Cell Culture Engineering XIX

Conference Sessions Session 1: New Technologies and Approaches to Enhance Tech Transfer Efficiency and Product Understanding Successful execution of technology transfer and scale-up remain critical capabilities for the cell culture community today. Have our practices evolved to be more efficient in the last few decades? The complexity of manufacturing has increased significantly due, in part, to highly variable product volume demands, network diversity of internal and CMO capacity options, a wide-ranging spectrum of product modalities, the onset of new process technology and formats, and a constant pressure to be faster and more cost-effective. ... Session 2: Innovation in Cell Line Development, from Synthetic Biology to Integrated Process Development This session will focus on the fundamental applications of cell and vector engineering to create recombinant cell lines for biologics and viral vector production with enhanced performance. Topics to be discussed include novel approaches and technologies for host cell engineering, genomic integration and complex vector design, along with innovative methods such as integrating automation, modeling and/or analytics into the clone generation, selection, and screening stages of cell line development. ... Session 3: Systems Biology and Process Modeling for Digitalization of Bioprocessing Systems biology, which includes use of omics technologies integrated with mathematical modeling, provides a systematic way to study and develop strategies to understand, design, optimize and control complex biological systems including cell culture processes. ... Session 4: Product Quality Modulation and Real-Time Controls in Cell Culture Understanding of the relationship between cell culture process control and desirable product quality attributes in protein therapeutics has matured significantly over the past several years. Sophistication in control strategies, analytical outputs and models that link the two has advanced both at the laboratory scale as well as demonstration of implementation and benefit at GMP scale. This session will capture advances in the area of process understanding and process control with the focus on achieving desired product quality attributes. ...