August 19-20, 2013
Cambridge Healthtech Institute’s 9th Annual
Optimizing Cell Culture Technology
Enhancing Knowledge for Growing Cells
Day 1 | Day 2 | Short Courses | Download Brochure
Monday, August 19
1:00 pm Chairperson’s Opening
Remarks
1:10 Opening Keynote
Presentation:
Optimizing Cell Culture
Production Processes – Trends, Challenges and Opportunities
Thomas Ryll, Ph.D., Director, Cell
Culture Development, Biogen Idec, Inc.
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 Shimoni, Ph.D., Principal
Engineer, Manufacturing Sciences, Bayer HealthCare LLC
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
2:45 Refreshment Break
3:15 Top-Down versus Bottom-Up
Design of Mammalian Cell Culture Media: Advantages and Disadvantages
Patrick Hossler, Ph.D., Senior
Scientist III, Process Sciences, AbbVie Bioresearch Center
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 Goetschalckx, Manufacturing
Cell Culture Science Lead, Technology Division, Genzyme
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.
5:15 Discussion Report-Outs
5:30 Grand Opening Reception in the
Exhibit Hall with Poster Viewing
7:00 Close of Day
Day 1 | Day 2 | Short Courses | Download Brochure