This is a 4TE Story on how we helped a company finding the Root-Cause in mAB Production. Would you like to know more? Keep reading!

Imagine that you’re producing Monoclonal Antibody (mAB) products, and something goes wrong. You spend time, energy and resources trying to find the problem without success. Your timelines and your product introduction to the market keep getting more and more compromised.

The problem occurred during pilot-scale production, and it was causing considerable delays to the clinical trials and the tech transfer to production site.

So, what happened here?

This time, Company X (let’s name the company like this), detected a high level of an impurity in bulk product batches during late-stage development.

After a year of unsuccessful root-cause analysis attempts and the efforts of many SMEs it was time to look for help!

You can guess who jumped right in to help. Yes, that’s right, it was us!

And how did we help them finding the Root-Cause in mAB Production?

First things first! We needed to identify the root-causes and we needed to do it quickly. And we did so by identifying the critical to quality variability sources that could help us solving this case.

However, just this wasn’t enough. We performed an end-to-end (E2E) analysis to help us understand and then improve the process as a whole.

And how did we do it? Well, it was something like this:

  • We started by looking into the plant layouts and analysing them;
  • Then we compared the process data from before and after the problem was detected;
  • We investigated the media components and media preparation;
  • And then we evaluated the Upstream (USP) and Downstream (DSP) Processes’ performance using the In-process Control (IPC) and the bioanalytical data available.

In order to make this analysis more robust, we used a Multivariate Data Analysis approach.

Time for the results!

We’re not going to lie, we’re proud of them!

Due to our approach, we were able to identify and address the root-causes. We did so with no negative impact on process yield and the other Quality Attributes.

But, more than that, we identified the critical to quality variability sources. Why was that good? Because it allowed us find even more improvement opportunities in the process!

And at the end of the day, our client got quite a few gains:

  • Product Development was resumed;
  • Time-to-market was ensured.
  • The client obtained a more robust, efficient, and predictable version of its process.

It was a successful intervention!

We have some experience finding root-causes in processes

If you’d like to know more about how we find the root-cause in processes, then you can check out our post on Finding the Root-Cause in a Process: a 4TE Story.

Want to know more?

If you have some process not yielding what you expect, we’ve got solid strategies that can help you!

Take a look at our Root-Cause Analysis and Corrective and Preventive Action Services. Feel free to tell us about any challenges you may have, we’ll do our best to help!