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2013 Archived Content

August 19-20, 2013

Cambridge Healthtech Institute’s 9th Annual
Optimizing Cell Culture Technology

Enhancing Knowledge for Growing Cells


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Monday, August 19


Optimizing Cell Culture Processes 

1:00pm  Chairperson’s Opening Remarks

Alan Dickson, Ph.D., Director, Centre of Excellence in Biopharmaceuticals (COEBP); Professor, Institute of Biotechnology, University of Manchester - Biography 

 

1:10 Opening Keynote Presentation:

Optimizing Cell Culture Production Processes – Trends, Challenges and Opportunities

Thomas-RyllThomas Ryll, Ph.D., Director, Cell Culture Development, Biogen Idec, Inc. - Biography 

Today many of the fundamental challenges of cell culture technology have been solved and industry leaders have developed platform process formats that deliver high productivity and product titers in the 5 g/L range consistently for antibodies. However, significant challenges and opportunities still exist and demand attention in order to further improve speed to clinic, process consistency and product quality control for example. The presentation will highlight challenges and opportunities in these fields and use case studies to elucidate trends and potential solutions.

1:45 Increasing Production Capacity of a Legacy Product through Process Improvements

Yuval-ShimoniYuval Shimoni, Ph.D., Principal Engineer, Manufacturing Sciences, Bayer HealthCare LLC - Biography 

The implementation of post-licensure process improvements in the biopharmaceutical industry can benefit patients and drug manufacturers alike. This talk will demonstrate how an identified change (e.g., to the cell culture medium/process) can be successfully taken from proof-of-concept, through scale-up, to demonstration of feasibility; it will further illustrate the scope and complexity of implementing the change in commercial manufacturing in order to realize significant benefits, such as increased production capacity compared with the current legacy process.

2:15 Automated Assessment of Cell Aggregation in Culture

Agata Villiger-Oberbek, Ph.D., Process Associate Scientist, Commercial Cell Culture Development, Genzyme Corporation, a Sanofi Company 

Cell aggregation is a major issue during process scale-up and commercial manufacturing. Using a high throughput model, we evaluated the performance of CHO cultures supplemented with an anti-clumping agent at different concentrations. To support this effort, we developed an ImageJ macro to determine the extent of cell aggregation. This tool has allowed a rapid and unbiased processing of large numbers of cell culture images, saving time and effort in our goal to assess the properties of the anti-clumping agent.

2:45 Refreshment Break

3:15 Top-Down versus Bottom-Up Design of Mammalian Cell Culture Media: Advantages and Disadvantages

Patrick-HosslerPatrick Hossler, Ph.D., Senior Scientist III, Process Sciences, AbbVie Bioresearch Center - Biography 

Two approaches were pursued for the refinement of our platform chemically-defined feed media. A top-down level approach utilized a novel media enrichment strategy. A bottom-up level approach utilized robotic liquid handling and high-throughput screening of media variants. Both approaches increased antibody titers in CHO cell lines at g/L levels. Product quality was not adversely affected, and in fact, it was found that select product quality attributes could be both fine-tuned and controlled. The advantages/disadvantages of these approaches will be discussed.

3:45 Challenges of Raw Materials in Mammalian Cell Cultures: A Case Study

Sofie GoetschalckxSofie Goetschalckx, Manufacturing Cell Culture Science Lead, Technology Division, Genzyme  - Biography 

The effect to implement new/replace existing raw material on the cell growth, productivity and product quality cannot be predicted and therefore, comprehensive assessments and small scale studies are required to evaluate the impact on new and established legacy processes. Throughout the case studies, approach and results will be presented in order to address potential risk, impact and remediation plans. Furthermore control strategy and additional areas of improvement in the management of risks will be discussed.

4:15 Small-Group Breakout Discussions

This session provides the opportunity to discuss a focused topic with peers from around the world in an open, collegial setting. Select from the list of topics available and join the moderated discussion to share ideas, gain insights, establish collaborations or commiserate about persistent challenges. Then continue the discussion as you head into the lively exhibit hall for information about the latest technologies.

1.  Clonal-Derived Cell Lines
Moderator:  Alan Dickson, Ph.D., Director, Centre of Excellence in Biopharmaceuticals (COEBP); Professor, Institute of Biotechnology, University of Manchester
    • What is a clone and proof of clonality
    • Regulator pressures for clonal-derived assurance
    • Relationship to acceptable product quality attributes
    • Polyclonal- and transient-derived products - therapeutic potential?

2.  How to Further Improve Volumetric Productivity in High-Producing Recombinant Cells
Moderator:  Zhimei Du, Ph.D., Senior Scientist, Amgen 

3.  Single-Use Technology (SUT) for Scaling Up Adherent Cultures
Moderator:  Kate Strathearn, Ph.D., Cell Applications Scientist, Corning Life Sciences
    • What current methods are being explored?
    • What, if any, problems are people encountering with SUT?
    • Are current technologies fulfilling production demand?
    • How do microcarriers factor into your process development and beyond?
    • What is the future of SUT for scaling up cells?
 

4.  The Pros and Cons of 2D and 3D Cell Cultures for Bioprocessing 
Moderator:  Mark DeCoster, Ph.D., Associate Professor, Biomedical Engineering, Louisiana Tech University    • Why will we keep 2D cell culture?
    • What are the challenges of 3D cell culture?
    • Micro and nano materials processing in 2D/3D cell culture

5.  Topic: TBAModerator:  Lada Laenen, Ph.D., Managing Principal Scientist, Head, Cell Culture and Microbiology, Technology Division, Genzyme, a Sanofi Company 

6.  The Future of CHO Cell CultureModerator:  Charles Golightly, Ph.D., Bioreactor Product Development, Pall Corporation 

    • Industrial use
    • Productivity
    • Continuing challenges

7.  Controlling Raw Materials in Cell CultureModerator: TBA  

    • Media
    • Cell Lines
    • Replacing raw materials in processes
    • Analyzing quality

5:15 Discussion Report-Outs

5:30 Grand Opening Reception in the Exhibit Hall with Poster Viewing

7:00 Close of Day



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