Last October 21st took place our first 4TE talk, a 20-minute conversation where we invite remarkable people to talk about important topics for the Pharma and Biopharma industries. And our first guest was Stephan Krause, Head of Product Quality at AstraZeneca Biologics.  

If you missed it, don’t need to worry about it. In this blog post, we’ll give you an overview of what the talk is about and all the important insights. Let’s have a look! 

Let’s dive into the talk’s main topic. 

Well, the topic of the first 4TE talk was about Comparability over Lifecycle of Innovative Biologic Products: from ICH Q5E to ICH Q12.   To keep it fluid, it took the shape of a Q&A where participants also had the opportunity to ask questions to Stephan. 

1st Question: Challenges on Comparability on Early Development Stages. 

We started our conversation with a focus on early development stages considering the context of new biological drug substances and drug products.  

So, in this first part, Stephan shared his experience on comparability studies challenges and what are the key aspects to develop adequate comparability assessments on these early development stages. 

This topic led us to a question related to the use of quality risk management on comparability assessments. 

2nd Question: Risk Management Considerations on Comparability Studies. 

Focusing on ICH Q5E, which is a key guideline on comparability, we know that some risk concepts are not explicit. And why did this happen? Because ICH Q5E was published before ICH Q9.  

Besides that, we all agree that risk management is an expectation of the regulators to have sound quality risk management practices employed in this field.  For Stephan, risk assessments are not an option and, of course, are clearly expected by all the agencies. 

Also, for him, even in the early stages we must do risk assessments and it’s highly recommended when it comes to comparability studies.  

3rd Question: Key aspects on CDMO Selection. 

CDMO’s were also a topic of discussion. The subject of comparability assessments is often required when biological products are transferred to a CDMO. So, it’s important to know what critical points when selecting a CDMO. As a result of this analysis, it’s possible to anticipate potential comparability issues.  

For Stephan, a “Confident CDMO” must have experience in: 

  • Tech transfer
  • Development 
  • Manufacturing 
  • Testing 
  • Similar products 

In addition, a CDMO must be proficient in Change control and QRM, Phase-Appropriate QS and Investigation. By having all these key aspects, all CDMO’s are ready to work with you in every kind of situation. 

4th Question: Role of Digital Tools applied to Comparability Studies. 

And last, but not least. We finished our conversation with the discussion of the role of digitalisation and predictive tools that we can be apply to comparability.  

For Stephan, digital tools can be helpful when it comes to visualizing the impact of manufacturing changes on product quality. 

Do you want to know a little bit more about Comparability? 

So, we hope this summary picked up your curiosity!

If you would like to know more about Comparability, just click here to watch the full version of the first 4TE Talk

Stay tuned for what is coming next! 

This was just the first of many 4TE talks we are working on! Stay tuned to our blog post or even on our social networks to know first-hand the next 4TE events.