Finding a Root-Cause in a Filter Clogging at Drug Product Filtration

This ValGenesis story is about how we helped a company finding a root-cause associated to Filter Clogging. Would you like to know more? Keep reading!

Imagine that your company is producing a Monoclonal Antibody (mAB) but, due to a few constraints, the production is facing a delay. 

You have already tried many ways to find the root-cause of the problem but, unfortunately, without success. And, because of that, the quality and the revenue of your products started to become compromised. 

Let’s Investigate What Happened There! 

Our story’s main character faced a problem during the production of a mAB, due to a delay caused by a filter clogging at drug product (DP) filtration.  

Despite the many attempts to find the root cause, they could not conclude on the cause for the problem. So, they decided to get specialized assistance. 

How did we Support the Investigation of the Root-cause in a Filter Clogging? 

As the quality of the product and the revenue had become compromised, it was essential to act quickly! Our intervention started with a thorough process analysis: 

• Starting by analyzing the historical process data from both Upstream and Downstream Processes (USP + DSP) for three different production sites. 
• Investigating the process history spanning several years of production. 

We realized the performance of MVDA and statistical analysis to investigate the existence of compounded effects.

By following these approaches, we could identify a root cause that arose from a combination of USP and DSP factors that were causing filter clogging.

How did the Company Benefit From our Intervention? 

Our solution started with finding that the metabolites intake rates during USP was triggering the issue, hence the data quality issues and procedures were solved accordingly. Also, more than identifying the root-cause, the solution was deployed to every production site, assuring that the production was resumed without further issues and ensuring improved and consistent market supply.  

Our intervention was very relevant for the company’s success since it facilitated and streamlined all future troubleshooting activities.

Our Experience in Finding Root-causes of Process Deviations

If your processes are not yielding what you are expecting or if you have tried already different approaches to find a solution but the problem remains, we’ve got the best solution for you. 

Look at our Process Troubleshooting solution. Feel free to tell us about any challenges you may have; we’ll do our best to help!