Monday, August 15
SC1: OPTIMIZING MEDIA FOR CULTURING CELLS

AGENDA

9:00 Media-Based Strategies to Improve Process Robustness and Influence Process Performance

Sara Gall, M.S., Senior Engineer, Process Development, Drug Substance Technology & Engineering, Amgen, Inc.

This case study will describe the application of targeted media changes to influence and control mammalian cell culture performance. Specific strategies used in this case study included replacing soy hydrolysate with chemically-defined components, substituting heat-labile components with stable chemical equivalents, modulating the relationship between sodium bicarbonate and carbon dioxide, and media segmentation to allow high temperature/short time treatment. These changes reduced process variability and influenced key product quality attributes.

9:30 Recent Advances in Cell Culture Media Design and Optimizations for Production of Biologics -- Case Study

Kamal A. Rashid, Ph.D., Director & Research Professor, Biomanufacturing Education & Training Center, Biology/Biotechnology, Worcester Polytechnic Institute

Media composition plays a significant role in cell yield and viability in the culture. Yield and viability are very important factors in productivity of cell-based processes for biologics production. Animal cell culture media contains a mixture of amino acid, vitamins, glucose, salts and other nutrients such as growth hormones and growth factors. The requirements for these nutrients vary from one cell line to another making optimization studies an absolute necessity for individual cell lines. This presentation will highlight the importance of media components and some recent efforts to optimize nutrients for large-scale recombinant protein production.

10:00 Refreshment Break

10:30 Modeling the Behavior of Amino Acids in Multi-Component Aqueous Solutions Including Cell Culture Media – New, Unpublished Data

Andrew Salazar, M.Sc., Scientist, Biomaterial and Technology, Merck Lifescience

Amino acids are a diverse set of molecules with varied structural and physico-chemical properties. Concentrations of these molecules and their behavior in solution need to be considered since they are basic units of proteins and occupy central metabolic roles. Using statistical thermodynamics and molecular dynamics, the properties, of multi-component solutions can be modeled and better understood. This lays the foundation of in silico formulation of cell culture media.

11:00 Morphology and Compositional Analysis of Chemically Defined Media – New, Unpublished Data

Catherine Lynes, M.Eng., Associate Scientist II, Cell Culture Development, Technical Development, Biogen

A novel analytical method was developed to analyze chemically defined media at the particulate level. Characterization of chemical composition and morphology provide insight into impurities and variations between lots and suppliers which may affect cell growth rates and media dissolution properties. Autonomous data acquisition and analysis afforded detection of multiple components in a short period of time; thus, this method can augment traditional chromatographic techniques.

11:30 End of “Optimizing Media” Short Course

 

INSTRUCTOR BIOGRAPHIES:

Sara_GallSara Gall, M.S., Senior Engineer, Process Development, Drug Substance Technology & Engineering, Amgen, Inc.

Sara Gall is currently a senior engineer in Amgen Cambridge's drug substance technology and engineering department. She has worked at Amgen, primarily in Colorado, for ten years. She spent the first 9 years of her career in late stage cell culture process development. She has served as the cell culture lead on 5 different molecule projects and as the process lead for a biosimilar molecule. Sara received her bachelor's of science in chemical engineering from Colorado State University in 2001. She received her master's of science in chemical engineering from the University of Colorado in 2003.

Catherine_LynesCatherine Lynes, M.Eng., Associate Scientist II, Cell Culture Development, Technical Development, Biogen

Catherine is a scientist in the Cell Culture Development division at Biogen. Since joining Biogen in 2015, her work has focused on implementing an extensive and holistic analytical approach to characterize raw materials within biopharmaceutical cell culture production. Her group combines spectroscopic, chromatographic, and microscopic techniques with data reduction and chemometrics methods to detect and analyze variations within raw materials. Catherine holds a BS in Chemistry from Stonehill College and a Masters of Engineering in Chemical Engineering from Cornell University.

 Kamal_RashidKamal A. Rashid, Ph.D., Director & Research Professor, Biomanufacturing Education & Training Center, Biology/Biotechnology, Worcester Polytechnic Institute
Dr. Kamal A. Rashid has over thirty five years of academic experience in both research and biotechnology program development. During his career he has developed, directed and implemented biotechnology and biomanufacturing training courses at Worcester Polytechnic Institute, Utah State University, Penn State University and internationally. He has delivered bioprocessing training programs on-site in numerous countries, including, China, Dominican Republic, Egypt, Indonesia, Iraq, Korea, Malaysia, Philippines, Puerto Rico, Vietnam, Thailand, Taiwan, and Singapore. His present research emphasis is on bioprocessing utilizing mammalian cell systems for production of recombinant proteins and vaccines. He received his Ph.D. from Penn State University with emphasis on toxicology and genotoxic effects of environmental pollutants on human health.

Andrew_SalazarAndrew Salazar, M.Sc., Scientist, Biomaterial and Technology, Merck Lifescience

Andrew Salazar is a biochemist by training with a Master’s degree in Virology. Through an industrial collaboration with the University of Marburg, Germany, he is pursuing his Ph.D. at Merck Lifescience (Sigma Millipore), based in Darmstadt Germany. The lab that he is working with endeavors to understand the behavior of cell culture raw material in solution, under dynamic as well as equilibrium conditions. This is aimed at generating novel strategies for the use of raw materials and innovative way to solve existing raw material-related difficulties.


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