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MONDAY, AUGUST 20

This leading cell culture meeting will explore today’s evolving strategies and technologies for improving the robustness of mammalian cell cultivation.

As bench scientists strive to reach ever higher titers, the omic sciences, such as metabolomics and genomics, open up emerging pathways for improving cell culture, as do performance excellence approaches (QbD, PAT, DoE). Along with discussing these breakthrough technologies, experts will also shed light on optimizing conditions as well as cell biology to help achieve demanding goals more often and more consistently.

In addition to case studies that highlight yield improvement, experts will also address where cell culture is heading in order to meet ever greater production demands while maintaining product quality.

Optimizing Cell Culture Technology is designed to provide helpful information to optimize the job of growing cells 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 an enjoyable, collegial setting.

8:00 am Pre-Conference Registration and Morning Coffee

11:30 am - 5:30 pm Main Conference Registration

OPTIMIZING CELL CULTURE PROCESSES 

1:00 Chairperson’s Opening Remarks

» 1:10 OPENING KEYNOTE PRESENTATION: 

Implementation of Risk Mitigation Strategies for Upstream Operations

Ayda Mayer, Ph.D., Director, Process Development, Human Genome Sciences, Inc. - Biography 

Case studies on implementing risk mitigation strategies and methods to achieve operational excellence in manufacturing will be presented. These initiatives are critical to continuously produce safe and quality products, further understand and improve the production process, and enhance the robustness of the product supply chain. 

» 1:45 FEATURED PRESENTATION: 

Technology for Accelerating Cell Line Selection and Increasing Fed-Batch Production

James M. Piret, Ph.D., Professor, Chemical & Biological Engineering, Genome Science and Technology, University of British Columbia

Production cell line selection is typically the longest step in the development of new mammmalian cell manufacturing processes. To accelerate this step, we have developed a microfluidic platform for the clonal culture and the antibody productivity assessment of suspension-adapted mammalian cells. The robustness, flexibility and scalability of this microfluidic platform provide unique advantages for the rapid generation of clonal cell lines. 

2:15 The Challenges Associated with Establishing Product Quality Comparability while Making Process Modifications

Natarajan Vijayasankaran, Ph.D., Engineer II, Late Stage Cell Culture, Genentech, Inc. - Biography

This presentation will focus on a case study of the development of a chemically defined cell culture process for production of a monoclonal antibody that is in later stages of clinical development. The challenges associated with matching product quality attributes to protein synthesized from an earlier version of the process will be discussed. Process and culture medium modifications combined with mathematical modeling approaches, when appropriate, used to establish product quality comparability.

2:45 Sponsored Presentation (Opportunity Available)

3:00 Refreshment Break

OPTIMIZING UPSTREAM PROCESSING 

3:15 Tackling the Challenges of Designing a Platform USP for the Next Generation Bispecific Antibody Format, the Kappa/Lambda-Body

Laura Di Grazia, M.S., Head, Upstream Processing, Manufacturing, NovImmune SA - Biography

Novimmune has recently developed a novel therapeutic bispecific antibody format, the Kappa/Lambda-body, which displays the innovative particularity of presenting two different light chains (one Kappa and one Lambda), with a common heavy chain: thus, generating a unique fully human bispecific product that is indistinguishable from a standard IgG. The talk will address the manufacturability of this format using a chemically defined, animal component free process, by demonstrating the successful expression of Kappa/Lambda-bodies in semi-stable CHO pools and stable CHO cell lines, both in shake flask and bioreactor models. Cell line screening approaches for selecting high bispecific Ab-producing cell lines were optimized and challenges were overcome using innovative analytical techniques to distinguish the bispecific from the monospecific format, based either on differential antibody charge/hydrophobicity or using a specific ELISA format. The impact of cell line Kappa/Lambda chain ratio on downstream processing will also be discussed. Overall, cell cultures presented comparable total mAb productivities and growth characteristics to those expressing the corresponding kappa or lambda monospecific antibodies.

3:45 Effect of Raw Materials and Processing Technologies of Dry Powder Media on Titer and Beyond

Jörg von Hagen, Ph.D., Head, Process Development, Merck KGaA - Biography

In the area of mammalian cell culture, media solubility, homogeneity, batch-to-batch consistency, and other classical physico-chemical properties are fundamentals. In different cases, the effect of solubility and the processing of critical ingredients will be presented. Moreover, the presentation will capture the bridging impact of raw material selection and treatment on the critical quality attributes of new biological entities. As platform media and feed are established in the biopharmaceutical industry, there is a need for media suppliers to allow for high-concentrated liquids converted from dry powder. These aspects are addressed and important steps to achieve high-concentrated soluble feeds are presented.

5:15 Breakout Group Summaries

5:30 Welcome Reception in the Exhibit Hall with Poster Viewing

7:00 End of Day

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