CONFERENCE AGENDA

• An overview of glycosylation methods
• Mechanisms by which media design evolve glycosylation patterns
• Benefits of glycosylation by media design

• Using cell engineering to replace animal-derived therapeutics
• Metabolic engineering of CHO cells-a new paradigm in bioprocessing
• The role of bioprocessing in controlling productivity and product quality for novel biopharmaceuticals

• Development of a robust and reliable self-cleaving tag capture resin
• Case studies and results for recent biosimilars
• Comparisons to Protein A from a regulatory and process impact standpoint

• Replace resistance genes with non-coding RNAs and transfected mRNA for selection
• Increased titers by eliminating translational overhead of resistance genes
• Selection processes include: magnetic isolation and depletion, FACs and death

• We have studied the molecular response of CHO cells to several viruses that have shut down production of biotherapeutics in various companies
• We demonstrate that CHO cells can be more resistant to infection using a few different bioprocess treatments
• A deep analysis of the infection and treatments highlights opportunities to engineer virus resistant cells

• Differentiation of iPS-derived Endothelial Cells in vitro using 3D culture system.
• Characterisation of in vitro generated cells using Next Generation Sequencing.  
• Developing novel hybrid materials and 3D bioprinting technology that can control endothelial cell function in pre-vascularised muscle constructs.

• Teresa Safly, Area Business Manager, Beckton Dickinson
• ​Jennifer Gelman, Marketing Communication Manager, BD

Roundtable 2: Post translational regulation-The use of mRNA and Non Coding-RNA for cell line selection

• Ted Eveleth,CEO, HocusLocus

Roundtable 3: Holistic statistical tools-  advancing biomanufacturing.

• Martin Kane, Former Director of Process Statistics, GlaxoSmithKline

Roundtable 4: Continuous process- High density cell culture technologies and challenges

• Winnie Yeung, Senior Research Associate II, Biologics Development- Cell Culture, Gilead Sciences

• Developing project strategy and goals to facilitate collaboration
• Examples of cross-functional data sharing to drive optimal process choice
• Using DoE studies to build database to inform future process development

• Process strategies to overcome the limitations of conventional batch cultivations
• GMP compliant cultivation platforms
• Developing continuous systems to increase the efficiency of production

• Taking advantage of real-time monitoring to learn more about your process and detect changes
• Building methods to monitor nutrients and metabolites in bioprocessing
• Utilizing Raman in a perfusion system to closely monitor dynamic changes in cell growth and nutrient consumption

• Statistical methods and multivariate decision tools
• Machine learning and hybrid models
• Process control using online monitoring and supervisory control
• Quality prediction

• DCO₂ is a critical parameter from a quality and performance perspective, impacting productivity, growth rates, and product quality.
• DCO₂ concentration directly impacts key metabolic pathways and intracellular and extracellular pH
• Inline DCO₂ measurement can be critical for process control and optimization, scale-up and scale-down models, and process understanding

• Complete knockout of lactate dehydrogenase
• Drastic decrease in required base addition for pH stability in culture
• Knockout cells exhibit prolonged growth in fed-batch culture

• Single-use technologies (SUTs) are being rapidly adopted by the biopharmaceutical industry.
• Overview of single-use technology - where and why SUT is used.
• Challenges for implementation of single use for cell culture operations at commercial scale - what are the gaps?