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Tuesday, September 26 - Day
One
12:00 - 1:45 Registration
Optimizing
Processes
1:45 - 2:00 Chairperson’s Remarks
Professor Dr. Ralf Wagner, Chief Executive Officer and
CSO, GENEART AG
2:00 - 2:30 Systematic and Logical
Strategies to Support Process and Product Development Optimization
Tsu-shun Lee, Ph.D., Deputy Director Principal Scientist US, Manufacturing Technology, sanofi pasteur
Due to
the need for parallel development of multiple projects, the
production of a new biopharmaceutical candidate requires efficient
use of resources and extensive process optimization and
characterization in order to ensure a robust manufacturing
process. The numerous complex variables to be studied, along with
their interaction in the process development stage, can be
especially tedious and time consuming to pursue. As a result, it
becomes an important issue for Process Development Groups to
develop efficient ways to generate high quality data in a
shortened time frame. This presentation will focus on a strategy
that Process Development Groups can utilize to overcome process
development, scale-up, technology transfer, validation, and
manufacturing process improvement challenges.
2:30 - 3:00 Development, Optimization, and
Scale Up of Plant Cell Fermentation Processes: Significance,
Challenges, and Impact
Sarad Parekh, Ph.D., Director,
Cell Culture Process Development, Phyton Biotech, Inc.
Process development for the commercial production of
biopharmaceuticals using Phyton’s plant cell culture technology
requires expertise in multiple areas. This presentation will
review Phyton’s overall approach to process development, from
strain development and optimization of upstream process parameters
to pilot level scale up. The importance of strain selection and
upstream process characteristics for productivity enhancement and
product quality and reproducibility will be discussed. In
addition, Phyton’s approach to the certification of reliable
growth and productivity
features for production strain banks will be a subject of the
presentation.
3:00 - 3:30 Top-Down and
Bottom-Up Characterization of Glycoproteins: A Synergy of New and
Traditional Methods
Thomas J.
Porter, Ph.D., Associate Director, Characterization and Analytical
Development, Wyeth Biopharma
Rapid analysis of intact glycoproteins by liquid
chromatography/mass spectrometry permits a global view of a
protein’s heterogeneity, including glycoform distribution and
other, low-level modifications. Integration of this
"top-down" approach with traditional peptide mapping and
glycan fingerprinting coupled to mass spectrometry is the
foundation of a powerful and comprehensive
"top-down/bottom-up" characterization strategy. Several
examples of the application of this strategy to glycoprotein
therapeutics in various stages of development will be discussed.
4:05 - 4:35 The Effect of Introns on Monoclonal Antibody Expression and Product
Quality in Chinese Hamster Ovary DG44
Cells
Lin Zhang, Ph.D., Senior Principal Scientist, Worldwide Pharmaceutical Sciences, Pfizer
Inc
Dihydrofolate reductase (dhfr)-deficient Chinese Hamster Ovary (CHO) cells (CHO-DG44) are widely used by the biopharmaceutical industry for commercial monoclonal antibody (mAb) production. Cell lines with higher titers are needed to efficiently utilize available production capacity and to lower the cost of goods. A multitude of factors can affect the heterologous gene expression level in mammalian cell lines. Introns can affect expression by influencing transcription, polyadenylation, mRNA processing, and mRNA stability. In our first study, we examined the effect of introns on the titer of two monoclonal antibodies in CHO-DG44 cells. These mAbs with introns in the coding sequence demonstrated a significant improvement in expression when compared to controls. In a second study with a third mAb, a heavy chain species was identified with a higher than normal molecular weight. This species was present as at a low percentage of the total heavy chain protein. Biochemical analysis showed that this species contained an additional 50 amino acid sequence that originated from the translation of an intron. Introduction of an in-frame stop codon at the 5’ - end of the intron completely removed the modified heavy chain as determined by RT-PCR analysis of the transfected cells and by SDS-PAGE analysis of purified monoclonal
antibody.
4:35 - 5:30 Moderated Roundtable
Discussions
To suggest a topic or nominate a
moderator, contact Mary Ruberry at mruberry@healthtech.com
5:30 - 5:45 Roundtable Report Out
5:45 - 6:45 Reception in the Exhibit Hall
6:45 End of Day One
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