Bioproduction

As I was researching our Quality by Design track for this years’ BioProduction PAT was a topic that many people wanted hear more about.  

Regulatory guidelines encourage biopharm manufacturers to implement PAT to improve and advance their process developments, in order to reduce time and cost in the whole production line.  However, there are aspects of the guidelines that are still unclear to many. Industry do not know when and where to implement PAT and what technology platforms to use. 

Have you successfully implemented PAT into your production system? 

If so please share your experiences with us as I found that very few people have practical experience with this and true case study material.  

Where does PAT fit with the lifecycle initiative and Quality by Design? 

Does it sit alone or fit in the whole system? 

I look forward to hearing your thoughts on this hot topic.  

Gemma Burns

Hi my name is Gemma and I produced our Quality by Design track.  

* Quality by Design * Process Analytical Technologies * Design Space * Systems Biology * Manufacturing Space * Quality Risk Management  

With many of these concepts being relatively new to the biopharmaceutical industry one question that arose continuously throughout my research was: 

How do all these fit together? 

Harmonising these concepts is an extremely challenging task but it is one that I think industry are beginning to have to face. They know that the quality outcome must be designed into the process itself rather than relying on final product testing. This means that manufacturers are having to make larger investments earlier in the product life cycle during process development, in advance of approved commercial operations.   It is clearly an important issue that, if implemented correctly could help to save valuable resources.   

The single hottest topic from my research on Quality by Design was design space and upstream processing. What are the best ways to classify the parameters and control terminology? How does your company establish the appropriate design space during upstream processing and what are the advantages of this?  

I hope that some of you will share your thoughts and discuss ideas for moving forward with process design and control.