Wednesday, March 12, 2014

How are biopharmaceutical manufacturers managing the variability within their supplier base?

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 shares what he sees as some of the major trends in raw material management strategy from a technical perspective?

I think that there is a variety of ways that they’re doing that. I think what suppliers are doing right now, one of the things suppliers and manufacturers are collaborating on to work together on this is both exchange of data. In the past maybe you just received a certificate of analysis for your final product. Now some suppliers and some customers are exchanging more data. Maybe a certificate of manufacture with a list of the raw materials, maybe it’s a C of A for all the raw materials that were used in the cell culture media. So, they need more visibility to the components – the suppliers of those components – into the manufacturing process.

I think another thing, as well, I think end users and biopharmaceutical manufacturers are doing more work upon incoming receipts. So, they are applying new technologies, such as raman spectroscopy to create a spectral reading, which creates a richer data set on those individual raw materials that are brought in. And then what they can do is employ tools, such as multivarient analysis to be able to detect weak signals from those richer data sets. And that starts to be able to point directionally as to whether or not there are differences lot-to-lot that are impacting the manufacturing process.

I think by combining both some of these analytical tools, such as Ramen and some of the statistical analysis tools, such as multi-varient analysis and then also the increased collaboration with our suppliers and being able to get data set and more visibility to specific places. We are starting now to be able to map out and better understand exactly how components within a complex raw material, such as cell culture media, can impact the process performance in our manufacturing environment.

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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