Tuesday, March 11, 2014

How is the growing use of chemically-defined media increasing our understanding of the complexity cell culture manufacturing?

This week, we turn our sights to look at raw materials and supply chain management at Biopharmaceutical Development and Production Week.  Speaker David Kolwyk, M.S., MBA, Principle Scientist, Material Science, Amgen Inc. recently sat down to join us for an interview and previewed many of the topics he plans on look at during his presentation Strategies for Managing Impurities in Upstream Raw Materials.

Today, he looks at:
How is the growing use of chemically-defined media increasing our understanding of the complexity cell culture manufacturing?

When you look at the development of cell culture media, originally when we used, for instance, basal media plus fetal bovine serum – and fetal bovine serum was thousands, if not millions, of components in a supplement for the basal media that varied from year-to-year due to its biological origin. Or even when we went to hydrolysate and protein extracts. Once again, maybe it was just mostly protein, but it was thousands of different peptides, some vitamins, trace metals. It was very hard at that point to discern what was influencing or what components individually were influencing the performance of the cell culture process. You might find some markers. You might find some ratios of amino acids, but ultimately it was still fairly difficult. Whereas when you remove the chemically-defined media, at this point now you have a media, it has a defined list components – probably 50 to 70 different components. And that now makes it possible that you can really start to focus in and figure out which components in that media are actually critical to the performance of your manufacturing. And because they are chemically-defined components in the media, you can actually start to discern what attributes of those components are critical to your process performance. From doing that, you can then start to learn, “Okay if these attributes are important in this cell line, can I apply it to other processes? Can I further improve and increase the robustness of my media in such a way to minimize the impact of the variability of this component that is inherent to the manufacturing process?”

So, by moving to chemically-defined media, I think we’ve been able to build our understanding of how individual components in the cell culture process can impact our process performance and better develop strategies to be able to modulate and ensure that our processes are more robust and less susceptible to inherent variability in those cell culture components.

David will be presenting Strategies for Managing Impurities in Upstream Raw Materials on Wednesday, March 26 in San Diego.  For more information on her session and the rest or the program, download the agenda.  If you'd like to join us for Biopharmaceutical Development and Production Week, as a reader of this blog, when you register to join us and mention code BDP14BLOG, you can save 20% off the standard rate.

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