The Bioprocessing Summit

Short Course 1: OPTIMIZING MEDIA – Achieving Super Soup

Monday, August 19, 2013 | 8:30 to 11:30am

 

8:30 Chairperson’s Remarks

Robin Ng, Ph.D., Process Science Fellow, Life Technologies Corp.
 

8:45 Fundamental Aspects to Successful Media Optimization  

Martin Jordan, Ph.D., Scientist, Biotech Process Sciences - Medium Development, Merck Serono SA

The cell culture media has a key role for all important aspects of the upstream process. Particularly the performance and the robustness of the production process benefit from a well optimized medium. Unfortunately media optimization takes time and may delay projects. Thus platform media (internal and/or commercial media) are used and optimization aims at adapting the medium to the specific needs of the product. As a support to choose the proper strategy, the following points will be discussed:
    • Tools and expertise that are needed
    • Comparison of different approaches
    • Key components of the medium
    • Manufacturing aspects
    • Media specification and testing

9:15 Medium Design: An Approach to Develop Medium for the Cell Culture Platform  

Karlheinz Landauer, Ph.D., COO, Operative Departments, Celonic AG

The chemically defined, animal component free basal medium was tested in several batch and fed-batch experiments in comparison to the best in off-the-shelf media and found to be favorable in terms of volumetric product concentration at harvest with values of plus 10% to 60%. The cell density improved by a factor of three, and longevity (viability of the culture) was increased by a factor of two. Depending of the specific cell line the medium can be adapted to the needs of the project, by adaptation of component groups like fatty acids (growth), vitamins (specific productivity) or trace elements (glycosylation pattern).

9:45 Effect of Cell Culture Media Selection on Cell-Based Assays

Brian Posey, Product Development Manager, Corning Life Sciences

With the numerous variations of commercially available cell culture media on the market how do you select the right one for your application. This seminar will highlight the differences between cell culture media composition and the impact of these components on the growth and response of cell lines cultured in vitro.

10:00 Break

10:30 Challenges and Tradeoffs in Developing a Scalable mAb Process on a Constrained Budget: A Case Study  

Steven Chamow, Ph.D., Biopharmaceutical Consulting, Chamow & Associates, Inc.

Under the difficult financing climate for biotech start-ups of the past few years, small companies have been increasingly forced to develop manufacturing processes under significant budget constraints. This environment presents added challenges, but also opportunities, to develop resourceful, effective strategies to arrive at a robust, scalable process. In working with a small-company client to develop an upstream process for a recombinant human mAb expressed in NS0 cells, we were faced with this challenge. The project goal was to develop a scalable production process suitable for clinical Phase I/II that would ultimately be transferred to a CMO for scale-up and clinical production. Due to our limited capital budget, process development necessarily involved the use of recycled and in-house modified equipment with minimal online monitoring. Our process was developed using a strategy to screen basal media and supplements in high-throughput 50 mL spin tubes, using simple instrumentation for measuring cell growth and productivity. A single 3L Applikon bioreactor was used to perform sequential cell culture runs to test operating parameters. Ultimately, a fed-batch process was successfully developed and transferred. Challenges and tradeoffs inherent in this type of approach will be discussed.

11:00 Development of an Agnostic Medium Platform for CHO Fed-batch Culture: Balancing Productivity and Product Quality
Yao-ming Huang, Ph.D., Principal Engineer, Technical Development, Biogen Idec

This presentation will summarize recent efforts that the biopharmaceutical industry has undertaken to develop medium platforms that are suitable for multiple CHO cell lines expressing different proteins with vastly different product quality attributes.  Though process parameters may impact process performance and product quality, medium formulations and their raw material sources play an even greater role in determining the robustness of a cell culture process.  The many lessons learned while balancing productivity and product quality during process intensification will be discussed. 

11:30 Close of “Optimizing Media” Short Course


SPEAKER BIOGRAPHIES

Robin NgRobin Ng, Ph.D., Process Science Fellow, Life Technologies Corp.

