SC 1 - Optimizing Media – Achieving Super Soup

Monday, August 3
9:00—11:30 am

9:00     Fundamental Aspects to Successful Media Optimization

Instructor:  Kamal Rashid, Ph.D., Director, Biomanufacturing Education and Training Center, 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.

In this presentation, an overview of media for cell culture will be discussed with emphasis on:

• The importance of media for cell growth
• Media composition
• Media supplementations
• The importance of amino acids in the media
• Serum and serum free media
• Protein free media

9:45     The Design of Cell Culture Media for the Production of High Quality Biopharmaceuticals

Instructor:  Michael Butler, Ph.D., Distinguished Professor, Animal Cell Technology, Microbiology, University of Manitoba Various types of defined media that include protein-free, animal component-free and chemically defined will be discussed in the context of maximizing productivity of biopharmaceutical products form mammalian cells in culture. 

Strategies for formulating production media may include blending of basal media, the addition of selected peptide hydrolysates or the statistical design of experiments to establish key supplements that provide the growth factors necessary to replace serum. The approaches may include a top-down analysis of complex additives or bottom-up addition of bioactive chemical components. Both approaches can lead to the ultimate goal of a fully defined robust culture media that ensures the consistent production of a high quality product.

• Serum-free media may be formulated for rapid cell growth and productivity
• Blending of basal media can ensure a rich formulation for cell metabolism
• Fractionation of complex components such as peptide hydrolysates can identify bioactivity
• Statistical tools are available for rapid identification of vital growth factors
• The eventual goal is a robust formulation ensuring high productivity of a high quality product

10:30     Refreshment Break

11:00     Efficient Media Optimization

Instructor:  David Brühlmann, MSc., Biotech Technology and Innovation, Biotech Process Sciences, Merck Serono SA

The workshop will consist in two major parts: Part 1: General fundamental aspects of cell culture media, Part 2: Current media development efforts of the Merck Serono Biotech Process Sciences group in Vevey

Main topics discussed will be:

• Media components
• Stability
• Media optimization
• Tuning of protein quality attributes by media design

11:30 Close of "Optimizing Media" Short Course 

Speaker Biographies:

Kamal Rashid, Ph.D., Director, Biomanufacturing Education and Training Center, Worcester Polytechnic Institute

I have over thirty years of academic experience in both research and Biotechnology educational program development. During my career I have developed, directed and implemented biotechnology training courses at Utah State University, Penn State University and internationally. I joined Utah State University in July 2000 as the Biotechnology Center’s Associate Director and Research Professor of Toxicology. During my tenure at Utah State University, I developed and equipped the bioprocess facility at the Center with the most advanced bioreactors and fermenters that are utilized in both research and training programs. While at Utah State University I received a multi-year, multimillion dollar grant from the US Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA) to train employees of vaccine manufacturing facilities from eleven countries in the latest advances in cell-based vaccine production with emphasis of Influenza vaccines. These countries included Brazil, Egypt, Kazakhstan, Korea, India, Indonesia, Mexico, Romania, Russia, Serbia, South Africa, Thailand and Vietnam.

Prior to joining USU, I was a faculty member in the Department of Biochemistry and Molecular Biology at the Pennsylvania State University. While at Penn State, I conducted research on the impact of environmental pollutants on human health, developed and taught biotechnology undergraduate courses, developed and directed the Penn State biotechnology training programs, directed the Summer Symposium in Molecular Biology for ten years and was the key faculty in the development of the biotechnology undergraduate degree and the course curriculum in the department. I have delivered numerous lectures and training programs in several countries, including Canada, China, Dominican Republic, Egypt, Indonesia, Iraq, Korea, Malaysia, Philippines, Puerto Rico, Vietnam, Thailand, Taiwan, Singapore and US. I am recognized for my continuing education, teaching and international programs. I received a national Faculty Service Award in 1997 from US University Continuing Education Association for my “meritorious service to Penn State University”. I was also honored in 2011 as the international professor of the year in College of Agriculture at Utah State University.

Michael Butler, Ph.D., Distinguished Professor, Animal Cell Technology, Microbiology, University of Manitoba

Michael Butler is a Distinguished Professor of Animal Cell Technology at the University of Manitoba, Canada. His previous appointments include Associate Dean of Scientific Research at Manitoba and Principal Lecturer in Biotechnology at Manchester Metropolitan University. He has also been a Visiting Scientist at MIT (USA), Animal Virus Institue (Pirbright, UK) and the Universities of Oxford and Rio de Janeiro. He holds degrees in Chemistry and Biochemistry from the Universities of Birmingham, London (UK) and Waterloo (Canada). His research work and teaching focuses on the development of bioprocesses using mammalian cells for the production of recombinant proteins, monoclonal antibodies and viral vaccines. He is particularly interested in the bioprocess conditions that can be used to control the biochemical structure of glycoproteins. He has always collaborated closely with industry and is a past recipient of the Canadian national Synergy Award for University-Industry innovation. He is presently 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.

David Brühlmann, MSc., Biotech Technology and Innovation, Biotech Process Sciences, Merck Serono SA

After leading several international technology transfers, David Brühlmann took on the challenge to conduct a PhD research project in the field of glycosylation at Merck Serono S.A in collaboration with the University of Würzburg, Germany. The research focuses on the tuning of the glycan profile of recombinant proteins using cell culture media design by adding beyond the commonly known media components1. The goal is the development of a strategy allowing to enhance the pharmacological properties of tomorrows’ therapeutic molecules.

In his preceding role as process coordinator David at Merck Serono S.A. was responsible for leading international technology transfers of clinical and marketed products to state-of-the-art intermediate and large-scale production facilities and providing expertise in recombinant protein cell culture and purification in routine production investigations and troubleshooting. In the frame of his leadership and driving of process improvement projects, scale-down and scale-up of processes for production he played an active role in performing process validation, comparability studies and creation of CMC modules for product registration.

Before joining Merck Serono, David Brühlmann worked as a process engineer at Nestlé Nespresso where he was in charge of the commissioning of new-generation roasters and filling lines. David Brühlmann earned his MSc in chemical engineering at the Swiss Federal Institute of Technology (EPFL).