Continuous Process Validation at Biogen Idec

Today, we start our preview of the Biopharmaceutical Development and Process Week event.  We had a chance to sit down with many of the speakers presenting at the event.   Today, Greg Stromberg, the Manager of Process Analytics, RTP Manufacturing Sciences, at Biogen Idec gives us an insight into the process validation at Biogen Idec.

From a standpoint of continuous process verification, which is the new FDA paradigm, we are not really new anymore. It's probably two to three years old now. We are working through applying and developing these types of tools at Biogen Idec and we’re honestly trying to lead the industry in it. We have a lot of different modeling tools and a lot of different advance analytics tools and data management tools that we are working to implement all the way from raw material to drug product – specifically in the drug substance world, which is where we are farthest along. We have a lot of structure around the actual compliant data management. And then along those lines we can walk that down into supply and reporting, advance modeling, predictable modeling – basically moving up the pyramid towards parametric release. That’s the dream and vision. 

Currently work is going on in both the drug substance – our large molecule standpoint – but also API and small molecule standpoint. So, that’s currently where we’re working. 

The talk that I plan on going through is covering what we’ve done so far and where we want to go. Obviously, there are always things that you can improve upon. There are obviously things that others are doing in the industry that we’re not and there are other industries that are a lot better at this than we are by automotive industry and chemical industry. So, how do we ensure that our batch processes are in some of our continuous monitoring --- system and monitoring tools? How do we ensure that we meet that need and goal for our business and for our patients?

Greg will be a part of the panel presentation Implication and Impact of Adopting a Lifecycle Concept for Process Validation in the Biopharmaceutical industry.  For more information on this presentation, download the agenda.  If you'd like to join Greg this March 24-27 in San Diego at Biopharmaceutical Development and Process Week, as a reader of this blog when you register to join us and mention code BDP14BLOG and you'll save 20% off the standard rate!

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