Robin received his PhD in Chemical and Biomolecular Engineering from The Ohio State University, focusing on three-dimensional cell culture and process development. Soon after his graduation, he joined Goodwin Biotechnology, Inc where he led cell culture process development group. During his tenure at Goodwin, he managed several development projects including media development, process optimization, and technology transfer involving various cell lines. He also supported facility start-up for 500L stainless steel bioreactor at Goodwin. At Shire HGT, Robin has worked on several projects involving experimental design, risk assessment, data analysis, and process simulation and modeling, and process scale up. Besides technology transfer, he provided technical support during the disposable facility start up at Shire Lexington facility. Robin serves on the advisory board of the Society for Biological Engineering and scientific advisor for Bioprocessing Summit conference. Robin is also a Director for Food, Pharmaceuticals and Bioengineering Division of the American Institute of Chemical Engineers.

Martin Jordan, Ph.D.Martin Jordan, Ph.D., Scientist, Biotech Process Sciences - Medium Development, Merck Serono SA

During more than 20 years of activity in upstream processes, Martin Jordan accumulated a solid expertise in different topics of mammalian cell culture. This includes his thesis about the shear stress sensitivity of cells, the optimization of large-scale transient expression at Genentech (1993-1995) and many additional studies and publications during 9 years within the laboratory of professor Florian Wurm at the EPFL in Switzerland. New disposable products that successfully entered the market as “tubespin”, “Mini PCV” or Volupac™ were also invented during this period. In 2005, Martin Jordan joined the Merck Serono manufacturing site in Vevey as head of the media development group. As a scientist, he continuously improves cell culture media and fed-batch processes.

Karlheinz LandauerKarlheinz Landauer, Ph.D., COO, Operative Departments, Celonic AG

2002 PhD in Biotechnology at University of Applied Life Sciences in Vienna 2002 - 2006 Heading Cell Culture Labs at Igeneon (Vienna) with focus on Process Development of CHO Cells 2006 - 2007 Media Development at Celltrion; South Korea 2007 - 2010 Heading Cell Culture Labs at Celonic AG, Basel 2011 to date COO at Celonic AG

Posey_BrianBrian Posey, Product Development Manager, Corning Life Sciences

Brian Posey has over 10 years’ experience in cell biology and cGMP manufacturing and as the Development Manager for Corning cellgro® brand of cell culture media for over 3 years, he is responsible for designing finished product specifications, reviewing raw material quality specifications, authoring industrial scale formulation instructions, implementing manufacturing process improvements, and developing new products.  

Steven Chamow, Ph.D.Steven Chamow, Ph.D., Biopharmaceutical Consulting, Chamow & Associates, Inc.

Steven Chamow, Ph.D., has 25 years of experience in biopharmaceutical product development. He is currently a principal consultant helping to formulate and implement product development strategies for biotechnology companies. During his career, he has contributed to the development of three marketed products (Avastin, Natrecor, Vectibix). Previously, he served as Senior Vice President, CMC, at Intradigm Corporation, a private biopharmaceutical company focused on developing RNAi therapeutics (acquired by Silence Therapeutics). Prior to Intradigm, Dr. Chamow was Vice President, Process Sciences, at Genitope Corporation and at Abgenix, Inc., (acquired by Amgen) where he built the company’s process sciences department and helped to lead the design and construction of Abgenix’ award‑winning production facility in Fremont, CA (recently sold by Amgen to Boehringer Ingelheim to become its first North American production facility). Before Abgenix, he served as Director of Biopharmaceutical Development at Scios, Inc. (acquired by J&J), and as a scientist and senior scientist in process development at Genentech, Inc. (acquired by Roche). Dr. Chamow was educated at the University of California (UC Santa Cruz, B.A. in biology; UC Davis, Ph.D. in biochemistry), and completed postdoctoral training at the National Institutes of Health. He is author or co-author of more than 50 scientific publications and patents and co-editor of a 1999 book entitled Antibody Fusion Proteins. Dr. Chamow is working on a manuscript for a second book on the same topic to be published in 2014.

Yao-Ming-HuangYao-ming Huang, Ph.D., Principal, BioPharm Development Engineer, Biogen Idec

Dr. Huang is a Principal Engineer in Technical Development at Biogen Idec. He joined IDEC pharmaceuticals in 2001, and since then has been involved in process development of a large number of clinical projects and technology programs. He led the team developing chemically defined media that support the cell culture process platform of several clinical programs. Most recently Yao-Ming and his team have been involved in biosimilar work and undertaking complex product quality challenges.

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