SC1: OPTIMIZING CELL CULTURE MEDIA
MONDAY, AUGUST 12 | 8:30 – 11:00 AM
Detailed Agenda
Waterfront 1C
8:30 Common Strategies for the Development of Serum-Free Media Formulations for High Productivity in Mammalian Cells
Michael Butler, PhD, CSO, Cell Technology, National Institute for Bioprocessing Research and Training (NIBRT)
• Serum-free media is usually constructed from 60-70 components designed to substitute for serum
• Reductive and synthetic approaches may be used to design formulations
• Optimal concentration of each component is required to maintain high productivity
• Unstable components should be identified and replaced
• Definitive Screening Design is a good design of experiment (DOE) to optimize formulations
9:10 BioProcess Optimizer: A New Technology to Optimize Biologics Production and Cell Therapy Cultures
Ana Luz Quiroga Campano, PhD, Postdoctoral Fellow, The Wallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology
We have developed a new culture media technology to optimize productivity of cultures for biologics and cell therapy. The computational tool is based on an experimentally validated mathematical model that optimizes simultaneously two culture conditions: medium composition and feeding strategy. The framework has three stages: i) batch experiment: culture analysis, collection of specific clone behavior information and calculation of critical parameters to capture cellular response to nutrient concentrations; ii) fed-batch non-optimized: Model-based medium design and feeding strategy for a non-optimized fed-batch culture, the data from which is used to determine clone behavior under fed-batch conditions iii) Optimized fed-batch culture: the optimized medium composition and feeding strategy simplifies nutrient concentrations control, keeping all nutrients available in a tight concentration range. The result is a fed-batch culture that operates in steady-state for a longer period, minimizing raw materials use, eliminating overfeeding (waste) and underfeeding (starvation), reducing equipment size, increasing viability, extending culture longevity and increasing productivity (in total by 128%).
9:45 Refreshment Break
10:15 Media Development for Intensification of Seed Train Expansion including N-1 Perfusion
Jana Mahadevan, PhD, Senior Scientist, Cell culture Perfusion Media & Bioprocess Development, MilliporeSigma, Merck KGaA
Seed train expansion as well as the media composition used during the cell culture steps play a critical role for biopharmaceutical production. We could show that the right combination of media, specially designed for their purposes, in a seed train including a perfused N-1 step can increase productivity in the final production step. This indicates that the specific companion media combinations can increase productivity for intensified process formats.
11:00 End of Short Course
Instructor Biographies
Michael Butler, PhD, CSO, Cell Technology, National Institute for Bioprocessing Research and Training (NIBRT)
Michael Butler is the Chief Scientific Officer at the National Institute of Bioprocessing Research & Training (NIBRT), Ireland, Adjunct Full Professor in University College Dublin as well as Distinguished Professor Emeritus of the University of Manitoba, Canada. He holds degrees in Chemistry and Biochemistry from the Universities of Birmingham, London (UK) and Waterloo (Canada). He was the scientific director of MabNet, a Canadian network for Mab production and founder of Biogro Technologies Inc., a spin-off company dedicated to serum-free media development. His research work focuses on the development of bioprocesses using mammalian cells for the production of recombinant proteins, monoclonal antibodies and viral vaccines.
Ana Luz Quiroga Campano, PhD, Postdoctoral Fellow, The Wallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology
Ana Quiroga received her PhD (2017) in Chemical Engineering from Imperial College London, and her MSc in Chemical Engineering and Double major BSc (Eng) in Chemical Engineering and Bioengineering from Universidad de Chile. She is an innovative bioengineer and researcher interested in metabolic engineering, product quality and process development; mathematical modelling, optimization and control of biopharmaceutical processes and cell therapies; and pharmacokinetic and pharmacodynamic models. Her expertise is in mathematical modelling of biological systems and cell cultures, focused on model-based optimization of enzymes production in bacteria, monoclonal antibodies in mammalian cells and leukemia treatment using combination of chemotherapy/immunotherapy drugs. Ana is a Postdoctoral Fellow in the Department of Biomedical Engineering at Georgia Institute of Technology.
Jana Mahadevan, PhD, Senior Scientist, Cell culture Perfusion Media & Bioprocess Development, MilliporeSigma, Merck KGaA
Jana Mahadevan received her PhD in Biochemistry from University of Madras, India, provided molecular insights for the demise of human lymphocytes by the commercially available drug that has been in use for the treatment of type 2 diabetes. This was followed by 6 years of post-doctoral fellowship in Pacific Northwest Diabetes Research Institute, Seattle in the field of islet biology and identified a drug which is currently in clinical trials for hearing loss, that preserve beta cells mass in rodent model of type 2 diabetes. She then moved to Washington University School of Medicine, Saint Louis and further expanded her knowledge not only in diabetes but also understanding the neurodegenerative endoplasmic reticulum-related rare diseases, Wolfram syndrome. She discovered a soluble endoplasmic reticulum factor based regenerative therapy for diabetes & neurodegeneration in Wolfram syndrome. She has diverse background in nutrient-metal toxicity, cellular redox, cell & amino acid metabolism, antioxidant & signal transduction pathways. She is currently working for MilliporeSigma as a Senior scientist, in an innovation team of upstream bioprocess development working in cell culture media development for perfusion, bioprocess optimization and improving culture strategies to enable high cell density suspension cultures for intensified/continuous process applications. Addition to that, she is actively working on various tools & technology evaluation for product/process development and innovative upstream technologies.