue in Your Cell Culture?

Moderator: Matthew Gagnon, Scientist, Culture Process Development, BioProcess Research and Development, Pfizer, Inc.

• How is/was lactate a problem (e.g., scale-up issue, clone issue)?
• What methods are/were used to address the problem (e.g., perfusion, media development, glucose limitation, cell line engineering)?

4. Integration of Complex 'Omics' Datasets: Generation of Meaningful Output

Moderator: Alan Dickson, Ph.D., Professor, Biotechnology, and Director, Centre of Excellence in Biopharmaceuticals, Faculty of Life Sciences, The University of Manchester

'Omics technologies offer great potential for development and rationalisation of bioprocessing - from design of expression platforms and cell line development through to coupled downstream processes for effective product recovery and stability. The detailed mass of information from 'omics' studies are accumulating but the challenge that faces us is how this mass of data can be used by non-expert, informed practitioners in an integrated manner to identify and apply approaches to enhance bioprocessing. Our discussions will focus on this challenge.

• Nature of datasets and their availability
• Approaches to integrate data - experience from other systems
• Successful exemplars of use of single or multiple datasets
• Skill-sets needed (expected) for interpretation
• Future needs for the sector

5. Native or Tagged--Getting a Handle on Proteins

Moderator: Geoffrey S. Waldo, Ph.D., Team Leader, Biosciences, Los Alamos National Laboratory

• When do you do native purifications and when do you use tags?
• What do you use you tags for?
• How do you get your tags off?
• What are the pros and cons of tags?

6. Which Tagging Strategies Work?

Moderator: Paul Ramage, Ph.D., CPC, Protease Platform, Senior Research Investigator, Novartis Pharma AG

 

7. Self-Cleaving Tag Developments and Issues

Moderator: David Wood, Ph.D., Associate Professor, Chemical & Biomolecular Engineering, Ohio State University

8.  Analytical Requirements Throughout Development, What are the Real Needs?

Moderator: Sheila G. Magil, Ph.D. Senior Consultant, BioProcess Technology Consultants

Many early stage biopharmaceutical companies struggle with the requirements for analytical validation – especially when is it required and for which analytical methods. This is especially confusing when process development is outsourced to CMOs which have their own "way of doing things." We will discuss how to approach balancing the needs of early stage development and analytical resources to regulatory expectations. Some of the areas we will discuss include:

• Which analytical methods and when
• Managing CMOs to get "on board" with reduced requirements
• Phasing in analytical methods

5:30 Grand Opening Reception with Exhibit & Poster Viewing

7:00 End of Day One



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