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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What are some of the major trends in raw material management strategy from a technical perspective?

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 examines:
What do you see as some of the major trends in raw material management strategy from a technical perspective?

You know, moving forward with raw material management – particularly on the technical side – I think what you tend to see is --- one of the big things is that it is first increasing our visibility to raw materials. I think at one point we just sort of received things in, we looked at the C of A, and we accepted it as is. I think one of the trends you are seeing now are more end users are going out to the suppliers, visiting their manufacturing sites and really gaining a deeper appreciation for the manufacturing processes of those raw materials. And also trying to get visibility all the way back to the point of origin of manufacturing those raw materials.

So, I think one of the things that we’ve gained an appreciation for, as well, is that particularly in the pharmaceutical industry often there are distributors between the point of manufacture and the final customer of that raw material.

I think one of the other areas, both from a risk mitigation and supply chain standpoint – that that has been in the industry a little bit in terms of managing security and supply, but also from a technical perspective – is understanding all the way back to the point of origin and how those raw materials are made because they are not always equivalent across different suppliers or different raw material sources. I think as we gain that understanding, we are starting to be able to make some linkages between the kinds of issues that can arise, depending on the manufacturing process. An example would be a salt mine, for instance, directly or is it maybe a by-product of another manufacturing process. That could impact the impurity profile, for instance, of that salt product that is used in the cell culture media.

I think another area, as well, is going then and actually trying to link the supplier’s raw materials with our manufacturing processes as a customer. I think in the past sometimes, having worked both in the supply side and as a customer, you would supply raw materials to a customer, but you wouldn’t know a whole lot about how those raw materials are being used in the manufacturing process. I think now with increased collaboration between suppliers and the customers, I think we are starting to see more knowledge being exchanged in terms of both the way that a raw material is produced, but then also the way that that raw material is used in the manufacturing process. And that is allowing us, then, to start to be able to connect. Critical attributes in the manufacturing of that raw material to critical process performance parameters in the use of that raw material in manufacturing.

Download David's full podcast here.

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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